EMEA 生物学的製剤ガイダンスリスト
Workplan
General reporting
Concept papers
Point to consider
Draft guidelines
Approved guidelines
Workplan
General Reporting
EMEA/BWP/111233/05 EU Recommendations for the Influenza Vaccine Composition for the Season
2005/2006
EMEA/CHMP/BWP/27/04 First Cases of BSE in USA and Canada: Risk assessment of Ruminant
Materials Orgination from USA and Canada
EMEA/BWP/1104/04 EU Recommendations for the Influenza Vaccine Composition for the Season
2004/2005
CPMP/BWP/3752/03 Position Statement on West Nile Virus and Plasma-Derived Medicinal Products
CPMP/BWP/6011/03 Final EU Recommendation for Influenza Vaccine Composition for the Season
2003/2004
EMEA/CPMP/BWP/1818/02 Final CPMP Position Statement on Non-Remunerated and Remunerated
Donors: Safety and Supply of Plasma-derived Medicinal Products
CPMP/BWP/1737/02 EMEA Workshop on the Plasma Master File
CPMP/BWP/852/02 Final EU Recommendations for the Influenza Vaccine Composition for the season
2002/2003
CPMP/BWP/BPWG/4080/00 EMEA Workshop (13th Sept. 2000) on Viral Safety of Plasma-derived
Medicinal Products with particular focus on Non-enveloped Viruses (Published May 2001)
CPMP/BWP/819/01 Questions and Answers on Bovine Spongiform Encephalopathies (BSE) and
Vaccines
General reporting
Concept papers
Concept Papers
CHMP/BWP/124447/04 Concept Paper on the Development of a Guideline on Viral Safety Evaluation of
Biotechnological Products to be used in Clinical Trials (Released for consultation December 2004)
CHMP/BWP/64/04 Concept Paper on the need to Revise the Guideline on Production and Quality Control
of Monoclonal Antibodies (3AB4A, Revision December 1994) (Released for consultation November 2004)
CPMP/BWP/6622/02 Concept Paper on the Development of a CPMP Note for Guidance on the on
requirements for the evaluation of new adjuvants in vaccines
CPMP/BWP/1711/00 Concept Paper on the Development of a CPMP Points to Consider on the Use of
Transgenic Plants in the Manufacture of biological Medicinal Products for Human Use
CPMP/BWP/4310/00 Concept Paper on the Development of a CPMP Points to Consider on Stability and
Traceability Requirements for Vaccine Intermediates
CPMP/BWP/3326/99 Concept Paper on the Development of a CPMP Points to Consider on Xenogeneic
Cell Therapy
CPMP/BWP/1765/99 Concept Paper on the Development of a CPMP Points to Consider on Live
Attenuated Influenza Vaccines
CPMP/BWP/1764/99 Concept Paper on the Development of a CPMP Points to Consider on Cell-Derived
Influenza Vaccines
CPMP/BWP/1113/978 Concept Paper on the development of a CPMP Guideline on Comparability of
Biotechnology-derived Products
Point to consider
Points to Consider
CPMP/BWP/2289/01 Points to Consider on the Development of Live Attenuated Influenza Vaccines ( CPMP
Adopted, February 2003)
CPMP/BWP/41450/98 Points to Consider on the Manufacture and Quality Control of Human Somatic Cell
Therapy Medicinal Products (Adopted, May 2001)
CPMP/BWP/2517/00 Points to Consider on the Reduction, Elimination or Substitution of Thiomersal in
Vaccines (Adopted, April 2001)
Draft guidelines
Draft Guidelines
EMEA/CHMP/135148/04 Environmental Risk Assessments for Medicinal products containing, or
consisting of, Genetically Modified Organisms (GMOs) (Module 1.6.2) (CHMP released for consultation
January 2005)
EMEA/CPMP/5579/04 Guideline on Procedural Aspects Regarding a CHMP Scientific Opinion in the
context of cooperation with WHO for the Evaluation of Medicinal Products intended Exclusively for
Markets outside the Community (CHMP released for consultation October 2004)
