Developments in Medical Product Regulation Affecting the Cannabis Industry

As a variety of cannabis products are introduced into the medical field, both industry and institutions are facing the challenges of a new, rapidly-evolving policy environment being built on the backbone of an old and strained system of medical regulations.

With new markets opening up to cannabis-based products every day, governments are creating paths to allow patients to access new products without unnecessary delay. On November 1st, the United Kingdom changed its stance on cannabis-based medicinal products (CBMPs) by defining new ways for doctors to prescribe cannabis-based therapies and for manufacturers to place their product on the UK market.

While these exciting developments inject confidence and energy into the sector, they also create unknowns when it comes to their practical interpretation. As prescribers, the industry and intermediaries await the publication of comprehensive guidelines, they all face many uncertainties in this uncharted territory.

Another challenge for manufacturers of cannabis-based products can be the complex system which regulates medical products. Marketing approval processes are designed to ensure the quality, efficacy and safety of and medical products and devices before they are allowed on the market. Some manufacturers may already hold a medical licence in their country of origin, and are new only to the regulatory specifics of the market they aim to enter. Others, who are new to the market or coming from a country where the product is not regulated as a medical product (e.g. as a food supplement, herbal or tobacco product), may be facing these systems for the first time.

In either case, the challenge is three-fold:

1) understanding and complying with the specific established requirements of the target market;

2) navigating the intricate workings of the marketing approval process and working with the relevant competent authorities;

3) staying abreast of changes and trends that are dramatically transforming the regulation of this sector at an international level.

What does this mean for the cannabis industry?

• Documentation and quality requirements: Whether it is a pharmaceutical dossier or a medical device technical file, regulatory submissions in different markets rely on different formats and core documented evidence to support the medical claims and the assurance of quality, efficacy and safety. The use of Good Manufacturing Practice (GMP) guidelines and international standards (such as ISO9001 and ISO13485 for Quality Management, ISO14971 for Risk Management, and ISO14155 for Clinical Evaluation) is homogenising regional differences in requirements, although harmonisation efforts are far from complete. New developments are expected with the advent of the new Medical Device Single Audit Program (MDSAP), which will create a single system of submissions and inspections for valid for five global markets (EU, US, Canada, Japan, Brazil).

• Interaction with regulatory bodies and process requirements: The distinction between which products require GMP certification for pharmaceuticals and which require the European Union’s CE marking for medical devices is beginning to evolve and overlap. One example is devices made for the delivery of a specific drug, such as a vaporiser or an inhaler containing the active substance. In Europe, these products used to be regulated as pharmaceuticals by national competent authorities, but will soon require pre-approval from medical device notified bodies (according to Art 117 of the new Medical Device Regulation).

• Key changes and trends: The new European Medical Device Regulation (MDR) coming into force on May 2020 is bringing significant changes to the drug and device regulatory landscape, and manufacturers must be up to date on the implications for their products, as well as of the strain that this change places on regulatory bodies and their review timelines. Another point worth noting is the growing attention placed on the review of a product's performance once it is placed on the market and used by patients (i.e. post-market surveillance, or pharmacovigilance). The recent Medical Implant Files controversy is both a symptom and driver of this change, and is aligned with the stricter reporting requirements included in the new MDR.

This and more was the focus of the Drug-Device Combination Product Summit attended by our Senior Regulatory Consultant Giulia Paggiola in Berlin on 5-6 December. For more insights and advice on international marketing approval processes and requirements for cannabis-based medicinal products and devices, please get in touch info@hanwayassociates.com.