Are you aware of recent changes from EMA pertaining to manufacturers of chemically synthesized drugs and biological products? On 9-July-2020, the EMA published a June 25th report from the Committee for Human Medicinal Products (CHMP) entitled “Assessment Report, Nitrosamine Impurities in Human Medicinal Products.” Then on 6-August-2020, the EMA posted an update to their nitrosamine web page, along with Questions and Answers for Marketing Authorization holders/applicants on the CHMP Opinion for Marketing Authorization Holders.
Important updates include:
- In addition to drugs and APIs that are chemically synthesized, biological products are now included among the medicinal products which require a review of the manufacturing processes and raw material controls.
- The risk evaluation for chemically synthesized medicines is due March 31, 2021, and for biological medicines is due July 1, 2021. This represents a delay in the due date for chemically synthesized APIs and drugs, and is the first deadline for biological products.
- Publications include links to relevant templates that EMA expects MAHs to use in communication with the health authorities. For drugs that are still in the development stage, EMA clearly states that this information should be included in the Marketing Authorization Application. If it is not included, the information will be requested during the review process.
For assistance with interpreting these requirements and implementing pragmatic solutions, contact Validant, your full-service global Regulatory, Compliance & Quality consultancy. A partner for strategic consulting, execution services and on-going support.
This article was written and shared with the consent of the author, Barbara Unger, Principal Consultant at Validant.
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