Safety Reporting - Responsibilities for Investigational Drugs and Devices
The FDA published a new draft guidance on the responsibilities regarding safety reporting for investigational drugs and devices. What is required for investigational device exemption studies?
The FDA has published guidance to clarify how considerations about benefit-risk assessment are integrated into the agency´s pre- and postmarket decisions for marketing applications. Read more about FDA´s draft guidance on Benefit-Risk Assessment for New Drug and Biological Products.
The European Commission has proposed further arrangements to respond to possible difficulties in the movement of goods between Northern Ireland and Great Britain
The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. The list also includes a large number of CBD preparations.
New Updates of the Templates for Reporting Nitrosamine Contamination
Marketing authorisation holders of chemically-synthesized or biologic medicinal products are required to perform confirmatory testing after identifying a potential risk of nitrosamine contamination and report the results using specified templates. One of these reporting templates has been recently revised. Read more here about the updates to be considered in the nitrosamine contamination reporting template.
Analytical Procedure Life Cycle - New USP Chapter <1220> published
More than a year after the publication of the draft of Chapter <1220> on Life Cycle Management of Analytical Procedures, the USP has announced the final version for 01 November.
The EU will extend GMP and GDP certificates until the end of 2022 due to ongoing pandemic restrictions. The relevant document has been updated for this purpose.
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.
EMA: Update of the Q&A Documents "Centralised Procedures"
In July and September 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents on centralised procedures on their website.
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.