China Revises the Provisions for Lot Release of Biological Products

Pursuant to the new Vaccine Administration Law and the revised Drug Administration Law, the Provisions for Lot Release of Biological Products was revised by the State Administration for Market Regulation, with the aim of ensuring product quality and supply. The provisions will be implemented from March 1, 2021.

The Provisions has eight chapters and 48 articles, and the main amendments include:

  1. To clarify the division of responsibilities of lot release agencies, improving the procedures for investigating and handling major product risk
  2. To standardise lot release requirements, clarify exemptions for lot release , release tests and frequency requirements, strengthen manufacturing process deviations management
  3. To establish marketing authorisation holders’ responsibilities, strengthening product lice-cycle management requirements.

Next steps, the National Medical Products Administration (NMPA) will formulate supporting documents to ensure that the various regulations are implemented and ensure that biological products such as vaccines are safe and effective.

Refer to NMPA website for more details on 市场监管总局发布《生物制品批签发管理办法》

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