Science and Regulatory
 Product Development
Generic Medicines
a) Bioequivalence:
 EGA Q&A on the Revised EMA Bioequivalence Guideline, the EGA Contribution to the Promotion of Harmonised EU Interpretatation of the Revised Bioequivalnce Requirements.
The revised guideline on bioequivalence entered into force on 1 August 2010 and was discussed extensively during the 3rd EGA Symposium on Bioequivalence “Training on the revised EMA Bioequivalence Guideline” (London - 1 June 2010). This EGA publication captures the various and detailed explanations given by EU pharmacokinetic assessors on the different chapters of the revised bioequivalence guideline with a view to clarify the intentions of the EMA drafting team and favour a harmonious interpretation by industry and assessors alike. We hope this document will contribute to foster a harmonious implementation of the guideline approach to bioequivalence by both industry and regulators.
Contact information J. Maréchal-Jamil jmarechal@egagenerics.com
• Click here for the EMA Guideline on Bioequivalence (Jan 2010)
Requirements for Clinical Documentation for Orally Inhaled Products (OIP)
...including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of Asthma and Chronic Obstructive Pulmonary Disease
EMEA, (COPD) CPMP/EWP/4151/00 Rev. 1
• Released for consultation Oct 2007
• Deadline for comments 30 Apr
2008
Questions & Answers on the Bioavailability and Bioequivalence Guideline
EMEA, Ref: EMEA/CHMP/EWP/40326/2006
• Adopted 27 July 2006
Note For Guidance on the Investigation of Bioavailability and Bioequivalence
EMEA, Ref: CPMP/EWP/QWP/1401/98
• Adopted July 2001
Clinical Requirements for Locally Applied, Locally Acting Products containing Known Constituents
EMEA, Ref: EMEA/CHMP/EWP/239/95 final
• Approved November 1995
Bioequivalence and Generic Medicines
Dr. Pieter Zanen, Dept. Pulmonary Diseases, Univ. of Utrecht
A technical review of the scientific approach to bioequivalence studies taken by the generics industry.
b) Selected Quality Guidelines Relevant to Generic Medicinal Products:
Annex to Pharmaceutical Development (ICH Q8)
EMEA, Ref: EMEA/CHMP/ICH/518819/2007
• Released for consultation Nov 2007
• Deadline for comments 31 May 2008
Assessment of the Quality of Medicinal Products Containing Existing/Known Active Substances
EMEA, Ref: EMEA/CHMP/CVMP/QWP/450653/2006
• Released for Consultation Jul 2007
• Deadline for comments 31 January 2008
Pharmaceutical Development (ICH Topic Q8)
EMEA, Ref: EMEA/CHMP/167068 /2004-ICH Q8
• Adopted by CHMP Nov 2005 | Entry into Operation May 2006
Summary of Requirements for Active Substances in the Quality Part of the Dossier
EMEA, Ref: CPMP/QWP/297/97 Rev.1 corr
• Adopted by CPMP and CVMP June 2004 | Entry into Operation February 2005
Note for Guidance on the European Drug Master File procedure
EMEA, Ref: QWP/QWP/227/02 (EMEA/CVMP/134/02)
• Adopted by CPMP/CVMP, January 2004/February 2004 | Entry into Operation 31 August 2004
Note for Guidance on Stability Testing of Existing Active Substances and Related Finished products
EMEA, Ref: CPMP/QWP/122/02 Rev.1
• Adopted by CPMP December 2003 | Entry into Operation March 2004
Biosimilar Medicinal Products
Please refer to the section on Biosimilar
Medicines.
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