GMP News - Regulatory Affairs

Herbal medicinal products can be registered via the well established use approach within the EU. But what is needed for the simplified registration and how to demonstrate well established use?

The latest version of the "REPORT ON THE RISK OF POTENTIAL PRESENCE OF NITROSAMINE IMPURITIES" has been available on the APIC website since April 2021. The questionnaire is to be seen as a summary report and can be used to document the results of the risk assessments with regard to contamination by nitrosamines in APIs.

The FDA still warns companies for illegal selling Over-the-Counter CBD Products for pain relief including products listing CBD as an inactive ingredient.

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.

In a final assessment report, the CHMP has published recommendations for marketing authorisation holders of medicinal products containing sartan. Read more here about the requirements for limit values of nitrosamine impurities and for risk assessments, as well as the deadlines to be met.

The MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders.