GMP News - Regulatory Affairs

The new regulatory framework for veterinary medicinal products requires several changes to the EudraGMDP database. One important change is the integration of EudraGMDP into the EMA's Organization Management Service (OMS).

What can be done when a test or reference product batch used in the conduct of a bioequivalence study expires while the study is interrupted due to the COVID-19 pandemic? Find out in FDA´s updated Q&As on Generic Drug Development.

In September 2021, the CDER (Center for Drug Evaluation and Research) of the U.S. FDA published a so-called "Draft Guidance for Industry" for generic medicinal product authorisations in the form of a question and answer catalogue.

The European Commission published a revised Version 4 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, updates to Q&As in Chapter 11 "Arrangements for the transitional period" have been made.

The FDA has published a draft guidance for industry entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.” The document provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The FDA recommends that in vivo BE studies are accompanied by in vitro dissolution profiles. Under certain circumstances, BE can be evaluated alone by using in vitro approaches (e.g., dissolution testing).

The EMA and the European Commission have agreed to further extend the pilot on signal detection in EudraVigilance by marketing authorization holders until the end of 2022. MAHs with APIs included in the EMA list of active substances and combinations involved in the pilot should continue to monitor them in EudraVigilance.