cGARD History

04th Jan 2013 (Database Review)

The following regulations have been updated

  • ICH E2B(R3)

    Revised on 31 Oct 2011

    Revision of the implementation guide to reflect current practice and technologies

  • ICH E14 Q and A

    Revised on 05 Apr 2012

    Revision of the Q&A's by the steering committee

  • ICH S6(R1)

    Revised on 30 Jun 2011

    Addendum to provide clarification of: Species selection, Study Design, Immunogenicity, Reproductive and developmental toxicity and Assessment of Carcinogenic Potential.

    Scientific advances and experience gains since pbli8cation of the original ICH S6 guideline call for this addendum.

    The addendum reached Step 4 of the harmonisation process in June 2011 and was integrated as Part II of the core Guideline that was then renamed S6(R1).

  • Eudralex Volume 4 Introduction

    Revised on 31 Dec 2010

    Introduction text was updated and a new Part III introducted to Volume 4.

  • Eudralex Volume 9B

    Revised on 31 Oct 2011

    Volume 9B - multiple revisions.

  • 21 CFR Part 1

    Revised on 27 Jan 2012

    Amendment to bring general regulations to include tobacco products in light of the Family Smoking Prevention and Tobacco Control Act.

    Revised on 23 Feb 2012

    Amendments to record availability regulations in response to amendments to the Federal Food, Drug and Cosmetic Act made by the FDA Food Safety modernization Act (FSMA).

  • 21 CFR Part 7

    Revised on 27 Jan 2012

    Amendment to bring general regulations to include tobacco products in light of the Family Smoking Prevention and Tobacco Control Act.

  • 21 CFR Part 16

    Revised on 27 Jan 2012

    Amendment to bring general regulations to include tobacco products in light of the Family Smoking Prevention and Tobacco Control Act.

    Revised on 24 Apr 2012

    Amendment to expand the scope of Clinical Investigator Disqualification. Under this rule, when the Commissioner of Food and Drugs determines that in investigator is ineligible to receive on king of test article (drugs, devices of new animal drugs), the investigator will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA.

  • 21 CFR Part 20

    Revised on 16 Mar 2012

    Amendment to the requirement to publish Written Agreements and Memoranda of Understanding (MOUs) with other departments, Agencies and Organizations in the Federal Register.

    As the FDA already post on-going agreements and MOU with other departments, Agencies and on the FDA web site, this requirement is no longer necessary.

    Revised on 22 Jun 2012

    The revision of 16 Mar 2012 has been withdrawn as a result of receiving adverse comments.

    Revised on 17 Aug 2012

    The revision of 16 Mar 2012 is re-instated.

  • 21 CFR Part 21

    Revised on 20 Jul 2012

    Implementation of new system of records, 09-10-0020 "FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC".

    HHS / FDA is exempting this system of records from certain requirements of the Privacy Act to protect integrity of the FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations

  • 21 CFR Part 74

    Revised on 29 Jun 2012

    Revision of requirements for:

    D&C Red No 6 and D&C Red No 7 by replacing the current specification for "Ether-soluble matter" with a maximum limit of 0.015 per-cent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-maphthalenol.

    Revised on 05 Sep 2012

    Confirmation of the effective date is confirmed as 7 Aug 2012

  • 21 CFR Part 211

    Revised on 13 Mar 2012

    Amendment of the Packaging and Labelling control provisions for human and veterinary products by limiting the application of special control procedures for the cut labelling to immediate container labels, individual unit cartons or multiunit cartons containing immediate contains that are not packaged in individual unit cartons.

    FDA is also permitting the use of any automated technique, including differentiation by labelling size and shape that physically prevents incorrect labelling from being processed by labelling and packaging equipment when cut labelling is used.

  • 21 CFR Part 310

    Revised on 08 May 2012

    Delay to the compliance dates for the final rule for Over-The-Counter (OTC) sunscreen drug products that published in the Federal Register of June 17,2012 (76 FR 35620).

    The final rule establishes labelling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications.

    Labelling requirements are also modified.

  • 21 CFR Part 312

    Revised on 24 Apr 2012

    Amendment to expand the scope of Clinical Investigator Disqualification. Under this rule, when the Commissioner of Food and Drugs determines that in investigator is ineligible to receive on king of test article (drugs, devices of new animal drugs), the investigator will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA.

    FDA is also amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.

  • 21 CFR Part 314

    Revised on 13 Dec 2011

    Issuing an interim final rule amending its post-marketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act.

    Provisions of the act require at least 6 months notice before discontinuance of manufacture. Meaning of sole manufacturer and discontinuance are modified by these changes.

    Changes to improve response to potential drug shortages

  • 21 CFR Part 600

    Revised on 27 Apr 2012

    Amendments of sterility test requirements for biological products.

    Rule provides greater flexibility, as appropriate, and encourages the use of the most appropriate and state-of-the-art test methods for assuring safety of biological products.

  • 21 CFR Part 606

    Revised on 22 Dec 2012

    Revised requirements for labelling of blood and blood components intended for use in transfusion of further manufacture by combining, simplifying and updating specific regulations applicable to labelling and circulars of information.

    Changes facilitate the use of machine readable information.

  • 21 CFR Part 610

    Revised on 22 Dec 2012

    Revised requirements for labelling of blood and blood components intended for use in transfusion of further manufacture by combining, simplifying and updating specific regulations applicable to labelling and circulars of information.

    Changes facilitate the use of machine readable information.

    Revised on 27 Apr 2012

    Amendments of sterility test requirements for biological products.

    Rule provides greater flexibility, as appropriate, and encourages the use of the most appropriate and state-of-the-art test methods for assuring safety of biological products.

  • 21 CFR Part 640

    Revised on 22 Dec 2012

    Revised requirements for labelling of blood and blood components intended for use in transfusion of further manufacture by combining, simplifying and updating specific regulations applicable to labelling and circulars of information.

    Changes facilitate the use of machine readable information.

  • 21 CFR Part 680

    Revised on 27 Apr 2012

    Amendments of sterility test requirements for biological products.

    Rule provides greater flexibility, as appropriate, and encourages the use of the most appropriate and state-of-the-art test methods for assuring safety of biological products.

    Revised on 24 May 2012

    Correction to an inaccurate citation in the codified section of the rule.

  • 21 CFR Part 807

    Revised on 27 Jul 2012

    Amended to reflect statutory amendments to the device registration and list provisions of the Federal Food, Drug and Cosmetic Act.

    Amendments require domestic and foreign device establishment to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms and also specify the timeframes when establishments are required to submit such information.

    In addition, this final rule facilitates FDAs collection of additional registration information from foreign establishments are required by the Public Health security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)

  • 21 CFR Part 812

    Revised on 24 Apr 2012

    Amendment to expand the scope of Clinical Investigator Disqualification. Under this rule, when the Commissioner of Food and Drugs determines that in investigator is ineligible to receive on king of test article (drugs, devices of new animal drugs), the investigator will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA.

    FDA is also amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.

  • 21 CFR Part 870

    Revised on 09 Feb 2012

    The FDA is classifying the endovascular suturing system into class II (Special Controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

    Revised on 18 Jun 2012

    The FDA is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker programmers

    Revised on 18 Jun 2012

    The FDA is issuing a final rule to require the filing a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker pulse generators.

    Revised on 18 Jun 2012

    The FDA is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular permanent pacemaker electrode.

  • 21 CFR Part 1300

    Revised on 15 Mar 2012

    Adjustment of fee schedule for DEA registration and re-registration fees.

  • 21 CFR Part 1303

    Revised on 27 Jan 2012

    Minor correction of a spelling mistake in section 11c.

  • 21 CFR Part 1304

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1305

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1306

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1308

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1309

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1310

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1312

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1313

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1314

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

  • 21 CFR Part 1316

    Revised on 13 Jan 2012

    Update to alphabetise definitions and eliminate numeric listings in those listings in order to simplify future rulemakings where additional definitions are added or deleted.

 

25th June 2011 (Database Review)

The following documents have been updated

  • Volume 4 Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use - Annex 11: Computerised Systems

Reason for update:- the Annex has been revised in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide.

Deadline for coming into operation: 30 June 2011

  • Volume 4 Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use - Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma

Reason for update:- the Annex has been revised in the light of Directive 2002/98/EC and relevant implementing directives setting standards of quality and safety for the collection and testing of human blood and blood components for all uses, including the manufacture of medicinal products.

Deadline for coming into operation: 30 November 2011

  • Volume 4 Good Manufacturing Practice - Medicinal Products for Human and Veterinary Use - Chapter 4: Documentation

Reason for update:- the sections on "generation and control of documentation" and "retention of documents" have been revised, in the light of the increasing use of electronic documents within the GMP environment.

Deadline for coming into operation: 30 June 2011

02nd Dec 2010

  • Server Updates

cGARD has now been upgraded to improve speed and access by increasing disk space on the hosted server which will also allow improved integration with ComplianceControl Centre and corporate users of cGARD to upload significantly more data.

Access to cGARD has not changed, however the following link is recommended, as this will permit contined access to the very latest version:

https://products.compliance-control.com/cGARD

  • Update to 21 CFR 878

21 CFR 878 has an additional part, 21CFR878.4683 Surgical Devices; Non-Powered suction apparatus device inteded for negative pressure wound therapy.

  • Update of ICH Q4B Annex: 1,2,3,4A,4B and 4C

Annexes have been updated to indicate acceptance by Canada Health of test procedures

  • ICH M2

Standard now defines specfic requirements for the common interchange of data

04th Oct 2010 (Database Review)

The following documents have been added to the DOCUMENTS repository

  • Good Clinical Laboratory Practice (Version 3)
    A Quality System for Labortories which undertake the Analysis of Samples from Clinical Trials.
    Produced by a Working Party of the Clinical Committee of BARQA
  • Good Clinical Laboratory Practice - World Health Organisation
    A Guideline to GCLP based on the BARQA guidelines

13th July 2010 (Database Review)

The following documents have been updated

  • 21 CFR 312 - update to the address for ANDA applicants to submit INDs for in vivo bioavailability and bioequivalence studies that are intended to support ANDAs.
  • 21 CFR 314 - update the address for applicants to submit ANDAs and ANDA amendments, supplements, and resubmissions.

28th June 2010 (Database Review)

The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2010,
for the final rule that appeared in the Federal Register of March 26, 2010. 
The final rule amended the color additive regulations by increasing the permitted use
level of bismuth citrate as a color additive in cosmetics intended for coloring 
hair on the scalp.

22nd June 2010 (Database Update Only)

The following documents have been updated

  • 21 CFR 312 - Investigational new drug application - Revised as of April 1, 2009
    Amendment to Contact Information for FDA Emergency Call Centre
  • 21 CFR 803 - - Medical Device Reporting - Revised as of April 1, 2009
    Amendment to Contact Information for FDA Emergency Call Centre

16th June 2010 (Database Update Only)

The following document has been added to the document repository

  • EudraLex Volume 2 Annex 2 (Draft) EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

9th June 2010 - cGARD 6.0 (Major Release)

cGARD 6.0 has been released to provide improved integration with ComplianceControl Centre.

Functionality in ComplianceControl Centre can now be easily tagged to regulatory articles in cGARD; allowing users to more clearly identify areas impacted by regulatory changes.

Version 6.0 is on average 900% faster when searching for information than the previous release (version 5.2), as well as containing even more regulations and documents.

