EMA's Questions and Answers on the Biological Medicines Marketing Authorisation Dossier Published
Recommendation
10-12 December 2024
Mastering the challenges of classic and modern microbiological methods
Questions and answers related to biologic medicines have been updated on the European Medicines Agency (EMA) website. About the background: The content described in this article is regularly developed and maintained by the Biologics Working Party (BWP) from the Committee for Medicinal Products for Human Use (CHMP). The questions have generally arisen from discussions or correspondence during the evaluation procedures for biologic medicinal products for human use. This additional information is provided as an explanation and should always be considered in the context of the European Pharmacopoeia, CHMP guidelines and other regulations.
Content of the Q&As
EMA has answered questions on the following sections in the marketing authorisation dossier:- Reprocessing (3.2.S.2.2, 3.2.P.3.3)
- Raw materials and media components (3.2.S.2.3)
- Method identification numbers (3.2.S.4.1, 3.2.P.5.1)
- Process validation, removal of process related impurities, process related impurities testing (3.2.S.2.5, 3.2.P.3.5)
- Host cell proteins testing, drug substance specification (3.2.S.3.2, 3.2.S.4.1, 3.2.S.4.5)
- Biosimilar medicinal products: characterization, side-by-side comparison, specification, biosimilarity, analytical comparability (3.2.S, 3.2.S.3.1, 3.2.S.4.1, 3.2.P.5.1, 3.2.R)
- Monoclonal antibodies specification, ADCC activity (3.2.S.4.1, 3.2.P.5.1)
- Polysorbate testing in finished product specification (3.2.P.5)
- Low Endotoxin Recovery, Endotoxin masking effect (3.2.P.5.3)
- Non-novel excipients manufactured using recombinant technology (3.2.P.4, 3.2.A.3)
The questions and the respective answers to the sections of the BWP can be read in more detail on the EMA website "Questions and answers for biological medicinal products".
Related GMP News
13.11.2024Warning Letter for Manufacturer of HCT/P Products
30.10.2024Warning Letter for an American Manufacturer of Blood Products
24.10.2024Supporting biopharmaceutical Research and Development for Europe
24.10.2024Revision of USP Chapter <1047> on Gene Therapy Medicinal Products
05.09.2024Revision of USP Chapter <1033> on Validation of Biological Assays published
05.09.2024Next Generation of Genome Editing?