GMP News - Regulatory Affairs

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its GMP guide to reflect the EU Clinical Trials Regulation, which became applicable on 31 January 2022. In addition, a new PIC/S Annex 16 on the certification by the authorized person and batch release has been included.

In February 2022, the EMA published on its website the updated and revised versions of the "Questions & Answers (Q&A)" documents related to centralised marketing authorisation procedures.

A regulation strengthening the role of the EMA in crisis preparedness and management has been published in the Official Journal of the EU. The document also assigns several new tasks to the EMA.

The FDA announced that the agency is adjusting its planned inspection activities to the spread of the Omicron variant and has therefore temporarily postponed certain inspection activities.

Marketing authorisation holders of medicinal products that contain sartan or sartan derivatives as active ingredients are required to submit the results of the review of their products under the "Call for Review" via variation applications. Find out what requirements must be met in this regard in the CMDh's recently updated Q&A document.

The European Commission published an updated version of the Questions & Answers document relating to the Clinical Trials Regulation (EU) No 536/2014. What documentation is required in the application for the authorization of a clinical trial relating to GMP for IMPs?

To ensure effective and efficient safety assessment of clinical trials, the EU Commission published rules and procedures for the cooperation of the Member States. The new Regulation will become applicable on 31 January 2022 - together with the Clinical Trials Regulation (EU) No 536/2014.