GMP News - Herbal Medicinal Products (incl. Cannabis)

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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24.07.19

French pilot programme for medical cannabis

The objective of the French pilot programme is to follow the recommendations of the CSST to evaluate cannabis prescribing and dispensing, and to collect safety and efficacy data. However, medical cannabis is not expected to be legalized in France prior to the end of 2021.

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17.07.19

New Zealand proposes new legislation for medical cannabis

New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.

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10.07.19

Canada´s New Regulatory Approach for Cannabis Products

Health Canada proposes a regulatory pathway for a new class of cannabis products referred to as Cannabis Health Products that would not require practitioner oversight.

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12.06.19

German Pharmacopoeia Draft Monograph for Cannabis Extracts

A draft for a new German Pharmacopoeia monograph entitled "Cannabis Extract, Standardized (Cannabis extractum normatum)" has been published in the (German) Bundesanzeiger.

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05.06.19

Cannabis - BfArM awards remaining contracts

The time has come for Cannabis "Made in Germany". The German Federal Institute for Drugs and Medical Devices (BfArM) has completed the award procedure for the cultivation of cannabis.

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08.05.19

BfArM awards first contracts for Cannabis

The BfArM has awarded the first contracts for the cultivation of medicinal Cannabis in Germany to two manufacturers. This means that the cultivation of pharmaceutical quality Cannabis in Germany can now commence.

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10.04.19

FDA establishes a working group on cannabis and cannabis-derived products

There is currently a growing interest in the development of therapies derived from cannabis and its components.The FDA recently announced to form an internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD.

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03.04.19

GMP for Cannabis - What is required?

More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?

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