Japan
Japan, known for its conservative stance towards cannabis, surprised the global cannabis industry in December 2023. The Japan Diet passed the ‘The Amending Law’ updating the Narcotics and Psychotropic Control Act and Cannabis Control Act, renaming them as ‘The Cannabis Plant Cultivation Regulation Act’, designed to create a framework for pharmaceutical cannabis, CBD products, and hemp cultivation in the country.
The amendments to the Narcotics and Psychotropic Control Act will seek to regulate the use of cannabis-based pharmaceutical medicines domestically (currently its use is only approved for clinical trials). They will also close a current loophole which would criminalise the ‘use’ of cannabis (previously only the possession, distribution, transferring, and importation was illegal, not its use ) and categorise THC as a narcotic. The Amending Law also seeks to create a clear regulatory framework for hemp cultivation and CBD products which may continue to fuel Japan’s already growing CBD market.
Following the bill’s passing the Japanese government announced a ‘year of promulgation’ in which details would be fleshed out by experts and government officials. These amendments to the law would be implemented in two phases with the first amendments regarding pharmaceutical cannabis and CBD products set to come into effect on 12 December 2024 and changes to the hemp cultivation regulations in 2025.
Pharmaceutical Cannabis
As of November 2024, the use of pharmaceutical cannabis based medicines remained limited to clinical trials, however, this changed on 12 December 2024 when the amendment of the Narcotics and Psychotropic Control Act came into effect. One of the few clinical trials in Japan regarding cannabis-based pharmaceutical medicines, GW Pharmaceuticals’ (owned by Jazz Pharmaceuticals) Epidiolex, was approved to examine its effects on epileptic patients with Dravet Syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex. Phase 3 of the clinical trial started in December 2022, however, on 22 August 2024, the company announced that it had failed to meet its, ‘primary efficacy endpoint of a pre-specified percentage change in indication-associated seizure frequency during the treatment period (up to 16 weeks) compared to baseline in Japanese pediatric patients’. However, the company did find numeric improvements in primary and secondary end-points and stated that they will continue to engage with regulatory authorities regarding a new potential drug application.
The Amending Law, which came into effect in December 2024, classifies all cannabinoid products that contain more than 10ppm THC as a narcotic while removing the prohibition of cannabis- based pharmaceutical medicines by categorising them as narcotics with potential medical application, thereby opening the avenue for pharmaceutical companies to manufacture and sell pharmaceutical cannabis-based medicines in Japan once authorities have approved a product for their efficacy and safety. This provides an avenue for doctors to prescribe authorised cannabis pharmaceuticals to patients in the future.
CBD
It is estimated that roughly 150 companies are either manufacturing, distributing, or importing CBD products in Japan. The main sales channels for these products are on online marketplaces such as Rakuten and Amazon, as well as department stores, speciality retailers and wellness boutiques selling a range of edible, beverages, wellness, and vape products. Currently, no observable trace, (however with no specified amount) of THC is allowed in CBD products with the market dominated by CBD isolates and broad-spectrum products. With the new amendment, the country will be one of the first in the world with a detailed CBD product framework which would only allow minuscule traces of THC in products as well as allowing CBD in foods, without the need for prior approvals as seen with Novel Food in Europe.
Between May and June 2024, the Ministry of Health, Labour and Welfare (MHLW) launched a public comment period of their initial proposal allowing industry stakeholders to include their input on the upcoming CBD framework. Many of the stakeholders during this period raised concerns that the THC limits and product definitions were too strict and unclear which could negatively impact the market. However, in October 2024, the MHLW released a further ordinance containing detailed definitions of oils and powders, Certificates of Analysis (COA) and product guidelines as well as keeping the THC threshold limits the same.
‘The Ministry of Health, Labor, and Welfare (MHLW) envisions the distribution of cannabis-derived products as prescription drugs, such as the Epidiolex prescription for intractable epilepsy, and has not considered the creation of a “medical cannabis system” like those functioning in the states of the US. Encouraged by the requests of patient groups and the President of the Japanese Clinical Association of Cannabinoids, Dr. Ichiro Takumi, a member of the Diet, Kozo Akino pursued the issue of patient rights as a question to MHLW in the Diet. The Ministry of Health, Labor, and Welfare (MHLW) proposed a remedy for patients with intractable epilepsy: CBD products containing THC could be prescribed within the framework of research. This is called a specific clinical study and is expected to begin within the year.’
Dr Yuji Masataka, MD, Japan’s Medical Cannabis Specialist
MHLW ORDINANCE CATEGORIES AND THC LIMITS*
Oils &Fats
- Definition: The solvent used needs to contain more than 90% of compounds formed by the combination of glycerin and fatty acids and must be in liquid form at room temperature (15-25°C)
- THC Limit: 10ppm
- Product Examples: CBD oil, hemp seed oil, cosmetic oil, etc. [vegetable oils]
Powders
- Definition: Substances with a particle size smaller than coarse powder as defined in the Japanese Pharmacopeia
- THC Limit: 10ppm
- Product Examples: CBD isolate powder, CBD protein powder etc.
