The European Drug Shortages Formulary (EDSForm) project aims to tackle drug shortages across Europe.
The European Medicines Agency (EMA) has published two new Q&As on its website related to good manufacturing practice and good distribution practice. These are aimed specifically at wholesalers and brokers and provide information on how to recognise suspicious offers and take appropriate action.
As part of an internationally coordinated operation, Swissmedic, the Federal Office for Customs and Border Security (FOCBS) and Swiss Sport Integrity (SSI) inspected over 1,000 suspicious postal shipments. Numerous counterfeit or non-authorised medicinal products were seized during the operation.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two documents for inspectors related to remote assessments. Although the documents are primarily intended for GMP inspectors, they can also be useful for the GDP area (with appropriate modifications).
On 16 December 2024, the European Commission, the HMA and the EMA, published an updated version of the Union list of critical medicines and the updated version of the corresponding Q&A document.
If the outcome of an inspection is that a wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into the EudraGMDP database. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports issued in 2024, including the corresponding reasons for their issuance.
The official English translation of Supplement II to the Japanese Pharmacopoeia (JP) Eighteenth Edition is now available as a free download.
Financial and organizational advantages speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 24: If the pharmaceutical user has data in the cloud, what type of system is it? Is this an open or closed system according to 21 CFR Part 11?
The U.S. FDA is proposing to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. When finalized, the rule would require manufacturers of talc-containing cosmetic products (TCCPs) to test their products for asbestos using specific testing methods.
A new regulation bans the use of BPA (Bisphenol A) in the EU. In particular, the use of BPA and its salts in the manufacture of food contact materials (FCMs) and the placing on the Union market of FCMs manufactured using BPA, is prohibited.