GMP News - Herbal Medicinal Products (incl. Cannabis)


St. John´s Wort: Updated EU Herbal Monograph

The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.



Declaration of Herbal Substances & Herbal Preparations in HMPs

The HMPC issued a concept paper on the revision of the Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products (HMPs).



FDA´s Guidance on Quality Considerations for Clinical Research with Cannabis

The FDA published the final guidance on Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.



EMA's Q&A on Medicinal Cannabis & Call for Scientific Data

The HMPC adopted a Question & Answer (Q&A) document regarding medicinal products. The document aims to clarify the basic regulatory requirements for stakeholders that may not have extensive experience with the EU pharmaceutical regulatory system. In addition, the EMA started a call for scientific data in order to establish an EU herbal monograph.



Denmark provides further Guidance on Medical Cannabis

The Danish Medicines Agency has prepared a new guidance for the pilot programme on cannabis products. Amongst others, the document contains GMP and other quality requirements for Danish-made cannabis products.



The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?



FDA concludes that existing Regulatory Framework is not applicable for CBD

The U.S. FDA has concluded that a new regulatory pathway for CBD is needed that balances the desire for access to CBD products with the regulatory oversight needed to manage risks.



Does Heating in a Vaporizer Reduce the Microbial Load in Cannabis?

There is currently an ongoing discussion about the microbiological quality requirements for medical Cannabis depending on the route of administration. To move forward authors from the FDA recently published an article about a microbiological study of bulk Cannabis.



Australia Amended its Cannabis Regulation regarding GMP Requirements

Australia´s Therapeutic Goods Administration (TGA), which regulates Medicinal Cannabis in Australia, has put out its latest Compilation regarding the production and import regulations (TGO 93). As of July 2023, all imported medicinal cannabis products released for supply in Australia will have to present evidence to be produced under GMP.



ANVISA authorizes National Scientific Research with Cannabis

The agency now authorizes national scientific research with cannabis-derived products. The authorization granted will allow to conduct pre-clinical research to evaluate the efficacy and safety of cannabinoids in the management of signs and symptoms associated with neurological and psychiatric disorders.



Warning Letters for Companies selling CBD containing Food and Beverages

The U.S. FDA warns five companies for illegally selling food and beverage products containing cannabidiol (CBD). According to the agency, the use of CBD raises safety concerns, especially with long-term use.



How does the MHRA approve Manufacturing Authorizations for Cannabis Products?

An increasing number of companies with no previous GMP experience are entering the pharmaceutical sector to cultivate, process and manufacture medical cannabis products. Therefore, the MHRA recently posted how the required licences are granted by the agency.



Ph. Eur. Cannabis Monograph Proposed for Comment

The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs.



Revised Ph. Eur. Chapter on Foreign Matter

The final version of Ph. Eur. 2.8.2 Foreign Matter in herbal drugs has been published in Ph. Eur. 11.1. The revised chapter clarifies that the quantitative limits for foreign matter only apply to foreign organs and foreign elements; other foreign elements should, as far as possible, be absent.



USP publishes proposed Cannabis Monograph

A proposed monograph for Cannabis Species Inflorescence has been published in the USP Herbal Medicines Compendium (HMC). It is open for public comments for 90 days.


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