GMP News - Herbal Medicinal Products (incl. Cannabis)

New USP Proposal for CBD Monograph

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.

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German Federal Council approves Cannabis Law

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?

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Revised GACP Guideline

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.

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How does GMP apply for Herbal Medicinal Products?

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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New Ph. Eur. Cannabis Reagents

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.

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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.

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EDQM pre-publishes Ph. Eur. Cannabis Flower Monograph

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.

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USP HMC publishes revised Cannabis Draft Monograph

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.

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