Swissmedic´s New Website for Herbal Medicinal Products
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 latest Updates of the EMA's Question and Answer Document on Nitrosamine Contamination
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.
FDA Warning Letter: Benzene Contamination in Hand Sanitizer
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 an article on the ways the FDA is regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food, and cosmetics. How can you know for sure that a product is FDA-approved?
Growers and importers of cannabis flowers have reported to the German BfArM that the specification requirements of the DAB monograph Cannabis Flower cannot be met, especially for low cannabinoid contents. The BfArM has now worked out a compromise for cannabis used for magistral preparations.
EMA: Another Update of the Q&As on Parallel Distribution
Already in April 2022, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website - as already reported recently. Now, the Q&As have been updated again and supplemented.
Following the USP Draft Monograph for Cannabidiol (CBD) published earlier this year a draft Ph. Eur. Monograph for CBD has now been published in Pharmeuropa 34.3. The comment deadline is 30 September 2022.
Validation of Mixing Uniformity also required for Active Ingredients
The issue of mixing uniformity has been a validation-required topic in the field of solids for years. This is even explicitly required in the US regulations (21 CFR 211.110). In a recent Warning Letter, requirements for the mixing uniformity of an active ingredient were also addressed. What did the FDA criticise?
EMA Publishes Final Guidelines on Quality and Specifications for HMPs
The EMA published the final guidelines (Revision 3) on quality and specifications for herbal medicinal products (HMPs). Amongst others, a written GACP confirmation for the herbal substance should be provided.