GMP News - Herbal Medicinal Products (incl. Cannabis)

12.08.20

FDA Issues Draft Guidance for Cannabis

The FDA issued a new guideline entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.

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27.05.20

Is Cannabis an API, a Herbal Drug or a Herbal Medicinal Product?

The classification defines, among other points, which kind of GMP certification is needed for export / import of Cannabis Flower to the EU and Germany.

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13.05.20

USP´s Quality Considerations for Medical Cannabis

The USP Cannabis Expert Panel has published an article on the quality requirements for medical cannabis in the Journal of Natural Products. The article describes the appropriate use of USP General Chapters related to chromatographic methods and controls for contaminants.

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06.05.20

New Ph. Eur. Chapter on Essential Oils

The general Ph. Eur. monograph on Essential Oils has been published for comment in the recent issue of Pharmeuropa together with a proposed new Ph. Eur. chapter 5.30. Monographs on essential oils.

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08.04.20

German Pharmacopoeia Monograph for Cannabis Extracts

The monograph "Cannabis Extract, Standardized" (Cannabis extractum normatum) will be added to the German Pharmacopoeia (DAB 2020).

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11.03.20

UK Changes Import Restrictions for Cannabis

UK will implement faster access to medicinal cannabis as import restrictions are changed. Thus, patients will be able to get their treatment in days rather than months.

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19.02.20

CBD is controlled as a medicine in Finland

The Finnish Medicines Agency (Fimea) recently stated that Cannabidiol (CBD) is controlled as a medicine in Finland.

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17.02.20

France Takes Further Steps Regarding Medical Cannabis

The French National Agency for Medicines and Health Products Safety carries on the work on medical cannabis started in 2018 and has now published a dossier on cannabis for medical use.

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29.01.20

Medicinal Products for Human Use: EMA's Highlights 2019

The EMA has published the highlights for human medicines for 2019. These include 30 new APIs and one cannabis product.

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08.01.20

Ph. Eur. Draft Chapter for PA Contaminants in Herbal Drugs

A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of  Pharmeuropa. The scope of this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and herbal medicinal products.

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04.12.19

FDA continues to warn companies for illegally selling CBD products

The FDA recently issued 15 warning letters to companies for illegally selling products containing cannabidiol (CBD).

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27.11.19

Cannabis Monograph in the Swiss Pharmacopoeia

Supplement 11.3 of the Swiss Pharmacopoeia (Ph. Helv.) includes a new monograph on Cannabis Flowers. 

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13.11.19

FDA works on regulatory pathways for CBD products

Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients.

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09.10.19

How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links.

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26.09.19

Official Danish Cannabis-Monograph

Denmark has published its official pharmacopoeial monograph for Cannabis: Cannabisblomst (Cannabis flos).

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