GMP News Drug Safety/Pharmacovigilance

To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation, the EMA is preparing a dedicated guidance on the protection of personal data in the CTIS. The agency has published a public consultation document to allow for wider stakeholder input.

The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

The FDA has issued a questions and answers document to assist industry and State and local governments in understanding the effects of the Uniform National Policy on drug product tracing.

The EMA published the Annual report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) containing examples of findings observed during recent GCP inspections. In addition, the 3-year work plan for the GCP IWG has been released.

In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.

Following the start of the application of the EU CTR on 31 January 2022, the MHRA has launched an 8-week public consultation on proposals for legislative changes for clinical trials. Will the UK align with the EU CTR requirements, e.g. regarding labelling of IMPs?