GMP News - Pharmaceutical Development / Clinical Trials / GCP

The ICH has published a draft version of the updated principles that are currently under development by the ICH E6(R3) EWG. Amongst others, the updated version includes revised and expanded principles regarding GMP for IMPs. 

The WHO has recently published a new version of its guidelines on the transfer of technology as a draft. Many new chapters have been added to the previous document.

In order to take account of the rapid development in the field of biological medicinal products and ATMPs, the PIC/S has revised Annex 2 of its GMP Guideline and made it available for comment.

The MHRA recently published inspection findings in the conduct of post-authorization safety studies (PASS). In particular, the agency observed significant breaches of the study protocol for the MAHs non-interventional PASS during inspection at a study site.

The MHRA GCP inspectorate has continued to see non-compliance in reference safety information in clinical trials. In particular, the agency is still seeing unreported SUSARs and absence of adequate risk mitigation measures due to incorrect use of the RSI.

COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. Therefore, the FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of postapproval change submissions.

Authorisation requirements for adjusted COVID-19 vaccines: the EMA publishes recommendations for vaccine developers and manufacturers.