GMP News Drug Safety/Pharmacovigilance

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?

A global healthcare company is voluntarily recalling 1,468 product samples from the U.S. market because they were stored at temperatures below storage requirements. The products affected are used to lower blood glucose levels in people with diabetes. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

What is an eCRF? The MHRA GCP Inspectorate recently informed about the requirements for eCRFs (electronic case report forms). In addition they listed several findings from current GCP inspections.

According to recent decisions of two Administrative Courts in Germany, Berlin and Hamburg, food supplements containing cannabidiol may not be marketed without further action.

The Swiss Narcotics Act is to be amended. Among other things, the amendment provides that cannabis-based treatments can be prescribed directly by doctors without having to obtain an exceptional authorization from the Swiss Federal Office of Public Health. In addition, cultivation and export are to be permitted.

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.