The following features, changes have been incorporated in cGARD 6.0:

  • Improved news feed providing the very latest happenings within the industry
  • Orange Guide and FDA QSR information more easily identifiable
  • Revised top level menu structure, with Assessments now contained in File Menu with Compliance Subjects being replaced with Topics
  • Regulations, Documents and GMP Manual (if purchased) more easily selected from the top level menu, which are then displayed in the LHS Tree Menu
  • Limit to Compliance removed to increase search speed, with consideration for inclusion in future releases based on customer feedback
  • Saved Queries to be replaced by Load/Save View in a future release

An updated content statement for 6.0 release is available from our website:

http://www.compliance-control.com

04th May 2010 (Database Update Only)

The following regulations have been updated due to a change of address of the Centre for Devices and Radiological Health:

  • 21 CFR 1 - General Enforcement Regulations
  • 21 CFR 801 - Labeling
  • 21 CFR 803 - Medical Device Reporting
  • 21 CFR 807 - Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
  • 21 CFR 812 - Investigational Device Exemptions
  • 21 CFR 814 - Premarket Approval Of Medical Devices
  • 21 CFR 820 - Quality System Regulation
  • 21 CFR 860 - Medical Device Classification Procedures

26th April 2010 (Database Update Only)

The following regulation has been updated:

  • 21 CRF 2 - General Administrative Rulings and Decisions

The Food and Drug Administration (FDA), is amending regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires

DATES: Flunisolide 30 Jun 2011. Triamconolone 31 Dec 2010. Metaproterenol 14 Jun 2010. Pirbuterol 31 Dec 2013. Metered-dose cromolyn sodium human drugs administered by oral inhalation 31 Dec 2010. Metered-dose nedocromil sodium human drugs administered by oral inhalation 14 Jun 2010. Metered-dose ipratropium bromide and albuterol sulfate, in combination, administered by oral inhalation for human use.31 Dec 2013.

 

 

 

19th April 2010 (Database Update Only)

The following regulations have been updated:

  • ICH M4: The Common Technical Document

Common Technical Document is now produced as an electronic document. This has also required the removal of ICH M4E(R1), ICH M4S(R2), and ICH M4S(R2).

12th April 2010 (Database Update Only)

The following regulations have been updated:

  • 21 CFR 5 - Organisation

The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organization change in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

  • 21 CFR 10 - Administrative Practices and Procedures

The Food and Drug Administration (FDA) is amending its administrative regulations. This action is being taken to ensure accuracy and clarity in agency regulations.

  • 21 CFR 14 - Public Hearing Before a Public Advisory Committee

The Food and Drug Administration (FDA) is amending its regulations on public hearings before public advisory committees to reflect an internal change with respect to the staff that handles the nomination and selection process for nonvoting members representing consumer interests for standing technical advisory committees. FDA is also revising the address where the nominations for nonvoting members representing consumer interests should be submitted.

  • 21 CFR 814 - Premarket Approval of Medical Devices

Medical Devices; Paediatric Uses of Devices; Requirement for Submission of Information on Paediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Direct Final Rule

06th April 2010 (Database Update Only)

The following regulations have been updated:

  • 21 CFR 3 - Product Jurisdiction

Update to section 3.6 - Address and Telephone number of the Office of Combination Products (OCP). Updated to record the new address and telephone number for this office.

  • 21 CFR 73 - Listing of Color Additives exempt from certification.

Modifications to 73.2110 Bismuth citrate allowable levels from 0.5% to 2.0% for scalp hair cosmetic products.

15th March 2010 (Database Update Only)

The following regulations have been updated:

  • 21 CFR 333 - Topical Antimicrobial products for OTC human use

Change to include Benzoyl-peroxide as a Generally Recognised As Safe and Effective (GRASE) active ingredient.

22nd February 2010 (Database Update Only)

The following regulations have been amended:

  • EudraLex Volume 4: Good Manufacturing Practice Medicinal Products for Human and Veterinary Use - Part II

Extensively updated to bring the regulation into line with ICH Q9 guideline.

  • EudraLex Volume 4: Annex 6 - Manufacture of Medicinal Gasses

Clarification of what should be considered as a starting material as opposed to a bulk pharmaceutical product

  • EudraLex Volume 4: Annex 13 - Investigational Medicinal Products

Revision to reinforce the principal of independence between production and quality control functions in cases where the number of personnel involved is small.

08th February 2010 (Database Update Only)

The following regulations have been added:

  • HPFBI - Annex 13

New Guideline produced to match updated GMP Guidelines 2009

The following regulations have been removed:

  • HPFBI - Annex 2

Guideline has been dropped and replaced with Annex 13.

The following Draft Documents have been added:

  • ICH S6 (R1) - 29 Oct 2009
  • ICH S2 (R1) - 08 Feb 2010

31st January 2010 (Database Update Only)

The following regulations have been updated:

  • 21 CFR 210 - Current Good Manufacturing \practice in manufacturing, processing, packing, or holding of drugs; general

Changes to current good manufacturing practices for Positron Emission Tomography (PET) drugs.
(03 Dec 2009)

  • 21 CFR 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals

Changes to current good manufacturing practices for Positron Emission Tomography (PET) drugs.
(03 Dec 2009)

  • HPFBI Good Manufacturing Practices Guidelines 2002 Edition Version 2

Update to current version - HPFBI Good Manufacturing Practices (GMP) Guidelines 2009
(08 Nov 2009)

31st December 2009 (Database Update Only)

The following regulations have been updated:

  • SOR 98-282 Food and Drugs Act

Changes to replace "Certified Quality System" with "Certified Quality Management System".
(18 Nov 2009)

  • Eudralex Vol 4: EU Guidelines to Good Manufacturing Practices - Medicinal products for Human and Veterinary use.

Annex 7 0 Manufacture of Herbal Medicinal Products. Update to:

    • Specify application of GMP provisions for active substances used as starting materials
    • Changes relating to directive 2004/24/EC for traditional herbal medicinal products.
    • Collaboration between GMDP inspectors working group and Committee of Herbal Medicinal Products (HMPC)
      (01 Sep 2009)
  • ICH Q3C (R4) Impurities: Guidelines for Residual Solvents.

Update of Table2, Table 3 and Appendix 1 to reflect revision of the PDE?s for N-Methylpyrrolidone and Tetrahydrofuran.
(02 Feb 2009)

  • ICH Q8 (R2) Pharmaceutical Development

Correction to titles of "Figure 2a" and "Figure 2b" of "Example 2" on page 23
(30 Aug 2009)

  • 21 CFR Part 2 - General Administrative Rulings and Decisions.

