The New Ph. Eur. Monographs Cannabis Flower and CBD are now Published
The Ph. Eur. Suppl. 11.5 is now available containing the new Ph. Eur. Cannabis Flower monograph and the new Ph. Eur. monograph Cannabidiol (CBD). The Ph. Eur. CBD monograph now clearly defines: CBD is isolated from the Cannabis sativa L. plant.
Medical Cannabis - FDA's Perspective on Research and Drug Development
In addition to the recently published FDA guideline on Quality Considerations for Clinical Research with Cannabis the FDA now published an article to assist researchers with developing cannabis-derived product (CCDP) clinical research programs.
Swissmedic Clarifies GMP Requirements for Formula Drugs
The Swissmedic recently clarified some requirements for the manufacture and marketing of formula drugs (e.g. "Formula magistralis" medicinal products) by issuing an updated version of their corresponding guidance document. The guideline is the basis for "GMP inspections for formula drugs" carried out by the cantonal inspectorates and Swissmedic.
Following the previously pre-published Ph. Eur. Cannabis Flower Monograph and the announced Ph. Eur. CBD Monograph, four new Ph. Eur. cannabis reagents are needed for quality control purposes. The description of these Cannabis reagents will be published in the European Pharmacopoeia (Ph. Eur.) Supplement 11.5.
FDA Delays Requirements for Cosmetic Facility Registration and Product Listing
The U.S. FDA issued a guidance on the delay of enforcement of the requirements for cosmetic product facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.
As previously announced the new Ph. Eur. monograph Cannabis flower was adopted and will be published in Ph. Eur. Supplement 11.5 in January 2024. Now, the Ph. Eur. decided to make the monograph immediately available on the EDQM website for information.
The USP Herbal Medicines Compendium (HMC) published a revised version of the previously proposed Cannabis Species Inflorescence monograph. In particular, the Content of Terpenes section has been removed from Specific Tests because there is insufficient information to support the use of terpenes for medical purposes.
The German Federal Cabinet has adopted the draft of an "Act on the Controlled Use of Cannabis and on the Amendment of Further Regulations" (Cannabis Law - CanG).
EMA issues Concept Paper on modern Manufacturing Techniques used for HMPs
The Committee on Herbal Medicinal Products (HMPC) adopted the Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations. The proposed reflection paper should support the industry in the development and application of modern manufacturing methods regarding herbal preparations.
Denmark clarifies Status of the Ph. Eur. Cannabis Monograph
The Danish Medicines Agency clarified that the Danish monograph for Cannabis Flower will become invalid and removed from the Executive Order on Danish Drug Standards once the Ph. Eur. Cannabis monograph becomes official.
The USP adopted the new general chapter <1567> Pyrrolizidine Alkaloids as Contaminants. Twenty-eight PAs are selected to be monitored and manufacturers of herbal medicinal products should use a risk-based approach for determining appropriate limits and testing requirements.
Proposed Product Quality Tests for Food Supplements
The USP proposed a new General Chapter <2800> Multi-Ingredient Dietary Supplement Products - Product Quality Tests in the Pharmacopeial Forum. The chapter is intended as an informational chapter, not as a requirement for compliance.
FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
The FDA issued a new guidance to provide general considerations to sponsors developing psychedelic drugs for medical use. According to the agency, there has been growing interest in the therapeutic potential of psychedelic drugs. This is the first FDA guidance that presents considerations for designing clinical trials for psychedelic drugs.
The German draft bill on the controlled use of cannabis (German Cannabisgesetz - CanG) is available. Will cannabis now be removed from the German BtMG?
Ph. Eur. Monographs for Cannabis Flower and CBD adopted
The EDQM recently announced that the final Ph. Eur. Monographs for Cannabis flower and Cannabidiol (CBD) will be published in Ph. Eur. Supplement 11.5 with an implementation date of 1 July 2024. Will it be a step forward to EU harmonization of Quality Requirements?
