GMP News - Herbal Medicinal Products (incl. Cannabis)


EMA Publishes Final Guidelines on Quality and Specifications for HMPs

The EMA published the final guidelines (Revision 3) on quality and specifications for herbal medicinal products (HMPs). Amongst others, a written GACP confirmation for the herbal substance should be provided.



FDA Warning Letters for Products Containing CBD and Delta-8 THC

The FDA issued several Warning Letters to companies for illegally selling CBD products and products labeled as containing delta-8 THC. Violations include the marketing of unapproved new drugs, misbranding, and adding delta-8 THC to food products.



How to Demonstrate Comparability of Analytical Procedures

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.



EMA´s Cannabis Glossary

The glossary summarizes existing scientific and legislative terminology relevant for medicinal products containing Cannabis-derived active substances. What is CBD oil and what is Cannabis oil?



Revised Technical Guide for Metals and Alloys

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.



Still Issues with CBD Products

The FDA issued again Warning Letters to several companies for selling Cannabidiol (CBD) products with misleading product claims.



France Legalizes Medical Cannabis Cultivation

France is moving forward regarding medical cannabis cultivation and production. As of March 1, it is legal to cultivate cannabis for medical purposes in France.



German Pharmacopoeia Drafts for Cannabis Reference Substances

The Expert Committee for Pharmaceutical Biology has recommended drafts for revised cannabis reagent descriptions for inclusion in the German Pharmacopoeia (DAB).



Will there be an EU Herbal Monograph for Cannabis?

EMA´s HMPC announced the start of several activities relating to regulatory requirements and standards for medical cannabis. Amongst others, the HMPC will establish some basic information regarding existing standard requirements for herbal medicinal products (HMPs).



Update on Quality Topics for Herbal Drugs

EMA´s HMPC published the HMPC Work plan for 2022. Amongst others, the HMPC plans to establish a Guidance on New Manufacturing Techniques addressing, for example, supercritical CO2-extracts.



Herbal Drugs: Concept Paper on GACP Revision Published

EMA´s HMPC published the concept paper on the revision of the guideline on good agricultural and collection practice for starting materials of herbal origin. Amongst others, the revision will address the need for clarification regarding GMP vs GACP.



CMDh: Adjustments to the Guide for Electronic Submissions (eAF)

A new version of the "Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation" was prepared in December 2021 and has now been published on the HMA (Heads of Medicines Agencies) website. This document is intended to serve as a supporting guide for the preparation of the electronic application form for the submission of medicinal products for human use and for the registration of traditional herbal medicinal products.



How to keep up to date with GMP

How can you stay up to date with the ongoing changes in the GMP world? This question is frequently addressed during ECA courses and conferences. ECA´s weekly GMP Newsletter informs you about all relevant updates in the GxP arena.



Final EMA Guidelines on Quality Requirements for IMPs

The final EMA Guidelines on the quality requirements for IMPs (pharmaceutical and biopharmaceutical drugs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. Many of the comments related to the question "What is a Non-substantial Modification?".



Herbal Drugs: Ph. Eur. Cannabis Monographs and other relevant Topics

EMA´s Herbal Medicinal Products Committee (HMPC) released the minutes for the HMPC meeting held in November 2021. Amongst others, the HMPC noted three new Ph. Eur. Cannabis Monographs for flowers and extracts in the pipeline. Other relevant topics were nitrosamines, GACP revision and elemental impurities in herbal medicinal products.


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