GMP News - Herbal Medicinal Products (incl. Cannabis)

31.08.23

USP adopts new Chapter on Pyrrolizidine Alkaloids

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.

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31.08.23

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.

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31.08.23

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.

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24.08.23

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs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.

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20.07.23

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?

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20.07.23

Draft Bill on the German Cannabis Act published

The German draft bill on the controlled use of cannabis (German Cannabisgesetz - CanG) is available. Will cannabis now be removed from the German BtMG?

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20.07.23

Ph. Eur. Update on Pharmaceutical Preparations

A revised version of the Ph. Eur. general monograph Pharmaceutical Preparations has been published. In particular a reference to the general Ph. Eur. chapter Contaminant pyrrolizidine alkaloids (2.8.26) has been added.

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27.06.23

EMA Update on GACP Revision

The European Medicines Agency (EMA) has published on its website the detailed minutes of the Herbal Medicinal Products Committee (HMPC) meeting from 13-15 March 2023. In the meeting, the HMPC discussed some issues known to cause difficulties in procedures and ideally to be addressed during the current GACP revision.

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27.06.23

Updated Public Statement of the HMPC on HMPs containing Estragole

In 2005, the HMPC prepared the "Public statement on the use of herbal medicinal products containing estragole". Now, several footnotes were added in Table 1 of the document regarding the provided examples of estragole-containing plants.

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27.06.23

New Edition of the Herbal Guide

The EDQM has published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. The Guide provides general guidance on the structure of Ph. Eur. monographs of herbal drugs and herbal drug preparations and on the information to be included in them. In addition, principles for the preparation and revision of herbal monographs are explained.

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27.06.23

Cannabis Reference Standards DAB

The amended German Pharmacopoeia (Deutsches Arzneibuch, DAB) is valid from 1 August 2023. The DAB 2023 now includes several revised texts for Cannabis reagents.

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17.05.23

Medical Cannabis in Germany: From the BtMG to the Cannabis Act?

According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG). What changes may result?

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16.05.23

USP Publishes Draft on Quality Requirements for Cannabis

The USP previously announced to elaborate a chapter on quality considerations for Cannabis. Now the draft chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research has been published in PF 49.3. Comments can be sent to the USP until end of July.

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16.05.23

USP Draft for Dronabinol Capsules

The USP published the draft monograph for Dronabinol Capsules in PF 49.3. Comments can be sent to the USP until end of July.

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16.05.23

Herbal Medicines for Children

The EMA has published on its website an updated overview with recommendations for the use of herbal medicinal products (HMPs) in children.

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