EMEA/410/01 Rev.3 Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform
Encephalopathy Agents via Human and Veterinary Medicinal Products,(Released for consultation June
2004)
CPMP/BWP/764/02 Points to Consider on Quality aspects on medicinal products containing active
substances produced by stable transgene expression in Higher Plants (Released for consultation April
2002)
Approved guidelines
Adopted Guidelines
EMEABWP/125/04 Guideline on Epidemiological Data on Blood Transmissible Infections (CHMP adopted
January 2005)
CPMP/BWP/5180/03 Guideline on Assessing the risk for Virus Transmission - New Chapter 6 of the NfG
on Plasma-derived medicinal products (CHMP adopted October 2004)
EMEA/BWP/5136/03 Guideline on the Investigation of Manufacturing Processes for Plasma-Derived
Medicinal Products with Regard to VCJD risk (CHMP adopted October 2004)
CPMP/BWP/4663/03 Guideline on Requirements for Plasma Master File (PMF) Certification (CPMP
adopted February 2004) (Guidance on the so-called "2nd step", click here)
CPMP/BWP/3794/03 Guideline on the Scientific Data Requirements for Plasma Master File (PMF) (CPMP
adopted February 2004)
CPMP/4548/03 Guideline on Requirements for Vaccine Antigen Master File (VAMF) Certfiication (CPMP
adopted February 2004)
CPMP/BWP/3734/03 Guideline on the Scientific Data Requirements for Vaccine Antigen Master File
(VAMF) (CPMP adopted December 2003)
CPMP/3097/02 Guideline on Comparability of Medicinal Products containing Biotechnology-derived
Proteins as Drug Substance Non Clinical and Clinical IssuesCPMP adopted December 2003
CPMP/BWP/3207/00 Rev.1Guideline on Comparability of Medicinal Products containing
Biotechnology-derived Proteins as Active Substance -Quality Issues (CPMPadopted December 2003)
CPMP/BWP/2758/02 Guideline on Pharmaceutical Aspects of the Product Information for Human
Vaccines (Adopted by CPMP December 2003)
EMEA/410/01 Rev. 2 Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform
Encephalopathy Agents via Human and Veterinary Medicinal Products
CPMP/BWP/3068/03 Guidance on the Description of Composition of Pegylated (Conjugated) Proteins in
the SPC (Adopted by CPMP July 2003)
CPMP/BWP1793/02 Note for Guidance on the Use of Bovine Serum in the manufacture of Human
Biological Medicinal Products (Adopted by CPMP July 2003)
CPMP/BWP/3354/99 Note for Guidance on the Production and Quality Control of Animal Immunoglobins
and Immunosera for Human Use
CPMP/BWP/2490/00 Note for Guidance on Cell Culture Inactivated Influenza Vaccines (Adopted by
CPMP January 2002) - Annex to Note for Guidance on Harmonisation of requirements for Influenza
Vaccines CPMP/BWP/214/96
See also EMEA/CPMP/BWP/498/01 - Explanatory Note for Medicinal products for Human use on the
Scope of the Guideline.
CPMP/BWP/3088/99 Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer
Medicinal Products (Adopted April 2001)
CPMP/BWP/269/95 Rev.3 Note for guidance on Plasma -Derived Medicinal Products (CPMP adopted
Jan. 2001).
CPMP/BWP/328/99 Development Pharmaceutics for Biotechnological and Biological Products - Annex to
Note for Guidance on Development Pharmaceutics (CPMP/QWP/155/96)
CPMP/BWP/477/97 Note for guidance on Pharmaceutical and Biological Aspects of Combined Vaccines,
(CPMP adopted Jul. 98).
CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines
(CPMP adopted March 97)
CPMP/BWP/243/96 Note for Guidance on Allergen Products (CPMP adopted March.96)
CPMP/BWP/268/95 Note for Guidance on Virus Validation Studies:The Design, Contribution and
Interpretation of Studies validating the Inactivation and Removal of Viruses (CPMP adopted Feb.96)