USP Publishes Draft on Quality Requirements for Cannabis
The USP previously announced to elaborate a chapter on quality considerations for Cannabis. Now the draft chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research has been published in PF 49.3. Comments can be sent to the USP until end of July.
The U.S. Food and Drug Administration (FDA) has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP). Now the agency announced a virtual public meeting on Good Manufacturing Practices (GMP) for Cosmetic Products to be held in June this year.
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).
The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.
Hop (Humulus lupulus) is commonly known for its use in brewing beer. However, it is also used as a herbal drug. The Ph. Eur. Monograph Hop Strobile has now been proposed for revision.
The International Pharmacopoeia (Ph. Int.) is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation. Now, the 11th Edition of the Ph. Int. has been published.
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.
