NEW | EMA update on Q&As for biological medicinal products

October 3, 2023

EMA has issued an update on the Questions and Answers for biological human medicinal products, providing agreed positions by the Biologics Working Party on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures of biological human medicinal products.

The topics covered include, among others:

  • 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)


You can have a look at the complete document here: Q&As for biological medicinal products EMA

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