GMP News - Herbal Medicinal Products (incl. Cannabis)

The FDA published the final guidance on Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.

The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.

The International Pharmacopoeia (Ph. Int.) is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation. Now, the 11th Edition of the Ph. Int. has been published.

The Danish Medicines Agency has prepared a new guidance for the pilot programme on cannabis products. Amongst others, the document contains GMP and other quality requirements for Danish-made cannabis products.

The U.S. FDA has concluded that a new regulatory pathway for CBD is needed that balances the desire for access to CBD products with the regulatory oversight needed to manage risks.

Australia´s Therapeutic Goods Administration (TGA), which regulates Medicinal Cannabis in Australia, has put out its latest Compilation regarding the production and import regulations (TGO 93). As of July 2023, all imported medicinal cannabis products released for supply in Australia will have to present evidence to be produced under GMP.

The U.S. FDA warns five companies for illegally selling food and beverage products containing cannabidiol (CBD). According to the agency, the use of CBD raises safety concerns, especially with long-term use.