The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" and the associated templates were finalised in March and April 2023 and are now available on the APIC website.
FDA Paper on Artificial Intelligence in the Manufacture of Medicines
The US FDA recently published a discussion paper addressing artificial intelligence in the manufacturing of medicinal products. The FDA is considering the extent to which its risk-based regulation is applicable to AI technologies in the manufacturing of medicinal products.
In February and April 2023, the "IRIS guide to registration and RPIs" was updated again and is now valid as version 2.13. Like the "IRIS guide for applicants" and "IRIS guide to parallel distribution applicants", the latest versions of this document are available on the EMA website.
EMA updates Timelines of eAFs for Variations for Medicinal Products for Human Use
In future, submissions of variation notifications for medicinal products for human use are to be made exclusively via the electronic application forms (eAFs). The timelines for the full implementation of these systems have now been updated again and are listed on the EMA website in the PLM Portal (Product Lifecycle Management Portal).
The CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) updated the Q&A document on "Renewals" in March 2023 and published it on the HMA (Heads of Medicines Agencies) website in the CMDh - Questions & Answers section in April.
The MHRA published their GCP Inspections Metrics Report, covering the period from 1 April 2019 to 31 March 2020. Critical observations were related e.g. to data integrity, IMP management, protocol compliance, and pharmacovigilance.
New Definition of Pharmaceutical Grade Plastic Packaging Materials
The proposed USP General Chapter <1031> The Biocompatibility of Pharmaceutical Packaging Systems and their Materials of Construction has been published for comment in the current issue of Pharmacopeial Forum. It outlines a risk-based approach to biocompatibility evaluation.
GMP Update: Consequences from the New EU Commission Proposal
The EU Commission has published the proposal for the revision of the EU pharmaceutical legislation. The changes are to be regulated in a directive and a regulation. There are also GMP-relevant changes.
EMA adds Disclaimer to the Reflection Paper on the Use of IRTs
The European Medicines Agency added a disclaimer to the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates to address its applicability regarding the European Clinical Trials Regulation (CTR).
The response to the consultation on reforming the UK clinical trials regulation has been published. According to the press release, a series of new measures will be introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA).