To GMP or not to GMP
Within the cannabis industry, there are some clear advantages to being GMP (Good Manufacturing Practice) certified. Further, having a good understanding of these GMP regulations is highly beneficial when it comes to bringing cannabis products to market. Whether a company embraces GMP or not will be determined by many factors, including the products the business wishes to produce, what jurisdictions those products will be sold in, and cost. To better understand the implications of GMP certification one must carefully assess the advantages and disadvantages.
Although GMP can be a complex and time-consuming process, some distinct advantages that GMP certification can offer are;
- Increased product credibility and consumer assurance that a product has been manufactured to the highest quality standards;
- A competitive advantage in the marketplace over non-GMP certified products;
- Decreased time and cost barriers for companies searching for certified contract processors;
- Reduced costs and increased efficiencies associated with rework and penalties due to non-compliance;
- Increased confidence of a manufacturer’s management team in the preparedness of manufacturing facilities for inspection and confirmation of the maturity of their quality program.
Even with the benefits GMP certification can bring to a business, it is imperative to understand certification and compliance requires significant investments of time, money, and personnel. These factors can be substantial hurdles in obtaining certification, particularly for smaller businesses.
GMP & Jurisdictional Authority
Notwithstanding the advantages listed, whether a company decides to pursue GMP certification comes down to the market in which they want to sell their products. If a medical cannabis supplier or manufacturer has decided to become GMP certified, then they must meet GMP regulations for the jurisdiction(s) in which they wish to sell their product.
For example, an American pharmaceutical manufacturer wanting to sell their products in the USA and the EU must be GMP certified in both those jurisdictions. Although authorities in different regions – including Canada, the USA, and the EU – have historically developed and enforced their own GMP regulations, there has been momentum in the last few decades to harmonise these guidelines. This typically happens through Mutual Recognition Agreements (MRA) and the establishment of organizations like the International Conference on Harmonisation (ICH).
An MRA, as it relates to GMP, is an international agreement aiming to deliver greater market access and coordination of regulations while maintaining consumer safety. These agreements allow authorities in two different jurisdictions to rely on one another’s GMP inspections, share audit information and quality defects, and reduce or eliminate the testing of products upon import into their regions of authority.
The Markets and EU GMP
The EU is unique with its current regulatory framework for cannabis. Currently, no member states permit legal recreational markets, though a handful have passed legislation to allow access to medicinal products. Jurisdictions that have introduced some form of medical cannabis regimes – including Germany, Denmark, and Malta – have called for all products to be cultivated and processed in accordance with EU GMP standards. As these guidelines have already been established for pharmaceutical products, most countries pursuing medical cannabis laws are also accepting them. More demanding than any other cannabis manufacturing regulations in the world, the EU has set the tone for where the market is heading in the future.
Despite the European Parliament passing a resolution in February 2019 calling on the European Commission (EC) to harmonize cannabis regulations across the EU, there is no central regulation or guidance on cannabis products in the region. This means that businesses wishing to sell or produce cannabis products in the EU must do so in a member state that permits such activities. However, based on the number of EU member states that have already implemented medical cannabis programs, it is likely the EC will provide region-wide direction on medical cannabis in the near future.
Since the EU has such huge market potential, with some estimates suggesting that by 2028 the medical cannabis market could be worth CAD$185 billion, cannabis cultivators and processors around the world are moving towards EU GMP certification in order to gain access. The EU has MRAs with many other countries in the world including Canada, Australia, New Zealand and Japan. If cannabis cultivators and processors gain EU GMP certification then they can potentially leverage the MRAs to gain access to these other markets. It is very important to note that medical cannabis is not currently included in the scope of these MRAs, but this may change in the future as more countries adopt medical cannabis programs and look to import and export these cannabis products. Furthermore, the USA has yet to fully harmonize or share in these MRAs with the EU for drug products.
The implementation of GMP is becoming crucial within the cannabis industry to align international market participants to known standards and regulations for medical products, all for the safety of the end consumer. This will allow much greater market access for any business involved in medical cannabis, from suppliers to manufacturers. Still, it is important to note that as GMP certification covers all aspects of production – from starting materials and premises, to the equipment being used and the training and hygiene of staff employed there – it is beyond the scope of many smaller businesses. However, it does appear that GMP certification will become the norm for medical cannabis products, and (as mentioned in Part 1) lack of compliance could become a reason for restricted access to some markets and/or loss of sales. The last part of this series on GMP will cover how to get ready for GMP certification and go into further detail on how to achieve certification and what it covers.
For a full introduction to GMP, feel free to view our recent GMP Webinar: Part 1 presentation here. And if you haven't already, sign up for our monthly newsletter to stay in touch and up to date with all of our ongoing extraction education.