Last year we heard about Pharmacopoeia drafts for medical cannabis in Germany. Pharmacopoeia is a book written by the authorities which includes guidelines for identifying chemical medicines. These guidelines are also known as monographs. It also contains the necessary reagents and reference standards for their procedures. There are Pharmacopoeias on a country level, as German one for example, or respectively like EDQM – for Europe.
Cannabinoids in Germany ‘s Pharmacopoeia
The German Federal Institute for Drugs and Medical Devices issued an important announcement on May 15 regarding the German Pharmacopoeia 2023. On August 1, 2023, the revised version—also known as the German Pharmacopoeia 2023 (DAB 2023)—will go into effect. The announcement also involves the release of the text and monograph headings.
The two monographs Cannabis Flower and Cannabis Extract currently appear in the Germany ‘s Pharmacopoeia (Deutsches Arzneibuch, DAB). Reference substances for cannabis are essential for assay and purity tests, as well as for identity tests (TLC), specified therein. The Expert Committee for Pharmaceutical Biology has suggested, however, to update reagent descriptions. A result of this was the updating of the monographs on cannabinol, cannabidiolic acid, cannabinol, 8-tetrahydrocannabinol, 9-tetrahydrocannabinol, and 9-tetrahydrocannabinolic acid.
The monograph was part of revision. According to specialists, 13C-NMR data can be used instead or in addition to 1H-NMR data for identification. Before, chemicals had to pass 13C-NMR and 1H-NMR tests.
Their revisions will be part of the German Pharmacopoeia 2023 (DAB 2023). The updates take into account the latest developments in science as well as quality and safety requirements for pharmaceutical preparations.
Cannabis in Pharmacopoeia – conclusion
In the European Pharmacopoeia (Ph. Eur.), there are currently no reference substances for cannabis analysis provided. This Pharmacopoeia is actively working on its cannabis monographs.
The inclusion of these substances and monographs in the updated version shows the commitment of the German Pharmacopoeia Commission to providing up-to-date and accurate information for the pharmaceutical industry, ensuring the quality and effectiveness of medicinal products. Therefore, in terms of Pharmacopoeia, we can recognize medical cannabis as a “drug” in Germany.
It is crucial to confirm compliance to the most recent regulations and norms listed in the Pharmacopoeias. However, pharma companies have to be compliant with GMP standards as well.