The former Annex 2 Manufacture of biological medicinal products for human use has been split into the following Annexes:
Annex 2A summarizes the requirements for the manufacture of ATMPs and harmonizes them in a "reasonable" manner with the guidelines for ATMPs published by the European Commission. The EC had included the GMP requirements for ATMPs as a stand-alone Part IV in the EU GMP Guidance in 2017. However, this step was not followed at the PIC/S. They were already critical regarding the document during the phase of consultation. In a letter to the EC, the concerns were summarized. According to the assessment of the PIC/S, the EC guideline would lower the GMP requirements for ATMPs and thus stand in contrast to the intended harmonization.
In Annex 2B, there were only minor changes compared to the EU GMP Guideline. Harmonization with Annex 2 of the EU GMP Guideline on the manufacture of biological active substances and medicinal products for human use was pursued further.
The "PIC/S Sub-Committee on Harmonization of GM(D)P" conducted the revision. Paul Gustafson, who works for the Regulatory Operations and Enforcement Branch of Health Canada, took the lead. The revision was based on the work of the PIC/S Working Group on Annex 2.
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