As 2024 draws to an end, it has been a mixed year for the global cannabis industry. The standout event was the implementation of the new German Cannabis Control Act (CanG) in Germany, which represents significant and symbolic progress being made by one of the largest economies in the world, and a key leading figure in Europe. Already one of the largest importers of cannabis in the world, the new regulation has seen an explosion in patient demand for medical cannabis, which global exporters are racing to meet.
Elsewhere, a ballot initiative in Florida narrowly failed to pass which would have legalised adult-use cannabis in the state. With the fourth-largest gross domestic product (GDP) of any US state, it would have represented a significant new market for the industry. In terms of federal regulations in the US, the rescheduling of cannabis and/or the Secure and Fair Enforcement Regulation Act (SAFER Banking Act) are expected to progress in 2025, although there have been setbacks in their development in late 2024.
Medical cannabis markets across the world are seeing a common trend towards the development of telemedicine use for cannabis with private, cannabis-specialised clinics extending the reach of small pools of prescribing doctors to large numbers of patients across their respective countries. With significant political change occurring in many of the largest economies in the world in 2024, including key countries for the cannabis industry like the United States, the United Kingdom and Germany, there are new policy approaches coming down the line. Keeping a close eye on how these policies are being developed will be essential to identifying where the potential pitfalls and opportunities of the new-look global landscape will be.
Setting the Boundary: Linnea’s Milestone Cep Application for Its Cannabidiol (CBD) API
Cannabidiol is a powerful therapeutic tool with increased popularity, administered to fragile people in need of the highest quality as possible: the new European Pharmacopeia (EP) dedicated Monograph is now setting the line.
Cannabidiol EP Monograph to void grey areas
Cannabidiol history started with the pioneering view of passionate doctors and researchers back in the 60s. In 2018, it reached orphan drug status, allowing regulatory authorities to start working on a standard to help patients getting the suitable quality for medical cannabis, provided through transparency and with the highest level of technological progress behind. In a spontaneous market, interacting with people affected by diseases even severe, having a guideline for manufacturers dictated by one of the most eminent regulatory bodies worldwide, the EDQM, is the only way to guarantee therapeutic consistency and is by far no more a need, rather an obligation.
In 2024 the official Monograph on CBD was issued by EDQM, and Linnea fully complied with the specifications of its Cannabidiol (CBD) API. Consequently, in September 2024, Linnea was one of the first companies in the world to submit its Certificate of Suitability (CEP) application for its CBD API to EDQM.
Linnea’s commitment to absolute quality, rigorous working methods and compliance with the Swiss and international standards for pharmaceuticals have been a signature of all its products, making the company name synonymous with leadership and reliability. The publication of a dedicated Monograph for Cannabidiol Isolates in the European Pharmacopoeia in July 2024 was then the best opportunity to apply all this expertise: a CEP application for its Cannabidiol API was for Linnea a natural step forward, as a Drug Master File (DMF) on CBD comes with the substance since 2019.
What is a CEP?
A Certification of Suitability (CEP) attests to the strictest conformity of a specific API with the standards presented into a Monograph of the European Pharmacopoeia (EP). When applying, the manufacturer of the API provides evidence that the quality of the ingredient is in accordance with the EP monograph and, if approved, such certification is granted by the European Directorate for the Quality of Medicines (EDQM). While the adherence to the Monograph is mandatory, the CEP is a further guarantee, facilitating all the manufacturers and the suppliers that wish to sell their drugs in Europe, and it promotes trust among healthcare professionals and stakeholders. Moreover, it simplifies and speeds up regulatory and administrative processes in the countries where it’s recognised.
CEP benefits for stakeholders
CEP is just one of the certifications Linnea can provide to its B2B customers. Pharmaceutical companies that purchase Linnea’s active ingredients can count on a reliable, regulatory-compliant supply chain, which speeds up any necessary approvals for the sale of final products destined for use among the public. In fact, CEPs are accepted by the 39 signatory states of the European Pharmacopoeia and a bunch of other countries outside the EU, such as Australia, Canada, South Africa, and Saudi Arabia, opening the doors to product commercialisation worldwide. Likewise, regulators will benefit from a simplification of compliance assessments and verifications, giving rise to greater efficiency.
Cannabinoids: a complex global market
In recent years, there has been marked interest by consumers in the potential benefits of Cannabinoid-based extracts and isolates, leading to growing demand in such APIs in the pharmaceutical, cosmetic and nutraceutical industries. Due to the lack of a regulatory framework, a fast-changing and disjointed landscape has risen worldwide, leading to several different requirements to enter single national markets, sometimes with unclear rules.
The CEP guarantees a faster way during a registration process and, even if the current medical cannabis market is pretty galenic, with small bulks provided to pharmacies with “agile” GMP quality, some European country is working to make cannabis exiting its undefined status and reaching the requirements needed for all the other drugs. The most recent French Cannabis regulation draft foresees to file products through a standard CTD (Common Technical Dossier) model, meaning that the Cannabidiol used will need not only the compliance to the European Pharmacopeia rules and the Cannabidiol Monograph but also a complete Drug Master File with at least 6 months ICH stabilities.
In such a fractured market, Linnea is committed to provide certifications which guarantee quality, precise percentages of active ingredients (and the lack of unwanted substances), long-term ICH stabilities in the final container and run in many climatic zones and ethical cultivation practices as paramount. The Linnea® Cannabinoids line has been developed to make the life of companies willing to market cannabinoids in Europe and Worldwide easier.
Conclusion
Linnea’s Cannabidiol Isolate API CEP application is a concrete demonstration of its commitment to quality, the latest in the company’s long list of compliance certifications. Such adherence to strict guidelines and best practices, a guarantee of rigorous testing of its active pharmaceutical ingredients, reinforces Linnea’s role as a dependable partner and pioneer in the Cannabinoid API market, today and tomorrow.
Want to learn more?
• Explore Linnea’s Cannabinoid portfolio:
• Get in touch with our team of experts to learn more about
Linnea’s high-quality Cannabinoid APIs: sales@linnea.ch
