EMA's Questions and Answers on the Biological Medicines Marketing Authorisation Dossier Published

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".