2.125 - Use of Ozone-depleting substances in foods, drugs, devise or cosmetics. Reintroduction of Epinephrine as a listed substance.
(08 Oct 2009)

  • 21 CFR 312 - Investigational New Drug Application

Changes to the rules relating to the charging for investigational drugs to allow a wider range of uses.
(13 Aug 2009)

312.140 - Technical Amendment to the address for sending IND applications.
(29 Oct 2009)

  • 21 CFR 73 - Listing of Color Additives Exempt from Certification.

37.352 - Addition of Paracoccus pigment.
(16 Nov 2009)

  • 21 CFR 862 - Clinical Chemistry ad Clinical Toxicology Devices

862.1163 - Introduction of new test - Cardiac Allograft gene expression profiling test system.
(21 Oct 2009)

  • 21 CFR 878 - General and Plastic Surgery Devices.
878.4015 - Introduction of new devices - Wound dressing with poly dially diethylamminoim chloride (pDADMAC) additive.

 

 

 

 

9th March 2009 (Database Update only)

The following regulations have been Added:

  • 21 CFR Part 864 - Hematology and Pathology Devices - Revised as of April 1, 2008
  • 21 CFR Part 884 - Obstetrical and Gynecological Devices - Revised as of November 10, 2008
  • 21 CFR Part 886 - Ophthalmic Devices - Revised as of June 23, 2008

The following regulations have been updated:

  • 21 CFR Part 314 - Applications For FDA Approval To Market A New Drug - Revised as of February 10, 2009
  • Eudralex Volume 4: Annex 1 (revised November 2008)
  • Eudralex Volume 4: Annex 3 (revised September 2008)

16th January 2009 (Database Update only)

The following regulations have been updated:

  • 21 CFR Part 314 - Applications For FDA Approval To Market A New Drug - Revised as of January 16, 2009
  • 21 CFR Part 320 - Bioavailability And Bioequivalence Requirements - Revised as of January 16, 2009
  • 21 CFR Part 56 - Institutional Review Boards - Revised as of January 15, 2009

5th January 2009 (Database Update only)

The following regulations have been updated:

  • 21 CFR Part 73 - Listing Of Color Additives Exempt From Certification - Revised as of January 5, 2009

12th January 2009 (Database Update only)

This release includes the following new regulations:

  • 21 CFR Part 882 - Neurological Devices - Revised as of April 1, 2008
  • 21 CFR Part 890 - Physical Medicine Devices - Revised as of April 1, 2008
  • 21 CFR Part 892 - Radiology Devices - Revised as of April 1, 2008

This database update includes updates to the following regulations:

  • 21st CFR Part 73 - Listing of Color Additives Exempt From Certification - Revised as of January 5, 2009
  • ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use In The ICH Regions - 1 November 2007
  • ICH Q4B Annex I: Evaluation and Recommendation of Pharmacopoeial Texts for Use In The ICH Regions 
    on Residue on Ignition/Sulphated Ash General Chapter - 1 November 2007
  • ICH Q8(R1): Pharmaceutical Development - 13 November 2008
  • Eudralex Volume 9A - Pharmacovigilance for Medicinal Products for Human Use (version April 2007)

15th December 2008 (Database Update only)

This release includes the following new regulations:

  • 21 CFR Part 1270 - Human Tissue Intended for Transplantation - Revised as of April 1, 2008
  • 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products - Revised as of April 1, 2008
  • ICH Q4B (Annex 4A): Evaluation and Recommendation of Pharmacopoeial Texts for use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests General Chapter - November 2008
  • ICH Q4B (Annex 4B): Evaluation and Recommendation of Pharmacopoeial Texts for use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms General Chapter - November 2008
  • ICH Q4B (Annex 4C): Evaluation and Recommendation of Pharmacopoeial Texts for the use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter - November 2008
  • ICH S8: Immunotoxicity Studies For Human Pharmaceuticals - September 2005

This database update includes the following draft regulations:

  • Eudralex Volume 4: Annex 1 (effective from 01 March 2009)
  • Eudralex Volume 4: Annex 3 (effective from 01 March 2009)
  • Eudralex Volume 4: Annex 7 (effective from 01 September 2009)
  • ICH E2B(R3) (Step 2)
  • ICH M3(R2) (Step 2)
  • ICH M5 (Step 2)
  • ICH Q4B Annex 5 (Step 2)
  • ICH Q4B Annex 6 (Step 2)
  • ICH Q4B Annex 7 (Step 2)
  • ICH Q4B Annex 8 (Step 2)
  • ICH Q8 Annex (Step 2)
  • ICH S2(R1) (Step 2)

Note: Pharmaceutical Administration and Regulations in Japan (March 2008) has been removed pending a usability assessment by our maintenance team.

Version 5.2 - December 2008

This release includes the following new functionality:

  • Introduction of a document repository to store user and company files. This provides the following options:
    • File upload - Uploading a file to the document repository through drag and drop functionality.
    • File Removal - Removing an uploaded file from the document repository.
    • File Management - Altering hierarchical file structure of uploaded documents.
    • Document Source - Documents displayed in both the original format and HTML. An option is provided to select viewing format.

The document repository will also contain the following three folders:

  • Draft Regulations - A storage space for draft regulations prior to release.
  • Guidelines - A selection of pharmaceutical and life science guidelines.
  • Templates - A selection of Quality documentation templates that can be used for project documentation.
  • Change Matrix - Provides the option of viewing regulatory additions, repeals and amendments.
  • Advanced Search - The document repository and sub folders can be included within the advanced search engine.
  • Tabbed Record Counts - A total record count from within cGARD and the document repository is displayed within the respective tabs in the left-hand menu. This also includes the total number of results returned after performing a search.

This release includes the following updated functionality:

  • The following options have been moved to the tools menu:
    • FDA Warning Letters - Searching and viewing FDA Warning Letters.
    • Regulatory Agencies - Links to Regulatory Agencies.
  • Updated help files to include new functionality.

