What are the main challenges you see for cannabis companies when it comes to integrating into pharmaceutical regulations?

The pharmaceutical industry is one of the most regulated, not only in Spain but also in other international markets, with the European Union, along with countries like the UK, USA, Canada, or Japan, being one of the globally most demanding regulatory environments.

Pharmaceutical regulation primarily applies to the medication itself. In order to obtain marketing authorization, it is subject to a specific legal framework depending on the type of product, with the aim of ensuring quality, safety, and efficacy.

Similarly, pharmaceutical regulation applies to each entity involved in every stage of the drug’s value chain, from the production of the active ingredient to the distribution of the medication, including its formulation and packaging. At each of these stages, compliance with specific regulations is required, all aimed at ensuring the quality, safety, and efficacy of the drug, in accordance with the conditions outlined in the product’s marketing authorization.

Specifically, for the production of medications derived from plants, such as medicinal cannabis, GACP regulations must be adhered to during planting, cultivation, and harvesting. Additionally, GMP regulations apply during post-harvest processing activities, including the processing of plant material, extraction and purification of active compounds, as well as the formulation, dosage, and packaging of the medication.

At this point, the most significant challenges that must be faced in the production of cannabis-derived medications include the following:

• Designing facilities, equipment, and systems suitable for the activities to be carried out, which, on the one hand, meet the specific operational needs of each company and product, and on the other hand, provide the appropriate level of compliance with the applicable regulations at each stage of the process (GACP or GMP as applicable).
• Developing robust and reproducible production processes, considering the intrinsic variability of any living organism and the regulatory requirements related to process validation, process control strategy, and quality specifications outlines in official Pharmacopoeias, when applicable (such as the monographs in the European Pharmacopeia for extracts and herbal medicines, or more specifically for cannabis flower). Of course, the quality of starting materials and the inputs required for the process, as well as the qualification of personnel involved in operations, are key elements that must be controlled to ensure the performance of the process with established limits.
• Implementation of an appropriate Quality Management System in accordance with international guidelines and standards, based on the principles of Risk Management, traceability of all operations, and data integrity. This system should ensure the state of control and comprehensive knowledge of the process, serving as a framework for continuous improvement. It should provide suitable tools for managing change in an organized and structured manner, as well as for managing quality defects to ensure the investigation of all critical defects and the conduct of effective root cause analyses.
• Additionally, in cannabis-derived medications, an additional layer of regulation is added due to the fact that they are narcotic products. Therefore, having the necessary security elements in the facility, designed based on a prior risk assessment, is of vital importance. Likewise, the entire production and distribution process must have appropriate systems and controls to ensure product traceability at all times.

Therefore, success lies in addressing, in a combined manner, the challenges posed by the cultivation and processing of this plant, as well as the subsequent extraction and purification of its active principles for the formulation of medications. This involves meeting the regulatory requirements applicable to this industry, which demand a high level of knowledge and specialization. These requirements present technical and organizational needs that impact the company’s viability from a legal and administrative standpoint.