Herbal Reference Standards - What are Active and Analytical Markers?
Active and analytical markers are used for release and stability testing of herbal substances, preparations and HMPs. The EMA provides guidance on the selection of markers in a reflection paper on markers used for quantitative and qualitative analysis.
The EMA committee adopted a concept paper for the revision of the Guideline on Good Agricultural and Collection Practice (GACP). Interested parties are invited to provide comments by 15 March 2022.
HMPC adopts revised Quality Guidelines for Herbal Medicinal Products
EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement?
Medical use of cannabis has been legalized in Panama in October 2021. The new regulatory framework allows the use and controlled access to medical cannabis for therapeutic, medical, veterinary, scientific and research purposes.
The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.
The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. The list also includes a large number of CBD preparations.
USP´s Expert Committees for Non-Botanical & Botanical Dietary Supplements and Herbal Medicines propose the elaboration of a new USP general chapter <2760> on impurities in food supplements.
MHRA Guidance for the Supply of Medical Cannabis Products
The MHRA published an updated Guidance on manufacturing, importing, distributing and supplying of cannabis-based products for medicinal use. Amongst others, the MHRA will require a valid GMP certificate for the site of manufacture.
EMA Update of the Q&As on Herbal Medicinal Products
The updated EMA document "Regulatory Q&A on herbal medicinal products" contains several revised Q&As including the Q&As regarding the requirements for the simplified registration procedure.
EMA adopts final Public Statement on Pyrrolizidine Alkaloids
The HMPC adopted the final Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs. Amongst others, it is stated that PA specifications are no longer considered necessary for essential oils.
Malta´s Medicines Authority issued a document which provides general guidance on medical cannabis production. According to the agency applications for medical cannabis production must be completed and the licence and EU-GMP certificate must be granted before production activities are carried out.
FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients
The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.
The 10th Edition of The International Pharmacopoeia is now available online. It contains recommended procedures for analysis and specifications for APIs and dosage forms.