This database update includes updates to the following regulations:

  • 21st CFR Part 1 - General Enforcement Regulations - Revised as of November 7, 2008
  • 21st CFR Part 2 - General Administrative Rulings and Decisions - Revised as of November 19, 2008
  • 21st CFR Part 17 - Civil Money Penalties Hearings - Revised as of November 12, 2008
  • 21st CFR Part 210 - Current good manufacturing practices in manufacturing, processing, packing or holding of drugs; general - Revised as of December 8, 2008
  • 21st CFR Part 211 - Current good manufacturing practises for finished pharmaceuticals - Revised as of December 8, 2008
  • 21st CFR Part 601 - Licensing - Revised as of November 18, 2008

This database update includes the following new FDA Guidelines:

  • Nuclear Pharmacy Guideline for Determining When to Register as a Drug Establishment (May 1984)
  • Safe Use of Handling of Cytotoxic Drugs
  • FDA - Compliance Policy Guides Manual (May 2002)
  • Possible Dioxin/PCB Contamination of Drug and Biological Products (August 2000)
  • Prescription Drug Marketing Act - Donation of Prescription Drug Samples to Free Clinics (March 2006)
  • Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (January 2006)
  • PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (September 2004)
  • CGMP for Phase 1 Investigational Drugs (July 2008)
  • Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (October 2007)
  • Compressed Medical Gases Guideline (February 1989)
  • Bar Code Label Requirements (October 2006)
  • Testing of Glycerin for Diethylene Glycol (May 2007)
  • Computerized Systems Used in Clinical Investigations (May 2007)
  • Quality Systems Approach to Pharmaceutical CGMP Regulations (September 2006)
  • The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP) (October 2007)
  • Marketed Unapproved Drugs - Compliance Policy Guide (June 2006)
  • A Review of FDA?s Implementation of The Drug Export Amendments of 1986 (May 1990)
  • Guideline For the Monitoring of Clinical Investigations (January 1988)
  • Guideline on Validation of the Limulus Amebocyte Lysate Test (December 1987)
  • Good Laboratory Practice Regulations - Questions and Answers (June 1981)
  • Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice (September 2004)
  • Part 11, Electronic Records; Electronic Signatures - Scope and Application (August 2003)
  • Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (October 2006)
  • Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (June 1997)
  • Cytotoxic Handling
  • Guideline on the Preperation of Investigational New Drug Products (Human and Animal) (March 1991)
  • Guideline On General Principles Of Process Validation (May 1987)

This database update includes the following draft regulations:

  • ICH E2F (Step 2)
  • ICH S9 (Step 2)
  • Eudralex Volume 4: Annex 11 (Draft)

 

 

 

15th October 2008 (Database Update only)

This database update includes the following new regulations:

  • 21st CFR Part 862 - Clinical chemistry and clinical toxicology devices - Revised as of April 1, 2008
  • 21st CFR Part 868 - Anesthesiology devices - Revised as of April 1, 2008
  • 21st CFR Part 870 - Cardiovascular devices - Revised as of April 1, 2008
  • 21st CFR Part 872 - Dental devices - Revised as of April 1, 2008
  • 21st CFR Part 876 - Gastroenterology-urology devices - Revised as of April 1, 2008
  • 21st CFR Part 878 - General and plastic surgery devices - Revised as of April 1, 2008
  • 21st CFR Part 880 - General hospital and personal use devices - Revised as of April 1, 2008
  • 21st CFR Part 1311 - Digital Certificates - Revised as of April 1, 2008
  • DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices

This database update also includes updates to the following regulations:

  • 21 CFR Part 16 - Regulatory Hearing Before the Food and Drug Administration - Revised as of April 1, 2008
  • 21 CFR Part 111 - 21st Code of Federal Regulations Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements - Revised as of April 1, 2008
  • 21 CFR Part 203 (US PDMA) - Prescription drug marketing - Revised as of April 1, 2008
  • 21 CFR Part 210 (US GMP) - Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general - Revised as of April 1, 2008
  • 21 CFR Part 312 (US GCP) - Investigational new drug application - Revised as of April 1, 2008
  • 21 CFR Part 314 (US GCP) - Applications for FDA approval to market a new drug - Revised as of April 1, 2008
  • 21 CFR Part 600 (US Biologics) - Biological products - General - Revised as of April 1, 2008
  • 21 CFR Part 610 (US Biologics) - General biological products standards - Revised as of April 1, 2008
  • 21 CFR Part 610 (US Biologics) - General biological products standards - Revised as of April 1, 2008
  • 21 CFR Part 640 - Additional Standards for Human Blood and Blood Products - Revised as of April 1, 2008
  • 21 CFR Part 700 - Cosmetics General - Revised as of April 1, 2008
  • 21 CFR Part 800 - General - Revised as of April 1, 2008
  • 21 CFR Part 801 - Labeling - Revised as of April 1, 2008
  • 21 CFR Part 803 - Medical Device Reporting - Revised as of April 1, 2008
  • 21 CFR Part 808 - Exemptions from Federal Preemption of State And Local Medical Device Requirements - Revised as of April 1, 2008
  • 21 CFR Part 812 (US Devices) - Investigational device exemptions - Revised as of April 1, 2008
  • 21 CFR Part 814 (US Devices) - Pre-market approval of medical devices - Revised as of April 1, 2008
  • 21 CFR Part 821 - Medical device tracking requirements - Revised as of April 1, 2008
  • 21 CFR Part 860 - Medical Device Classification Procedures - Revised as of April 1, 2008

Version 5.1.2 - September 2008

This release includes the following updated functionality:

  • Ultra-fast search capability
  • Introduction of % (percent) wildcards in all searches (replaces Match Whole Word checkboxes)

Version 5.1.1 - August 2008

This release includes the following updated functionality:

  • Cycle record buttons have been moved to bottom-left of screen, entitled prev and next
  • Menu display and screen resize bugs fixed
  • Improved look-and-feel

This release includes the following new regulations:

