EMA - Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

4th August 2021

Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders - now available.

From the EMA - "A reflection paper may be developed to communicate the current status of discussions or to invite comment on a selected area of medicinal product development or a specific topic. It can provide a framework for discussion or clarification particularly in areas where scientific knowledge is fast evolving or experience is limited. A reflection paper does not provide scientific, technical or regulatory guidance, but may contribute to future development of such guidelines, or related document."

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