Following the previously announced elaboration of a new USP chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research the input deadline has been extended.
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.
In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.
In the US, there is currently a lot going on in the area of GDP. In recent weeks and months, the FDA has published several new documents related to the Drug Supply Chain Security Act (DSCSA).
In the Pharmacopeial Forum, PF 48(4), a proposal for a new USP chapter <1079.3> Monitoring DevicesTime, Temperature, and Humidity, providing background information about the science and technology of temperature and humidity monitoring over time, has been published for comments.
In June 2022, two new GPD Non-Compliance Reports were entered into the EudraGMPD Database.
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.
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.