  • Directive 89/105/EEC - Relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems
  • Directive 2007/47/EC - Amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
  • Directive 2008/29/EC - Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission
  • 21 CFR Part 12 - Formal Evidentiary Public Hearing - Revised as of April 1, 2008
  • 21 CFR Part 13 - Public Hearing Before a Public Board Of Inquiry - Revised as of April 1, 2008
  • 21 CFR Part 14 - Public Hearing Before a Public Advisory Committee - Revised as of April 1, 2008
  • 21 CFR Part 15 - Public Hearing Before the Commissioner - Revised as of April 1, 2008
  • 21 CFR Part 16 - Regulatory Hearing Before the Food and Drug Administration - Revised as of April 1, 2008
  • 21 CFR Part 17 - Civil Money Penalties Hearings - Revised as of April 1, 2008
  • 21 CFR Part 607 - Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products - Revised as of April 1, 2008
  • 21 CFR Part 630 - General Requirements for Blood, Blood Components and Blood Derivatives - Revised as of April 1, 2008
  • 21 CFR Part 640 - Additional Standards for Human Blood and Blood Products - Revised as of April 1, 2008
  • 21 CFR Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests - Revised as of April 1, 2008
  • 21 CFR Part 680 - Additional Standards for Miscellaneous Products - Revised as of April 1, 2008
  • 21 CFR Part 700 - Cosmetics General - Revised as of April 1, 2008
  • 21 CFR Part 701 - Cosmetic Labeling - Revised as of April 1, 2008
  • 21 CFR Part 710 - Voluntary Registration of Cosmetic Product Estalishments - Revised as of April 1, 2008
  • 21 CFR Part 720 - Voluntary Filing of Cosmetic Product Ingredient Composition Statements - Revised as of April 1, 2008
  • 21 CFR Part 740 - Cosmetic Product Warning Statements - Revised as of April 1, 2008
  • 21 CFR Part 800 - General - Revised as of April 1, 2008
  • 21 CFR Part 801 - Labeling - Revised as of April 1, 2008
  • 21 CFR Part 803 - Medical Device Reporting - Revised as of April 1, 2008
  • 21 CFR Part 806 - Medical Devices; Reports of Corrections and Removals - Revised as of April 1, 2008
  • 21 CFR Part 808 - Exemptions from Federal Preemption of State And Local Medical Device Requirements - Revised as of April 1, 2008
  • 21 CFR Part 809 - In Vitro Diagnostic Products for Human Use - Revised as of April 1, 2008
  • 21 CFR Part 810 - Medical Device Recall Authority - Revised as of April 1, 2008
  • 21 CFR Part 860 - Medical Device Classification Procedures - Revised as of April 1, 2008
  • 21 CFR Part 1300 - Definitions - Revised as of April 1, 2008
  • 21 CFR Part 1301 - Registration of manufacturers, distributors, and dispensers of controlled substances - Revised as of April 1, 2008
  • 21 CFR Part 1302 - Labeling and packaging requirements for controlled substances - Revised as of April 1, 2008
  • 21 CFR Part 1303 - Quotas - Revised as of April 1, 2008
  • 21 CFR Part 1304 - Records and reports of registrants - Revised as of April 1, 2008
  • 21 CFR Part 1305 - Orders for schedule I and II controlled substances - Revised as of April 1, 2008
  • 21 CFR Part 1306 - Prescriptions - Revised as of April 1, 2008
  • 21 CFR Part 1307 - Miscellaneous - Revised as of April 1, 2008
  • 21 CFR Part 1308 - Schedules of controlled substances - Revised as of April 1, 2008
  • 21 CFR Part 1309 - Registration of manufacturers, distributors, importers and exporters of List I chemicals - Revised as of April 1, 2008
  • 21 CFR Part 1310 - Records and reports of listed chemicals and certain machines - Revised as of April 1, 2008
  • 21 CFR Part 1312 - Importation and exportation of controlled substances - Revised as of April 1, 2008
  • 21 CFR Part 1313 - Importation and exportation of List I and List II chemicals - Revised as of April 1, 2008
  • 21 CFR Part 1314 - Retail sale of scheduled listed chemical products - Revised as of April 1, 2008
  • 21 CFR Part 1315 - Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine - Revised as of April 1, 2008
  • 21 CFR Part 1316 - Administrative functions, practices, and procedures - Revised as of April 1, 2008

This release includes updates to the following regulations:

  • All 21 CFRs (revised April 1, 2008)
  • Eudralex Volume 4: Part I (revised February 2008)

Version 5.1 - July 2008

This release includes the following new Regulatory Intelligence Portal features:

  • Search for FDA Warning Letters
  • Regulatory News Feeds
  • User Password Management

Includes the following new regulations:

  • 21 CFR Part 26 - Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and certain Medical Device Product Evaluation Reports: UNITED STATES and the EUROPEAN COMMUNITY
  • 21 CFR Part 111 - Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
  • 21 CFR Part 205 - Guidelines for State licensing of wholesale prescription drug distributors
  • 21 CFR Part 206 - Imprinting of solid oral dosage form drug products for human use
  • 21 CFR Part 208 - Medication Guides for prescription drug products
  • 21 CFR Part 216 - Pharmacy compounding
  • 21 CFR Part 225 - Current good manufacturing practice for medicated feeds
  • 21 CFR Part 320 - Bioavailability and bioequivalence requirements
  • 21 CFR Part 328 - Over-the-counter drug products intended for oral ingestion that contain alcohol
  • 21 CFR Part 330 - Over-the-counter (OTC) human drugs which are generally recognized as safe and effective and not misbranded
  • 21 CFR Part 331 - Antacid products for over-the-counter (OTC) human use
  • 21 CFR Part 332 - Antiflatulent products for over-the-counter human use
  • 21 CFR Part 333 - Topical antimicrobial drug products for over-the-counter human use
  • 21 CFR Part 336 - Antiemetic drug products for over-the-counter human use
  • 21 CFR Part 338 - Nighttime sleep-aid drug products for over-the-counter human use
  • 21 CFR Part 340 - Stimulant drug products for over-the-counter human use
  • 21 CFR Part 341 - Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use
  • 21 CFR Part 343 - Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use
  • 21 CFR Part 344 - Topical OTIC drug products for over-the-counter human use
  • 21 CFR Part 346 - Anorectal drug products for over-the-counter human use
  • 21 CFR Part 347 - Skin protectant drug products for over-the-counter human use
  • 21 CFR Part 348 - External analgesic drug products for over-the-counter human use
  • 21 CFR Part 349 - Ophthalmic drug products for over-the-counter human use