Water Solution
- Definition: Liquid that is water with substances dissolved or dispensed
- THC Limit: 0.1ppm
- Product Examples: Soft drinks, alcoholic beverages, skin lotion, milk/plant-based drink
Others
- Product Examples:
- Confectionary, tablet, butter, etc. (Solids)
- Electronic cigarettes, etc. (Compounds made of glycerin and fatty acids, organic solvent products that do not contain water)
- Shampoo, conditioner, cosmetic lotion, cream, balm, mayonnaise, dressing, etc. (High viscosity or high content of compounds that combine glycerin and fatty acids, or mixture of both with water)
- Jelly, etc. (Gel-like semi-solids that contain no processed products and are made of glycerin and fatty acids)
- THC Limit: 1ppm
*For CBD-related products refer to products containing CBD (Cannabidiol), CBN (Cannabinol), or CBG (Cannabigerol)
Although the ordinance sets very strict THC limits and restrictive definitions of what constitutes a certain product, such as powder being defined as particles smaller than coarse powder, this outline is a global first for the CBD industry as it provides clear details on what constitutes a legal CBD, CBN and CBG product (vape, edible, beverage, oil etc.) specifically into law. It can also be said that this ordinance provides the Japanese CBD market with an advantage as it provides clarity of what products companies are allowed to manufacture, import and distribute, compared to European markets where CBD product laws are very unclear.
‘This framework is another opportunity for the Japanese market, as it provides us and the authorities with clear compliance guidelines, eradicating the grey market and allowing businesses to streamline their supply chains. Edible forms of CBD are also one of the most purchased products in Japan, as these guidelines allow us to have CBD in foods, Japan is more progressive in that sense to European markets.’
Astrasana Japan’s CEO Chikako Yoshida
Thailand
While campaigning for the 2023 election, Thailand’s ruling Pheu Thai party declared their intention to reclassify cannabis as a narcotic in Thailand. This remained the official position of the party, and the government, until political turmoil saw the reshaping of the Thai cabinet in August 2024, with a new prime minister and a more significant role for the Bhumjaithai Party (BJT) party, the party responsible for initially pushing for cannabis reform in 2018.
Given the more significant position of the BJT in the ruling coalition in Thailand, the government now intends to establish a more detailed and controlled regulatory structure for the cannabis industry in the country, rather than reclassifying it as a narcotic.
The cannabis industry in Thailand is currently in a state of chaos. Beyond limitations on those who are permitted to consume it, the market is a free-for-all. Technically, only Thai nationals are permitted to cultivate, extracts of cannabis should still be controlled as narcotics, and all cannabis should be grown in Thailand by registered companies.
In practice, the industry is saturated with cheap imports from neighbouring countries and cultivation from unregistered organisations, and there is no system of regulation in terms of the supply chain. Extract-based products are sold freely, and the only differentiating factor between all products is price, due to the absence of any form of quality control or standardisation. The result is a race to the bottom in price, which has negative consequences on product quality and safety.
There are large numbers of dispensaries selling cannabis, with tourists representing the most significant customer base. It is difficult for any store, cultivator or brand to attain significant market share, because there is little brand recognition or product differentiation.
The medical community in Thailand has turned against the possibilities which cannabis offers because of the chaos of the cannabis market, and its product quality issues – with products often containing levels of heavy metals, pesticides, and other contaminants.
The new regulations intend to create a licensed system. Cultivation, manufacture, distribution and retail will only be done under licence, and must be compliant with the relevant standards – e.g. good agricultural and collection practices (GACP) for cultivation. However, in its current form, the new legislation does not include mandatory track-and-trace infrastructure, nor a system for comprehensive lab. testing, so compliance will be difficult to enforce along the supply chain.
What seems likely is that there will be a proper system of control for retail. Retailers will only be able to operate under licence, and with the supervision of a doctor trained in traditional Thai medicine. The large number of unregulated retailers will be reduced to a smaller number of controlled retailers, and the government will be able to realise some of the tax revenue which is not currently being collected.
It is also possible that this will be the first step in eventually regulating the supply chain effectively. If retail is properly controlled, then authorities could potentially work backwards along the supply chain, and make sure that each step is fully licensed, standardised and controlled.
The establishment of a legitimate system of regulation for the cannabis industry would also allow greater opportunities for Thai cultivators to export abroad. Cannabis grown under internationally recognised standards would be eligible for export, and the country could participate in the global medical supply chain.
The new regulations are currently being worked on, following a consultation period on a draft version of the legislation. The government intends to pass the legislation and implement the new structure in 2025.
