GMP News - Herbal Medicinal Products (incl. Cannabis)

10.08.22

New Edition of the Technical Guide for the Elaboration of Ph. Eur. Monographs

The European Pharmacopoeia Commission published the 8th edition of the Technical Guide for the Elaboration of Monographs. The guide helps when drafting monographs and transferring analytical methods into a compendial procedure. The previous version of the guide dated back to 2015.

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27.07.22

Extended Input Deadline for USP´s new Chapter on Quality Considerations for Cannabis

Following the previously announced elaboration of a new USP chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research the input deadline has been extended.

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27.07.22

Swissmedic´s New Website for Herbal Medicinal Products

The Swissmedic website for authorization of herbal medicinal products (HMPs) has been completely revised and updated. It provides information on simplified authorization procedures for HMPs, e.g. for "HMPs with known active substance".

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20.07.22

FDA Warning Letters for CBD Products used in Farm Animals

The FDA posted several Warning Letters to companies illegally selling cannabidiol products intended for use in food-producing animals due to safety concerns. The agency is taking these steps to protect animals and the safety of the food supply chain.

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13.07.22

What is an FDA-Approved Product?

The FDA posted an article on the ways the FDA is regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food, and cosmetics. How can you know for sure that a product is FDA-approved?

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13.07.22

GMP vs GACP: BfArM Makes some Clarifications

The German BfArM now clarified for medical Cannabis Manufacturers: A valid GMP certificate must be included with the drying step.

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29.06.22

BfArM Adjusts Specification for Medical Cannabis

Growers and importers of cannabis flowers have reported to the German BfArM that the specification requirements of the DAB monograph Cannabis Flower cannot be met, especially for low cannabinoid contents. The BfArM has now worked out a compromise for cannabis used for magistral preparations.

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22.06.22

CBD Novel Food Assessment Interrupted Due to Data Gaps

The EFSA can currently not establish the safety of cannabidiol (CBD) as a novel food due to lack of data and uncertainties about potential hazards related to CBD.

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15.06.22

Ph. Eur. Draft Monograph for CBD

Following the USP Draft Monograph for Cannabidiol (CBD) published earlier this year a draft Ph. Eur. Monograph for CBD has now been published in Pharmeuropa 34.3. The comment deadline is 30 September 2022.

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01.06.22

Microbiological Quality of Herbal Substances

The USP Botanical Dietary Supplements and Herbal Medicines Expert Committee is working on a new USP General Chapter <1114> Ensuring Microbiological Quality of Articles of Botanical Origin.

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01.06.22

USP Announces Chapter Elaboration on Quality Considerations for Cannabis

The USP Expert Committee on Botanical Dietary Supplements and Herbal Medicines announced the elaboration of a new general chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research. The input deadline for comments is 30 June 2022.

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25.05.22

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.

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18.05.22

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.

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11.05.22

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.

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04.05.22

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?

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