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David A. Dodd to Lead BioReliance Corporation
David A. Dodd has joined BioReliance as the Company's President, Chief Executive Officer and Chairman of the Board, effective December 3, 2007. From 2000 through 2006, Mr. Dodd served as President and CEO of Serologicals Corporation, a publicly traded company that was sold to Millipore Corporation in 2006 for $1.4 billion. Prior to that, from 1995 Mr. Dodd was President and CEO of Solvay Pharmaceuticals, Inc.
Click here to read the press release.
David L. Bellitt joins Bioreliance David L. Bellitt has been named Vice President of Global Commercial Operations, Biologics. Mr. Bellitt will be responsible for all global commercialization activities, including sales, marketing and customer service. He will also serve as a member of the Corporate Operating Committee.
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BioReliance Corporation Launches iNet™ for Online Results Tracking of Biological Safety Tests BioReliance is pleased to announce to US customers the release of iNet, a proprietary information technology system for submitting and tracking test article details via a controlled and secure Internet access from any location worldwide. Now you can view the status of current and past studies, keep informed of when testing will be completed, download reports, and allow your colleagues to view the status of your tests.
Click here to read the press release.

This page provides access to regulatory guidance and other resources that are generally available from web sites operated and maintained by other organisations.

European Medicines Agency (EMEA) Guidelines

Documents which have been considered by the Committee for Human Medicinal Products or the Committee for Veterinary Medicinal Products, in consultation with the European commission and the competent authorities of the Member States, to assist applicants for a marketing authorisation.

New regulatory guidance and other resources for toxicology are now available.

DOCUMENT TITLE* *Note: these links take you directly to the documents on the EMEA web site. Please let us (info@bioreliance.com) know if you have problems accessing them.	DOCUMENT TYPE	DATE POSTED on this web site
Concept Paper on the Development of a CHMP Guideline on Non-Clinical Testing for Inadvertent Germline Transmission of Gene Transfer Vectors EMEA/CPMP/SWP/110180/04	Concept Paper	June 2005
Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certification EMEA/CPMP/4548/03/Final/Rev 1	Guideline (Revised)	June 2005
Guideline on Active Substance Master File Procedure EMEA/CVMP/134/02 Rev 1 Further information	Guideline	June 2005
Report from the CHMP Gene Therapy Expert Group Meeting 14, 15 October 2005 EMEA/CHMP/183989/2004 Further information	Group Meeting Report	June 2005
Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Quality Issues EMEA/CHMP/49348/05 (CHMP released for consultation March 2005) Further information	Guideline	June 2005
Guideline on Similar Biological Medicinal Products CPMP/437/04 (Released for consultation by CHMP November 2004) Further information	Guideline	February 2005
Similar Biological Medicinal Products containing Recombinant Granulocyte-Colony Stimulation Factor - Annex to the Guideline for the Development of Similar Biological Medicinal Products containing Biotechnology Derived Proteins as Active Substance (non) Clinical Issues CHMP/146701/2004 (Released for consultation by CHMP November 2004)	Concept Paper	February 2005
Similar Biological Medicinal Products containing Recombinant Human Insulin - Annex to the Guideline for the Development of Similar Biological Medicinal Products containing Biotechnology Derived Proteins as Active Substance (non) Clinical Issues CHMP/146710/2004 (Released for consultation by CHMP November 2004)	Concept Paper	February 2005
Similar Biological Medicinal Products containing Recombinant Human Erythropoietin - Annex to the Guideline for the Development of Similar Biological Medicinal Products containing Biotechnology Derived Proteins as Active Substance (non) Clinical Issues CHMP/146664/2004 (Released for consultation by CHMP November 2004)	Concept Paper	February 2005
