Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Nishimura & Asahi / Japan
Keen to learn more about cannabinoid drugs, medicinal cannabis and opioid drugs in Japan? Read on! Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
No. In Japan, usage of cannabis (all kinds) is severely restricted by two acts. The first is the Cannabis Control Act, under which “Cannabis” is defined as the cannabis plant (Cannabis Sativa L.) and its products; provided, however, that the grown stalk of the cannabis plant and its products (excluding resin) and the seed of cannabis plant and its products are excluded. The Cannabis Control Act prescribes that any person who is not a cannabis handler (“cannabis handler” includes cannabis researchers) must not possess, cultivate, receive, transfer cannabis or make research use of it. Furthermore, it is prohibited for any person to perform any treatment with medicines manufactured from cannabis or distribute it for treatment, and to receive treatment with any medicines manufactured from cannabis.
The second act is the Narcotics and Psychotropics Control Act. The purpose of this Act is to prevent any health and sanitation hazards caused by the abuse of narcotics (and psychotropics). Cannabis itself is not covered under the act, but tetrahydrocannabinol (THC), a major cannabinoid of cannabis, is regulated as a narcotic under the act provided it is chemically synthesized.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
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3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
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4. Which are the cannabinoid drugs that have received market approval to date?
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5. Who can prescribe Cannabinoid Drugs?
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6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
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7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
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8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
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9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
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10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
No. There is currently no noticeable movement for reform or significant change to the regulation of Cannabinoid Drugs.
11. When are they likely to come into force?
N/A
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
Regardless of name or purpose, usage of all types of cannabis is banned by the Cannabis Control Act unless it is made from grown stalks or seeds of cannabis plant (refer to Q1). One exception, however, is cannabis researchers (persons that receive licenses from the prefectural governor and cultivate cannabis plant with the purpose of researching cannabis or uses of cannabis). They are permitted to possess, cultivate, receive, transfer cannabis or make research use of it. Additionally, cannabis researchers are allowed to import cannabis to Japan only if they satisfy certain requirements (refer to Q15).
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
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14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
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15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Under the Cannabis Control Act, it is prohibited to import cannabis. However, cannabis researchers who have received authorization from the Minister of Health, Labour, and Welfare (“MHLW”) to import cannabis are excluded from this prohibition.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
Registration as a cannabis researcher is the first requirement. Moreover, to import cannabis, it is also necessary for cannabis researchers to receive authorization from MHLW.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
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18. How can patients obtain Medicinal Cannabis?
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19. Who can prescribe Medicinal Cannabis?
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20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
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21. What approvals or notifications are required to prescribe Medicinal Cannabis?
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22. Where is Medicinal Cannabis available?
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23. Is there a list of retailers authorized to sell Medicinal Cannabis?
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24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
No. There is currently no noticeable movement for reform or significant change to the regulation of Cannabinoid Drugs.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Some Opioid Drugs are authorized as legitimate pharmaceutical products for sale based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Additionally, in Japan, most Opioid Drugs are treated as narcotics under the Narcotics and Psychotropics Control Act. Therefore, as long as the requirements are satisfied, Opioid Drugs may be medically prescribed and distributed in compliance with the stringent regulatory framework established by the act and its related regulations.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
The main authority with jurisdiction over Opioid Drugs is MHLW. Prefectural governors and the head of the respective Regional Bureau of Health and Welfare are also involved in issuing some licenses.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Opioid Drugs can be authorized for sale in Japan once they have successfully completed the review process in accordance with the applicable requirements under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and its regulations.
There is no specific regulatory framework for the pricing, and reimbursement of Opioid Drugs in Japan.
28. Which are the Opioid drugs that have received market approval to date?
Some Opioid Drugs have already received market approval. They include morphine, oxycodone, fentanyl, methadone, hydromorphone, codeine, and dihydrocodeine. Please note that these Opioid Drugs are designated as narcotics under the Narcotics and Psychotropics Control Act.
29. Who can prescribe Opioid Drugs?
It is essentially prohibited for any person that is not a Person Licensed to Administer Narcotics to administer a narcotic, deliver a person a narcotic to administer, or deliver a prescription for a narcotic. A “Person Licensed to Administer Narcotics” means a person that, in the course of business and as treatment for an illness, administers narcotics, delivers a person a narcotic to administer, or deliver prescriptions for a narcotic, having already been licensed to do so by the prefectural governor. It is not permissible for a person other than a physician, dentist, or veterinarian to obtain licensing as a Person Licensed to Administer Narcotics.
30. Is there a list of entities authorized to prescribe Opioid Drugs?
No. There is no public list of licensed doctors authorized to prescribe Opioid Drugs as a Person Licensed to Administer Narcotics in Japan.
31. What approvals or notifications are required to prescribe Opioid Drugs?
Persons Licensed to Administer Narcotics may prescribe Opioid Drugs without additional approval or notification. Please note that a Person Licensed to Administer Narcotics must not administer a narcotic, deliver a narcotic to administer, or deliver a prescription for a narcotic for any purpose other than treatment for an illness.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
It is essentially prohibited for any person that is not a Commercial Narcotics Handler to sell/distribute a narcotic. A “Commercial Narcotics Handler” means a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, Primary Wholesaler of Narcotics, Narcotics Wholesaler, or Narcotics Retailer.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
No. There is no public list of licensed retailers/distributors authorized to sell Opioid Drugs in Japan.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
No. There is currently no noticeable movement for reform or significant change to the regulation of Opioid Drugs.
35. When are they likely to come into force?
N/A
