Real-World Data Requirements for Herbal Medicinal Products
A scientific article in the style of a white paper has been published in the journal Planta Medica. The paper on requirements for the description of herbal preparations included in real-world data (RWD) publications concludes that a precise description of herbal drugs, herbal drug preparations and HMPs is essential for the use of RWD for regulatory decisions.
Pharmeuropa Text for Comment: HPTLC for Herbal Products
Pharmeuropa has announced the availability of a new text for comment - 2.8.25. High-performance thin-layer chromatography of herbal products. The deadline for public comments is 31 December 2024.
The USP published the new General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests. The chapter is intended as an informational chapter and will become official on 1 December 2024.
The list of available reference standards is regularly revised and published on the EDQM website. The list comprises more than 3,000 substances, including chemical reference substances, herbal reference standards and biological reference preparations as well as reference spectra for carrying out tests and trials according to Ph. Eur. methods.
A revised USP HMC Cannabis monograph has been posted in April 2024. In particular, the proposed specifications for the labeled amount of tetrahydrocannabinol (THC) and cannabidiol (CBD), as well as other cannabinoids were changed.
FDA issues Warning Letters for Selling Products containing Delta-8 THC
The FDA and the Federal Trade Commission (FTC) issued Warning Letters to five companies for illegally selling copycat food products containing delta-8 tetrahydrocannabinol (delta-8 THC) and introducing them into the marketplace.
The previously published proposal for the USP Cannabidiol monograph has now been canceled and is being replaced with a new proposal. The proposed monograph aims to provide specifications for highly purified CBD from Cannabis sativa.
The German federal states have cleared the way for the legalization of cannabis. The law came into force as planned on 1 April. What will change for medical Cannabis?
Following the concept paper for updating the GACP guideline, the revised Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin has now been published. The document is open for comments until 15 July 2024.
The EMA published revised Questions & Answers on the EU framework for (traditional) herbal medicinal products, including those from a “non-European” tradition. Amongst others two new interesting questions with corresponding answers regarding GACP and GMP have been introduced.
Is it Acceptable to Mix Extract-Batches in order to Improve Batch-to-Batch Consistency?
A revision of the "Questions & answers on quality of herbal medicinal products/traditional herbal medicinal products" document was published on the website of the European Medicines Agency (EMA) on 1 February 2024.
New Ph. Eur. Chapter Comparability of Alternative Analytical Procedures
Following the draft chapter published in 2022, the new Ph. Eur. general chapter Comparability of alternative analytical procedures (5.27) has now been published in Supplement 11.5.
Now Available: Reference Standards for the new Ph. Eur. Cannabis/CBD Monographs
The new Ph. Eur. Cannabis Flower and CBD Monographs require the use of specific reference standards/substances. These reference standards/substances are now available.
FDA Publication on Elemental Impurities in Cannabis following Vaporization
Following the previously issued article on microbial contamination, authors from the FDA recently published an article on elemental impurities in cannabis following vaporization. The results indicate that a transfer of heavy metals from cannabis material to cannabis vapor may not occur during the vaporization process under the applied study conditions.