Similar Biological Medicinal Products containing Recombinant Human Growth Hormone - Annex to the Guideline for the Development of Similar Biological Medicinal Products containing Biotechnology Derived Proteins as Active Substance (non) Clinical Issues CHMP/146489/2004 (Released for consultation by CHMP November 2004)	Concept Paper	February 2005
Concept Paper on the Development of a Guideline on Viral Safety Evaluation of Biotechnological Products to be used in Clinical Trials CHMP/BWP/124447/04 (Released for consultation December 2004)	Concept Paper	February 2005
ICH Q5E Comparability of Biotechnical/Biological Products – Note for Guidance on Biotechnical/Biological Products Subject to changes in their manufacturing process (Step 4) CPMP/ICH/5721/03 (Final approval by CHMP December 2004, comes into operation June 2005)	Note for Guidance	February 2005
Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical Trials CHMP/QWP/185401/04 (Released for consultation December 2004, deadline for comments June 2005)	Guideline	February 2005
ICH Q8 Pharmaceutical Development – Note for Guidance on Pharmaceutical Development (Step 2) EMEA/CHMP/167068/04 (Released for 6 months consultation, transmission to Interested Parties December 2004, deadline for comments June 2005)	Note for Guidance	February 2005
Guideline on Adjuvants in Vaccines for Human Use EMEA/CHMP/VEG/134716/2004 (CHMP Adopted January 2005, coming into operation July 2005)	Guideline	February 2005
Core SPC for Pandemic Influenza Vaccines EMEA/CHMP/VEG/193031/2004/draft (Released for consultation January 2005)	Draft Guideline	February 2005
Guideline on Live Recombinant Vector Vaccines for Veterinary Use EMEA/CVMP/004/04 (CVMP adopted December 2004) Further information	Veterinary Guidance	February 2005
Target Animal Safety: Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence CVMP/VICH/1052/2004-CONSULTATION Further information	Draft Guideline	February 2005
Concept Paper on the need to Revise the Guideline on Production and Quality Control of Monoclonal Antibodies CHMP/BWP/64/04 (3AB4A, Revision December 1994) (Released for consultation November 2004)	Concept Paper	February 2005
Guideline on the Investigation of Manufacturing Processes for Plasma-Derived Medicinal Products with Regard to VCJD risk CPMP/BWP/CPMP/5136/03 (CHMP adopted October 2004)	Guideline	February 2005
Guideline on Assessing the Risk For Virus Transmission – New Chapter 6 of the Note for Guidance on Plasma-Derived Medicinal Products CPMP/BWP/269/95, CPMP/BWP/5180/03 (CHMP adopted October 2004)	Guideline	February 2005
Consolidated version of the EU Human Code for Medicinal Products Consolidated version of Directive 2001/83/EC	EU Directive	Sept 2004
Consolidated version of the EU Veterinary Code for Medicinal Products Consolidated version of Directive 2001/82/EC	EU Directive	Sept 2004
Position Statement on Creutzfeldt-Jakob disease and Plasma-derived and Urine-derived Medicinal Products EMEA/CPMP/BWP/2879/02/Rev.1 Further information	Position Statement	Sept 2004
Guideline on Requirements and Controls Applied to Bovine Serum Used in the Production of Immunological Veterinary Medicinal Products EMEA/CVMP/743/00/Rev.1/consultation Deadline for comments to EMEA - Jan 2005	Note for Guidance (Veterinary)	Sept 2004
Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products CVMP/VICH/811/04-Consultation Deadline for comments to EMEA - Feb 2005	VICH Guideline, VICH Topic GL40 Step 4 Specifications	Sept 2004
Risk assessment of Ruminant Materials Originating from USA and Canada EMEA/CHMP/BWP/27/04 Further information	EMEA position paper	Sept 2004
Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products EMEA/410/01 Rev. 3 Further information	Draft Note for Guidance	June 2004
Concept Paper on the Development of a CHMP revised Guideline on Clinical Evaluation of New Vaccines CHMP/VEG/1820/04	Concept Paper (Vaccines)	June 2004
Conclusions and Recommendations with Regard to the Use of Genetically Modified Animal Models for Carcinogenicity Assessment CPMP/SWP/2592/04 Rev 1	Recommendations	June 2004
