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.
Medical Cannabis in Germany: From the BtMG to the Cannabis Act?
According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG). What changes may result?
Draft of USP Chapter <711> Dissolution (PDG harmonized document) Published for Comments
In the Pharmacopeial Forum, PF 49(3), a proposal of a revised USP General Chapter <711> Dissolution has been published for comments. The background to the publication is the efforts of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The new draft represents the Pharmacopeial Discussion Group (PDG) harmonized document.
USP Publishes Draft on Quality Requirements for Cannabis
The USP previously announced to elaborate a chapter on quality considerations for Cannabis. Now the draft chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research has been published in PF 49.3. Comments can be sent to the USP until end of July.
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.
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.
FDA Warning Letter: Root Cause of Benzene Contamination not unterstood
The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. An OTC manufacturer received information indicating that the finished drug products produced with isobutane propellants were contaminated with benzene. The company's own analyses as well as results of the FDA laboratory testing confirmed the presence of this impurity. The company failed to perform adequate investigations and so far, the root cause of the benzene contamination is not understood.
In March 2023, the EDQM once more prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" and has now published it in the newsroom of the EDQM website.
WHO: Excipients GMP Guideline published for Comments
In March 2023, the WHO published the first draft of the guideline "WHO good manufacturing practices for excipients used in pharmaceutical products" on its website for comments. The public comment period ends on 26 May 2023.
In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document providees numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.
In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.
FDA Warning Letter to Indian Manufacturer: Glycerine used in Manufacturing not Tested according to USP
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an Indian company, registered as a manufacturer of OTC and homeopathic drug products. Some of the formulations contain high percentages of glycerin, but this high-risk component was not adequately tested according to the USP requirements. Thus, it was not ensured that the relevant safety limits for the levels of diethylene glycol or ethylene glycol were met.