GMP News - Pharmaceutical Development / Clinical Trials / GCP

Documentation is an important element in the world of GMP. This applies to protocols as well as recording documents. For the field of development, the FDA is now offering a pilot program for a new function called "Snapshot" for their clinical and development guidelines. What's behind it?

The FDA published a new guidance on the readability of container labels and carton labeling design. What is the recommended font size?

Since May 2022, the new version of the "IRIS guide for applicants" is available on the EMA website. Besides formal adaptations, version 2.10 contains additions in chapter 7 and updates in chapters 2 and 6.

In order to support sponsors, clinical investigators and applicants in planning and conducting complex clinical trials (CCTs), a new Q&A document covering this topic has now been published on the European Commission (EC) website. What is a complex clinical trial?

The European Commission published an updated version of the Questions & Answers document relating to the EU Clinical Trials Regulation. What are the GMP consequences of switching the regulatory framework applicable to a clinical trial?

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.