GMP News - Regulatory Affairs

The U.S. FDA has concluded that a new regulatory pathway for CBD is needed that balances the desire for access to CBD products with the regulatory oversight needed to manage risks.

The updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. The update includes a new Q&A regarding information about vaccine reporting.

The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products including a separate guide that contains a REMS Document Template.

The USP chapter "<1467> RESIDUAL SOLVENTS-VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES" refers to the information provided in chapter <467 RESIDUAL SOLVENTS> and has thus now also been updated. The new draft has already been published on the website of the Pharmacopeial Forum of the USP and can be commented on until 31 March 2023.

The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was jointly prepared by the EMA and the CMDh, has been updated and the latest version published on the EMA website.

The "IRIS guide to registration and RPIs" was updated again between the end of November and mid-December 2022. The "IRIS guide for applicants" has also been revised and is now valid as version 2.13. The latest versions of both documents are available on the EMA website.

In December 2022, the "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures were again revised and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at the different stages of the centralised marketing authorisation application process.