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.
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.
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.
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.
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.
Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures, the EDQM published some examples to provide users with practical guidance. How can the critical factors potentially affecting the analytical procedure performance be identified?
ANVISA´s Q&A on Medical Cannabis for Clinical Investigations
The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. One of the important questions addressed is: How can batch reproducibility be demonstrated?
The EMA Committee on Herbal Medicinal Products (HMPC) published the minutes for the HMPC meeting held in May 2022. The Meeting Protocol contains several interesting developments regarding Cannabis. Will it be possible for regulatory submissions to use the well-established medicinal use pathway in the EU?
