GMP News - Herbal Medicinal Products (incl. Cannabis)

02.12.20

Will CBD be Controlled as a Narcotic?

Will Cannabidiol be controlled as a narcotic in the future? This question is currently intensively discussed. The European Court of Justice recently released their opinion.

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11.11.20

French Cannabis Specifications and Quality Requirements

The French Ministry of Health has published the specifications and quality requirements for medical cannabis in the pilot phase. The document covers flowers, extracts and finished products for oral, sublingual and inhalation use (including devices).

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04.11.20

Can Cannabis be Imported into the EU without GMP Certification?

The answer to this question is: It depends. Recently, medical cannabis grown in a non-EU-GMP-certified facility in Uruguay became available on the German market.

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28.10.20

How to Demonstrate GACP-Compliance?

The requirement for a "written GACP declaration" is contained in the current draft of the EMA HMPC Guidance Document "Quality of Herbal Medicinal Products". However, some questions remain: Who creates the declaration and what does it look like?

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21.10.20

Pyrrolizidine Alkaloids: USP Proposal for Contaminant Analysis

In addition to the new USP Chapter <1567> Pyrrolizidine Alkaloids announced recently, the USP is proposing a new chapter entitled <567> Analysis of Contaminant Pyrrolizidine Alkaloids (PAs).

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23.09.20

Herbal Medicinal Products: HMPC's Statement on Pyrrolizidine Alkaloids

The Herbal Medicinal Products Committee (HMPC) of the EMA has published the draft of the updated public statement of the HMPC on pyrrolizidine alkaloids (PAs). The document contains, among other things, the limits for the maximum daily intake of PAs.

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12.08.20

Herbal Drugs: USP Proposes New General Chapter on PAs

USP´s Expert Committee for Botanical Dietary Supplements and Herbal Medicines proposes a new general chapter on Pyrrolizidine Alkaloids (PAs).

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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FDA Issues Draft Guidance for Cannabis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 The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.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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