Since May 2022, the new version of the "IRIS guide for applicants" is available on the EMA website. Besides formal adaptations, version 2.10 contains additions in chapter 7 and updates in chapters 2 and 6.
The EFSA can currently not establish the safety of cannabidiol (CBD) as a novel food due to lack of data and uncertainties about potential hazards related to CBD.
Already in April 2022, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website - as already reported recently. Now, the Q&As have been updated again and supplemented.
The U.S. Food and Drug Administration (FDA) published a Form 483 after an inspection at an Indian drug manufacturing side. The lack of control over compression machines settings led to not meeting the dissolution specifications. As the investigations were limited to the directly affected batch only, it is not excluded that other products may be affected by the same problem. Furthermore, the stability program was not followed to complete the testing within the predefined time frame.
In order to support sponsors, clinical investigators and applicants in planning and conducting complex clinical trials (CCTs), a new Q&A document covering this topic has now been published on the European Commission (EC) website. What is a complex clinical trial?
With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.
Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.
The European Commission published an updated version of the Questions & Answers document relating to the EU Clinical Trials Regulation. What are the GMP consequences of switching the regulatory framework applicable to a clinical trial?
Following the USP Draft Monograph for Cannabidiol (CBD) published earlier this year a draft Ph. Eur. Monograph for CBD has now been published in Pharmeuropa 34.3. The comment deadline is 30 September 2022.
The Dosage Forms Expert Committee intends to revise USP General Chapter <711> Dissolution. Based on the comments received, the previously proposed revision, published in Pharmacopeial Forum 48(2) in March 2022, has been canceled. It is expected that a new proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 48(6) in November 2022.