GMP News - Herbal Medicinal Products (incl. Cannabis)

A new USP chapter <1567> on pyrrolizidine alkaloids (PAs) is being proposed. It discusses some analytical methods and existing challenges to measure PA contaminants in herbal medicinal products.

Canada will lead an ISO international IWG to develop three technical guidelines for Cannabis including one on Good Production Practices (GPP).

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. 

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 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.

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.

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.