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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NEWS | Update from FDA

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an abbreviated new drug application (ANDA), or a prior approval supplement (PAS) to an ANDA. This guidance explains how FDA incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023- 2027” (GDUFA III commitment letter). Specifically, this guidance describes instances when an early assessment or “DMF prior assessment,” could be requested by a DMF holder and the circumstances under which FDA would commence an early assessment of Type II API DMFs 6 months prior to an ANDA or PAS submission referencing the DMF. It also provides recommendations for such DMF holders when making a request. The guidance does not apply to Type II API DMFs used to support new drug applications (NDAs), submissions related to ANDAs that are not described above, or any other types of DMFs.

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