GMP News - Quality Assurance

EMA has published a new version of the "3-year work plan for the Inspectors Working Group" for the period January 2024 to December 2026. It also includes some updated timeframes for the revision of GMP requirements.

At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.

In March 2024, the document "Unique identification of manufacturing sites linked to CEP applications, using SPOR OMS and GPS coordinates" was updated and revised and published in revision 4 on the EDQM website in April.

As previously reported, China has revised its counter-espionage law. The issue is currently attracting increasing international attention and has now also been taken up by the Financial Times. Several rejections of inspections and one arrest have already been reported.

Following the concept paper for updating the GACP guideline, the revised Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin has now been published. The document is open for comments until 15 July 2024.

The German federal states have cleared the way for the legalization of cannabis. The law came into force as planned on 1 April. What will change for medical Cannabis?

Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations?