At the end of July 2022, the GAMP organization has published the 2nd Edition of GAMP® 5. What are the main changes and developments compared to the previous version, which has been available since 2008?
The EMA Committee on Herbal Medicinal Products (HMPC) published the minutes for the HMPC meeting held in May 2022. The Meeting Protocol contains several interesting developments regarding Cannabis. Will it be possible for regulatory submissions to use the well-established medicinal use pathway in the EU?
Ph. Eur. 11.0 has been published in July 2022. Amongst others, the 11th Edition contains the previously announced new general chapter 5.26. Implementation of Pharmacopoeial Procedures providing a 2-step approach.
The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.
In the Pharmacopeial Forum, PF 48(4), a new version of USP Chapter <1094> Capsules—Dissolution Testing And Related Quality Attributes was published. Based on comments received on the version of the chapter official as of December 1, 2020, several revisions are proposed.
The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.
Despite being forbidden as food additive titanium dioxide may still be used provisionally in medicinal products. But the EMA appeals to the pharmaceutical companies to seek intensively for alternative excipients and has published a new questions and answers document to provide assistance. Read here what marketing authorisation holders and applicants have to observe when replacing titanium dioxide or developing new formulations for medicinal products with alternative excipients.
WHO, KRINKO and RKI are concerned with the pending biocide approval and indispensability of ethanol as a component of infection prevention and healthcare. They have published a corresponding statement.
In the Pharmacopeial Forum, PF 48(4), a stimuli article entitled "Consistent Terminology for Advancement of NMR Spectroscopy" was published. According to the authors, the paper builds the foundation for a modular, coherent, and standardized terminology, a condition necessary for a healthy life cycle of research data, including their management and reuse.
The Swissmedic website for authorization of herbal medicinal products (HMPs) has been completely revised and updated. It provides information on simplified authorization procedures for HMPs, e.g. for "HMPs with known active substance".
The Drug Supply Chain Security Act (DSCSA) distribution security requirements will come into effect in November next year. To help trading partners comply with the DSCSA, the U.S. FDA recently issued revised versions of two previously published draft guidances.
Dr Afshin Hosseiny, who has been the European GDP Association's Advisory Board Chairman since its foundation, has decided to step down from this position. For this reason, Alfred Hunt joined as the Deputy Chair in 2021. After a year of the two working together, Alfred Hunt has now taken over the role as the Chairman.
In the Pharmacopeial Forum, PF 48(4), a proposal for a new USP chapter <1079.3> Monitoring Devices—Time, Temperature, and Humidity, providing background information about the science and technology of temperature and humidity monitoring over time, has been published for comments.
The electronic application forms for submission of variations (eAFs) for medicinal products for human and veterinary use were updated in June and are listed in the latest versions on EMA's eSubmission website.
The EMA and CMDh question and answer collection on nitrosamine impurities in APIs and medicinal products is a "living" document that is updated at irregular but short notice intervals. You can find out here which current requirements and changes with regard to nitrosamine impurity limits, risk assessments and reporting obligations are important for marketing authorisation holders.
Almost 1,600 interested colleagues downloaded version 1 of the ECA Expert Task Force's Contamination Control Strategy Guide from the ECA Foundation website - and numerous comments came in. This feedback has now been incorporated into a revised version of the CCS Guide.
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a South Korean manufacturer of OTC drug products. During an FDA laboratory testing of a batch of hand sanitizer, the impurity benzene at unacceptable levels was found. After a review of records and other information provided by the manufacturer, the FDA came to the conclusion that the quality assurance within the facility is not functioning in accordance with CGMP requirements.
The FDA posted several Warning Letters to companies illegally selling cannabidiol products intended for use in food-producing animals due to safety concerns. The agency is taking these steps to protect animals and the safety of the food supply chain.