GMP News - Regulatory Affairs

The EMA recently published a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population.

The EMA announced on July 14, 2017, that it has revised three post-authorization activity guidance documents, including type II variations, post-authorization safety studies and changes related to quality aspects. Read more EMA´s updated post-authorizaiton guidelines.

Generics: The US Food and Drug Administration (FDA) recently published a new Guidance regarding Prior Approval Supplements (PAS). Read more about FDA´s Guidance for Industry "ANDA Submissions - Prior Approval Supplements Under GDUFA".

The US Food and Drug Administration (FDA) finalized its revised regulations governing drug establishment registration and drug listing. Read more about the requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a biologics license application, and animal drugs.

Recently in a notice, Health Canada has given its opinion about the implementation of the ICH Q3D guideline. Read more about which information on elemental impurities in applications for new marketing authorisations of medicinal products and OTC products, or in variation applications the Canadian Agency requires.

On May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review. Read more on how agency staff in the Office of Pharmaceutical Quality (OPQ) should apply the recommendations in the ICH Q8, Q9 and Q 10 guidelines to CMC reviews.

The Europeam Medicines Agency (EMA) has published a "Reflection paper on collecting and reporting information on off-label use in pharmacovigilance“ for comment (deadline July 29, 2016). Read more about EMA's reflection paper on Off-Label-Use.