Guideline on the Limits of Genotoxic Impurities CPMP/SWP/5199/02	Guideline for Consultation	June 2004
Position Paper on Requirements for Vaccines against Foot-and-Mouth Disease EMEA/CVMP/775/02 - FINAL	Position Paper (Veterinary)	June 2004 (effective Dec 04)
Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application CPMP/VEG/4717/03	Guideline (Vaccines)	April 2004
Guideline on Requirements for Plasma Master File (PMF) Certification CPMP/BWP/4663/03	Guideline	April 2004
Guideline on Stability Testing for Applications for Variation to a Marketing Authorisation CPMP/QWP/576/96-rev 1 - consultation EMEZ/CVMP/373/04 - consultation	Guideline	April 2004
Concept Paper on the Development of a CPMP Guideline on the Requirements to the Quality Part of a Request for Authorisation of a Clinical Trial CPMP/QWP/1542/04	Concept paper	April 2004
Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certification EMEA/CPMP/4548/03/Final	Guideline (Vaccines)	March 2004
Guideline on the Scientific Data Requirements for a Vaccine Antigen Master File (VAMF) EMEA/CPMP/BWP/3734/03	Guideline (Vaccines)	March 2004
Guideline on Adjuvants in Vaccines EMEA/CPMP/VEG/17/03/2004v5/Consultation	Guideline (Vaccines)	March 2004
Position Paper/Guideline on the Toxicokinetic Evaluation of Control Samples in Toxicology Studies EMEA/CPMP/SWP/1094/04/corr	Draft Guideline	March 2004
Guideline on Live Recombinant Vector Vaccines for Veterinary Use Draft EMEA/CVMP/004/04 Consultation Further information	Draft Guideline	March 2004
Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance (Non-Clinical and Clinical) – Guidance Adopted EMEA/CPMP/BWP/3097/02 Final Further information	Note for Guidance	March 2004
Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance (Quality) – Revision Adopted EMEA/CPMP/BWP/3207/00 Rev 1 Further information	Note for Guidance	March 2004
Points to Consider on Xenogeneic Cell Therapy Medicinal Products – Final Guidance Adopted Final Guidance Adopted CPMP/1199/02 Further information	Points to consider	March 2004
EMEA ICH Topic Q5EB, Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Further information	Note for Guidance	December 2003
CPMP BWP Discussion Paper on Plasma and vCJD CPMP/BWP/5136/03 Further information	Position statement	December 2003
EMEA CPMP Note for Guidance on Viral Risks, Agents CPMP/BWP/5180/03 Further information	Points to consider	November 2003
Points to consider on xenogeneic cell therapy medicinal products CPMP/1199/02 Further information	Points to consider	August 2003
Points To Consider On Development Of Live Attentuated Influenza Vaccines CPMP/BWP/2289/01 Further information	Points to consider	August 2003
EMEA CPMP Position Statement on West Nile Virus and Plasma-Derived Medicinal Products CPMP/BWP/3752/03 Further information	Position Statement	August 2003
Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products CPMP/BWP/1793/02 Further information	Note for Guidance	August 2003
Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathies via Human and Veterinary Medical Products EMEA/410/01 Rev. 2. Further information	Note for Guidance	August 2003
Note for guidance on development of vaccinia virus based vaccines against smallpox CPMP/1100/02 Further information	Note for Guidance	August 2002
Revision of note for guidance on quality of water for pharmaceutical use CPMP/QWP/158/01 Revision and EMEA/CVMP/115/01 Further information	Note for Guidance	August 2002
Risk assessment on use of lactose prepared by using calf rennet CPMP/BWP/337/02 Further information	CPMP/BWP	August 2002
Note for Guidance on the Production and Quality Control of Animal Immunoglobins and Immunosera for Human Use CPMP/BWP/3354/99 Further information	Note for Guidance	August 2002
Draft Note for Guidance on the comparability of medicinal products containing biotechnology-derived proteins as drug substance CPMP/3097/02 - Annex Further information	Draft Note for Guidance	August 2002
Points to consider on the quality aspects of medicines containing active substances produced by transgenic plants - draft CPMP/BWP/764/02 Further information	Points to Consider	June 2002
