US FDA: Draft on Data Integrity for BE/BA Studies published
At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.
EDQM: Updated Information on the Quality Overall Summary (Module 2)
The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. The document was first published in 2015 and is intended to provide assistance for CEP applicants.
In March 2024, the document "Unique identification of manufacturing sites linked to CEP applications, using SPOR OMS and GPS coordinates" was updated and revised and published in revision 4 on the EDQM website in April.
EMA: Update of the Q&A Documents on the Topic of "Centralised Procedures"
In March 2024, the "Questions & Answers (Q&A)" documents relating to centralised procedures were again updated and published on the website of the European Medicines Agency (EMA).
Following the concept paper for updating the GACP guideline, the revised Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin has now been published. The document is open for comments until 15 July 2024.
APIC: Best Practices Guide for dealing with Suppliers
The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.
The German federal states have cleared the way for the legalization of cannabis. The law came into force as planned on 1 April. What will change for medical Cannabis?
FDA Warning Letter: Missing Ongoing Stability Studies for APIs
In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 2023. According to the Warning Letter the company missed to have an appropriate stability program for its API in place.
Ethylene and Diethylene Testing - Warning Letter and Regulatory Activities
Since 2022, the series of Warning Letters, but also the activities of the authorities on the subject of testing for ethylene and diethylene glycol, has not stopped. The FDA recently published another Warning Letter.
In March 2024, the ECHA (European Chemicals Agency) published the next steps of its working groups with regard to the restriction of "PFAS" (per- and polyfluoroalkyl substances) in Europe on its website.
FDA sends Warning Letter to Canadian OTC Manufacturer
A manufacturer of over-the-counter (OTC) drug products based in Canada received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Warning Letter to Chinese OTC Manufacturer: Violations concerning Identity Testing, Stability Program and Quality Unit
The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products. The violations were identified during the FDA's review of records submitted by the company in response to an official request.
APIC Quality Agreement Guideline: Update published
The first version of the document "Quality Agreement Guideline & Template" was published in 2009, updated in 2017 and has now been revised again. Version 3 of the guideline was published in January 2024 and is now available on the APIC website in the "Publications" tab.
Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data
A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.
FDA Warning Letter to Drug Manufacturing Facility in Thailand
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.