Important Change for Entries in EudraGMDP Database
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).
The "Access Consortium", a consortium of the regulatory authorities from Australia (TGA), Canada (HBFB), Switzerland (Swissmedic), Singapore (HSA) and now also the United Kingdom (MHRA), published a three-year plan regarding planned common approaches and goals.
FDA´s Q&As on Generic Drug Development during the COVID-19 Pandemic
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.
Clinical Trial Information System - EMA publishes Sponsor Handbook
The go-live date for the CTIS is 31 January 2022. The System will then become the single entry point for clinical trial application submission, authorization and supervision in the EU. In order to help sponsors prepare for using the CTIS, the EMA has now published a handbook.
CDER published Q&A Catalogue for Generic Drug Authorisations
In September 2021, the CDER (Center for Drug Evaluation and Research) of the U.S. FDA published a so-called "Draft Guidance for Industry" for generic medicinal product authorisations in the form of a question and answer catalogue.
Updated Version of the Q&As regarding the Clinical Trials Regulation
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.
EDQM updates Guidance for Electronic Submission of CEP Applications
In July 2021, the EDQM (European Directorate for the Quality of Medicines & HealthCare) renewed the document "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" and published it on the related website on 01 September 2021.
New FDA Draft Guidance for Industry on Bioequivalence Studies
The FDA has published a draft guidance for industry entitled “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.”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).
Consultation on Amendments on Pharmacovigilance Activities
A targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities has been published on the EC website. The Regulation outlines the practical details on the performance of pharmacovigilance activities to be respected by MAHs, national competent authorities and the EMA.
Signal Management: EMA and EC agree to further extend the Pilot
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.
ICH publishes Guideline Q13 on Continuous Production
End of July 2022, the ICH (International Council for Harmonisation) published the draft guideline on continuous manufacturing, which had been awaited for two years. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues.