IPEC e-newsletter - Excipients Insight December 2017 - 18-12-17

 

Inside this issue

     

EC adopts GMP guidelines for advanced therapy medicinal products

The European Commission has adopted new guidelines, which it says were developed after extensive consultation with stakeholders and competent national authorities, to adapt the GMP requirements to the specific characteristics of advanced therapy medicinal products (ATMPs) such as cell and gene therapies.

They address novel scenarios such as “decentralised manufacturing, automated production, and reconstitution of ATMPs and take a risk-based approach, allowing manufacturers some flexibility in their processes and control systems, depending on the level of risk,” according to the Commission.

A question and answer document has also been published in association with the new guidance.

 

 

 

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