GMP News - Regulatory Affairs

The US FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy (REMS) plans and to making sure they do not impede generic drug development.

The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.

There is currently a growing interest in the development of therapies derived from cannabis and its components.The FDA recently announced to form an internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD.

On 13 March, the Euroepan Medicines Agency (EMA) published a the draft ICH Guideline M10 on bioanalytical method validation for public comments.

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.

Will EU-based pharmaceutical companies still be able to use a manufacturing site for which the GMP Certificate has been issued by a UK authority? The answer is yes - but with restrictions.