 

 

 

  • 21 CFR Part 352 - Sunscreen drug products for over-the-counter human use
  • 21 CFR Part 355 - Anticaries drug products for over-the-counter human use
  • 21 CFR Part 357 - Miscellaneous internal drug products for over-the-counter human use
  • 21 CFR Part 358 - Miscellaneous external drug products for over-the-counter human use
  • 21 CFR Part 361 - Prescription drugs for human use generally recognized as safe and effective and not misbranded: Drugs used in research
  • 21 CFR Part 369 - Interpretative statements re warnings on drugs and devices for over-the-counter sale
  • Polish Pharmaceutical Law - Legal status valid 5th July 2006
  • Eudralex Volume 9A of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use
  • Eudralex Volume 9B of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance of Veterinary Medicinal Products
  • ICH Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter
  • ICH Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter
  • ICH E14 Q and A: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs - 4th June 2008

Updates the Following Regulations:

  • ICH Q4B: Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) - November 2007
  • ICH Q4B (Annex 1): Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC) - November 2007
  • ICH Q10: Draft Consensus Guideline Pharmaceutical Quality System - June 2008
  • ICH S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals limit Dose - March 2008

Version 5.0 - May 2008

Web-based application release, secured with 128-bit SSL encryption.

Version 4.2 - April 2008

Includes the following new regulations:

  • 21 CFR Part 10 - Administrative Practices and Procedures
  • 21 CFR Part 19 - Standards of Conduct and Conflicts of Interest
  • 21 CFR Part 20 - Public Information
  • 21 CFR Part 21 - Protection of Privacy
  • 21 CFR Part 25 - Environmental Impact Considerations
  • 21 CFR Part 60 - Patient Term Restoration
  • 21 CFR Part 70 - Color Additives
  • 21 CFR Part 71 - Color Additive Petitions
  • 21 CFR Part 73 - Listing of Color Additives Exempt From Certification
  • 21 CFR Part 74 - Listing of Color Additives Subject to Certification
  • 21 CFR Part 80 - Color Additive Certification
  • 21 CFR Part 81 - General Specifications and General Restrictions for Provisional Color Additives for use in Foods, Drugs, And Cosmetics
  • 21 CFR Part 82 - Listing of Certified Provisionally Listed Colors and Specifications
  • 21 CFR Part 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
  • 21 CFR Part 201 - Labeling
  • 21 CFR Part 202 - Prescription Drug Advertising
  • 21 CFR Part 207 - Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
  • 21 CFR Part 290 - Controlled Drugs
  • 21 CFR Part 250 - Special Requirements for Specific Human Drugs
  • 21 CFR Part 299 - Drugs; Official Names and Established Names
  • 21 CFR Part 300 - General
  • 21 CFR Part 310 - New Drugs
  • 21 CFR Part 315 - Diagnostic Radiopharmaceuticals
  • 21 CFR Part 316 - Orphan Drugs
  • 21 CFR Part 895 - Banned Devices
  • 21 CFR Part 1401 - Public Availability of information
  • 21 CFR Part 1402 - Mandatory declassification review
  • 21 CFR Part 1403 - Uniform? administrative requirements for grants and cooperative agreements to state and local governments
  • 21 CFR Part 1404 - Governmentwide debarment and suspension (Nonprocurement)
  • 21 CFR Part 1405 - Governmentwide requirements for drug-free workplace (Financial Assistance)
  • Eudralex Volume 4: Annex 20 - Quality Risk Management
  • Pharmaceutical Administration and Regulations in Japan English Regulatory Information Task Force, Japan: Pharmaceutical Manufacturers Association - March 2006
  • S.I. 2005-2753 - Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 - October 2005
  • S.I. 2005-2753 - Explanatory Note - October 2005
  • S.I. 2005-2753 (Schedule 5) - Procedural Provisions Relating to the Grant Renewal, Variation, Revocation and Suspension of Certificates of Registration - October 2005
  • S.I. 2005-2753 (Schedule 6) - Offences, Penalties etc. - October 2005
  • S.I. 2005-2753 (Schedule 7) - Transitional Provisions - October 2005
  • S.I. 2005-2753 (Schedule) - Consequential Amendments of the Act and Other Regulations - October 2005

Updates the Following Regulations:

  • Updates to all 21 CFR regulations (revised on 1st April 2007)

Version 4.1 - January 2008

Includes the following new regulations:

  • Drug Administration Law of the Peoples Republic of China
  • Regulations for Implementation of the Drug Administration Law of the Peoples Republic of China
  • Regulations for Supervision and Administration of Medical Devices
  • Regulations on Administrative Protection for Pharmaceuticals
  • S.I. 2005/2789 - The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005
  • S.I. 2005/2789 (Schedule 1) - STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE MANUFACTURE AND ASSEMBLY OF RELEVANT MEDICINAL PRODUCTS
  • S.I. 2005/2789 (Schedule 2) - STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE RELATING TO THE IMPORT OF RELEVANT MEDICINAL PRODUCTS FROM A THIRD COUNTRY
  • S.I. 2005/2789 (Schedule 3) - STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO VACCINES, TOXINS OR SERA
  • S.I. 2005/2789 (Schedule 4) - STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A WHOLESALE DEALER'S LICENCE
  • S.I. 2005/2789 (Schedule 5) - CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS
  • S.I. 2005/2789 (Schedule 6) - TRANSITIONAL PROVISIONS
  • ICH E1 - The Extent of Population Exposure to Assess Clinical Safety
  • ICH E2B Q&A(R5) - (ver.1.1) March 2005
  • ICH E2B(R3) - REVISION of the Clinical Safety Data Management
  • ICH E2C(R1) - Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
  • ICH E2D - Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
  • ICH E2E - Pharmacovigilance Planning
  • ICH E3 - Structure and Content of Clinical Study Reports
  • ICH E4 - Dose-Response Information to Support Drug Registration
  • ICH E5 Q&A(R1) - June 2006
  • ICH E5(R1) - Ethnic Factors in the Acceptability of Foreign Clinical Data
  • ICH E7 - Studies in support of Special Populations: Geriatrics
  • ICH E8 - General Considerations for Clinical Trials
  • ICH E9 - Statistical Principles for Clinical Trials
  • ICH E10 - Choice of Control Group in Clinical Trials
  • ICH E11 - Clinical Investigation of Medicinal Products in the Pediatric Population
  • ICH E12A - Principles for Clinical Evaluation of New Antihypertensive Drugs
  • ICH E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
  • ICH E15 - Terminology in Pharmacogenomics
  • ICH M1 - MedDRA - Medical Terminology
  • ICH M2(R2) - Electronic Transmission of Individual Case Safety Reports Message Specification
  • ICH M3(R1) - Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
  • ICH M4(R3) - Organisation Of The Common Technical Document For The Registration Of Pharmaceuticals For Human Use
  • ICH M4E(R1) - The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Efficacy
  • ICH M4Q(R1) - The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Quality
  • ICH M4S(R2) - The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Safety
  • ICH M5 - Data Elements And Standards For Drug Dictionaries
  • ICH Q1A(R2) - Stability Testing of New Drug Substances and Products
  • ICH Q1B - Stability Testing : Photostability Testing of New Drug Substances and Products
  • ICH Q1C - Stability Testing for New Dosage Forms
  • ICH Q1D - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
  • ICH Q1E - Evaluation of Stability Data
  • ICH Q1F - Stability Data Package for Registration Applications in Climatic Zones III and IV
  • ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology
  • ICH Q4 - Pharmacopoeias
  • ICH Q4A - Pharmacopoeial Harmonisation
  • ICH Q4B - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
  • ICH Q4B (Annex 1) - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
  • ICH Q6A (Decision Trees)
  • ICH Q10 - Pharmaceutical Quality System
  • ICH S1A - Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
  • ICH S1B - Testing for Carcinogenicity of Pharmaceuticals
  • ICH S1C(R1) - Dose Selection for Carcinogenicity Studies of Pharmaceuticals
  • ICH S2A - Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
  • ICH S2B - Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
  • ICH S3A - Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
  • ICH S3B - Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
  • ICH S4 - Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent)

 

 

 

  • ICH S5(R2) - Detection of Toxicity to Reproduction for Medicinal Products
  • ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
  • ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals
  • ICH S7B - The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization

Updates the Following Regulation:

  • ICH Q3A(R1) - Impurities in New Drug Substances

Version 4.0 - October 2007

Updates The Following Regulations:

  • 21 CFR Part 606 (US Biologics) - current Good Manufacturing Practice for Blood and Blood Components
  • 21 CFR Part 610 (US Biologics) - General biological products standards

This release contains the following new functionality:

  • Automatic regulatory database updates
  • Regulations added or amended are highlighted
  • Glossary database of regulatory, pharmaceutical and life-science terminology
  • Advanced search function
  • Streamlined user interface
  • Regulatory assessment reports
  • Links to global regulatory agencies

Version 3.5 - July 2007

Includes the following new regulations:

  • Directive 2004-23-EC - Standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
  • Directive 2002-98-EC - Amending Directive 2001/83/EC.
  • Directive 2004-24-EC - Amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
  • Directive 2004-27-EC - Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).
  • Directive 2003-63-EC - Amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use.

Version 3.4 - April 2007

Includes the following new regulations:

  • Directive 2001/95/EC - General Product Safety

Updates The Following Regulations:

  • 21 CFR Part 1 - General enforcement regulations
  • 21 CFR Part 50 (US GCP) - Protection of human subjects
  • 21 CFR Part 210 (US GMP) - Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general
  • 21 CFR Part 226 - Current good manufacturing practice for type a medicated articles
  • 21 CFR Part 312 (US GCP) - Investigational new drug application
  • 21 CFR Part 807 - Establishment registration and device listing for manufacturing and initial importers of devices
  • 21 CFR Part 812 (US Devices) - Investigational device exemptions
  • 21 CFR Part 814 (US Devices) - Pre-market approval of medical devices

Version 3.3 - January 2007

Includes the following new regulations:

  • 21 CFR Part 1- General enforcement regulations
  • 21 CFR Part 2 - General administrative rulings and decisions
  • 21 CFR Part 3- Product jurisdiction
  • 21 CFR Part 5 - Organisation
  • 21 CFR Part 7- Enforcement policy
  • 21 CFR Part 200- General
  • 21 CFR Part 807- Establishment registration and device listing for manufacturing and initial importers of devices
  • 21 CFR Part 821 - Medical device tracking requirements
  • 21 CFR Part 861 - Procedures for performance standards development
  • ICH E6(R1) - Guidelines for Good Clinical Practice
  • GDP 94-C 63-03 - Guidelines on Good Distribution Practice of Medicinal Products for Human Use

Version 3.2 - October 2006

Includes the following new regulations:

  • ICH Q5A(R1) - Viral Safety Evaluation Of BioTechnology Products Derived From Cell Lines Of Human Or Animal Origin
  • ICH Q5B - Quality Of BioTechnical Products
  • ICH Q5C - Stability testing Of BioTechnological/Biological Products
  • ICH Q5D - Production Of BioTechnological/Biological Products
  • ICH Q5E - Comparability Of BioTechnological/Biological Products Subject To Changes In Their Manufacturing Process
  • ICH Q8 - Pharmaceutical Development
  • EU 178/2002 - Directive laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
  • EU 1935/2004 - materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC
  • EU 2005/28EC - principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use
  • EU 93/42/EEC - 14 June 1993 concerning medical devices
  • EU 2001/83/EC - Community code relating to medicinal products for human use
  • EU 2002/95/EC - Restrictions of the use of hazardous substances in electrical and electronic equipment
  • EU 2002/96/EC - Where a computerised system replaces a manual operation
  • SOR/98-282 - Medical Devices Regulations

Version 3.1 - July 2006

Database update with amendments and a



     
     

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