illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

1 March 2022

Focus on ensuring a high and reproducible quality of medicinal cannabis

Currently in the EU only national pharmacopoeia monographs are available for Cannabis Flower and Cannabis Extracts. Therefore, harmonized European Pharmacopeia monographs for flowers and extracts would be beneficial to obtain equal quality requirements within Europe, especially in terms of import and export. European Medicines Agency Committee on Herbal Medicinal Products (HMPC), responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of the European market, noted three new European Pharmacopeia (Ph. Eur.) Cannabis Monographs for flowers and extracts in the pipeline; Cannabis flos, Cannabis extractum siccum and Cannabis extractum spissum. Once monographs have been elaborated, they will be published for public comment in Pharmeuropa.

The United States Pharmacopeia (USP) currently holds two official monographs for Dronabinol and Dronabinol Capsules and a new monograph for Cannabidiol (CBD) that is currently being developed was just published in the current issue of Pharmacopeial Forum (January 2022). The newly drafted and proposed monograph aims to provide specifications for highly purified CBD from Cannabis sativa. To differentiate the naturally derived CBD from synthetically derived CBD potential synthetic substances are included in the tests for organic impurities besides the natural impurities.

In Canada, the Standards Council of Canada (SCC) will lead an ISO international working group to develop guidelines for the global legal cannabis market. The technical guides will cover the safety, security and sustainability of buildings, facilities, equipment, and systems utilized for the cultivation, production, processing, transportation and sale of cannabis and cannabis products. The three proposed documents to be compiled by ISO IWA 37 working group are:

  • Technical guide for the safety of cannabis buildings, equipment and oil extraction operations;
  • Technical guide for the secure handling of cannabis and cannabis products;
  • Good production practices (GPP) guide for cannabis.

In addition, the American Society for Testing and Materials (ASTM) is working on the elaboration of technical Cannabis standards. The focus of ASTM Committee is to develop standards for cannabis, its products and processes including the development of test methods, practices and guides for cultivation, quality assurance, laboratory considerations, industrial hemp, devices, packaging and security.