Position statement on testing for SV40 in poliovirus vaccines CVMP/BWP/1412/02 Further information	CPMP/BWP	June 2002
Concept paper on the development of a note for guidance on requirements for the evaluation of new adjuvants in vaccines CPMP/BWP/6622/02 Further information	CPMP/BWP	June 2002
CVMP Public Statement on CPMP Public Statement on Lactose Prepared Using Calf Rennet and BSE EMEA/CVMP/556/02 Further Information	Public Statement	June 2002
EMEA releases VICH document on detection of mycoplasma for public comment CVMP/VICH/463/02 - Consultation Further Information	VICH Document	June 2002
Lactose Prepared with Calf Rennet: Risk Assessment in Relationship to Bovine Spongiform Encephalopathies (BSE) EMEA/CPMP/571/02 Further information	Public Statement	Feb 2002
Cell Culture Inactivated Influenza Vaccines CPMP/BWP/2490/00 Adopted Further information	Note for Guidance	Jan 2002
Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Active Substance* CPMP/BWP/3207/00 Further information	Note for Guidance	2001
Control of Starting Materials for the Production of Plasma-Derived Medicinal Products* CPMP/BWP/2053/01 draft – III/5272/94 rev 1 Further information	CPMP/BWP	2001
EMEA Guidance - New Notice to Applicants (Eudralex Vol 2B) - format for Common Technical Document (CTD)* Further information	Note for Guidance	2001
Points to consider on Human Somatic Cellular Therapy Medicinal Products* CPMP/BWP/41450/98 Further information	Points to Consider	2001
EMEA expert workshop on human TSE’s and plasma derived medicinal products, adopted* CPMP/BWP/3088/99 Further information	Note for Guidance	2001
Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agent via Human and Veterinary Medicinal Products* EMEA/410/01 - Rev 1 Further information	Note for Guidance	2001
The use of Tumourigenic cells of human origin for the production of Biological and Biotechnological Medicinal Products* CPMP/BWP/1143/00 Further information	CPMP/BWP Position paper	2001
Process Validation* CPMP/QWP/848/96 – EMEA/CVMP/598/99 Further information	Note for Guidance	2001
Plasma derived medicinal products* CPMP/BWP/269/95 Rev 3	Note for Guidance (revision)	2001
Position Paper on Risk Assessment of the Use of Starting Materials of Ruminant Origin* EMEA/CVMP/201/01 Further information	CVMP Position paper	2001
Position Paper on Risk of Transmission of Animal Spongiform Encephalopathy Agents* EMEA/CVMP/019/01 Further information	CVMP Position paper	2001
EMEA workshop on Application to pharmaceuticals of Assays for Markers of TSEs*	Workshop report	1999
New variant CJD and plasma-derived medicinal products*	CPMP Position Statement	1998
Safety Study for gene therapy products*	Annex to Note for Guidance	1998
Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating The Inactivation and Removal of Viruses*	Note for Guidance	1996
Gene Therapy products - Quality Aspects on the Production of Vectors and Genetically Modified Somatic Cells*	Note for Guidance	1995
Production and Quality Control of Monoclonal Antibodies (Revision)*	Note for Guidance	1995
Production and Quality Control of Medicinal Products Derived by Recombinant DNA Technology*	Note for Guidance	1995
TOXICOLOGY
ICH S8 Immunotoxicity studies for Human Pharmaceuticals – Note for Guidance on Immunotoxicity Studies for Human Pharmaceuticals (Step 2) EMEA/CHMP/167235/2004	Note for Guidance	June 2005
Reflection paper on the Assessment of the Genotoxic Potential of Antisense Oligodeoxynucleotides CHMP/SWP/199726/2004	Reflection Paper	February 2005
ICH S8 Immunotoxicity studies for Human Pharmaceuticals – Note for Guidance on Immunotoxicity Studies for Human Pharmaceuticals (Step 2) EMEA/CHMP/167235/2004 (Released for 4 months consultation, transmission to Interested Parties December 2004)	Note for Guidance	February 2005
Concept Paper on the Development of a CHMP Guideline on Non-Clinical Testing for Inadvertent Germline Transmission of Gene Transfer Vectors CPMP/SWP/110180/2004	Concept Paper	February 2005

IMPORTANT NOTICE
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