GMP News - Herbal Medicinal Products (incl. Cannabis)

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.

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.

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.

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.

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.

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.

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.

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?

04.05.22

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.

13.04.22

Still Issues with CBD Products

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

30.03.22

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.

23.03.22

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).

16.03.22

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).

16.03.22

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.

09.03.22

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.

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GMP News - Herbal Medicinal Products (incl. Cannabis)

CBD Novel Food Assessment Interrupted Due to Data Gaps

Ph. Eur. Draft Monograph for CBD

Microbiological Quality of Herbal Substances

USP Announces Chapter Elaboration on Quality Considerations for Cannabis

EMA Publishes Final Guidelines on Quality and Specifications for HMPs

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

How to Demonstrate Comparability of Analytical Procedures

EMA´s Cannabis Glossary

Revised Technical Guide for Metals and Alloys

Still Issues with CBD Products

France Legalizes Medical Cannabis Cultivation

German Pharmacopoeia Drafts for Cannabis Reference Substances

Will there be an EU Herbal Monograph for Cannabis?

Update on Quality Topics for Herbal Drugs

Herbal Drugs: Concept Paper on GACP Revision Published

Recommended Event

The QP in Switzerland Role, Accountability and Liability of the Responsible Person

GMP News - Herbal Medicinal Products (incl. Cannabis)

CBD Novel Food Assessment Interrupted Due to Data Gaps

Ph. Eur. Draft Monograph for CBD

Microbiological Quality of Herbal Substances

USP Announces Chapter Elaboration on Quality Considerations for Cannabis

EMA Publishes Final Guidelines on Quality and Specifications for HMPs

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

How to Demonstrate Comparability of Analytical Procedures

EMA´s Cannabis Glossary

Revised Technical Guide for Metals and Alloys

Still Issues with CBD Products

France Legalizes Medical Cannabis Cultivation

German Pharmacopoeia Drafts for Cannabis Reference Substances

Will there be an EU Herbal Monograph for Cannabis?

Update on Quality Topics for Herbal Drugs

Herbal Drugs: Concept Paper on GACP Revision Published

Recommended Event

The QP in Switzerland Role, Accountability and Liability of the Responsible Person

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