Cannabinoid Drugs, Medicinal Cannabis & Opioid Drugs
Fangda Partners / China
Cannabinoid drugs, medicinal cannabis & opioid drugs in India – a comprehensive legal overview. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99.
CANNABINOID DRUGS
1. Are Cannabinoid Drugs authorized in your country?
Cannabinoid Drugs are not authorized in China.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
N/A
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
N/A
4. Which are the cannabinoid drugs that have received market approval to date?
N/A
5. Who can prescribe Cannabinoid Drugs?
N/A
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
N/A
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
N/A
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
N/A
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?
N/A
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
N/A
11. When are they likely to come into force?
N/A
MEDICINAL CANNABIS
12. Is Medicinal Cannabis authorized in the country?
Medicinal Cannabis is not authorized in China.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
N/A
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
N/A
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
N/A
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
N/A
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
N/A
18. How can patients obtain Medicinal Cannabis?
N/A
19. Who can prescribe Medicinal Cannabis?
N/A
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
N/A
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
N/A
22. Where is Medicinal Cannabis available?
N/A
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
N/A
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
N/A
OPIOID DRUGS
25. Are Opioid Drugs authorized in your country?
Yes, quite a few Opioid Drugs have been authorized in China, such as Morphine, Remifentanil, Buprenorphine.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
National Medical Products Administration (hereinafter referred to as “NMPA”).
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Currently, there is no specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs. But there is a special regulation named Regulation on the Administration of Narcotic Drugs and Psychotropic Drugs (麻醉药品和精神药品管理条例) promulgated in 2005, later modified in 2013 and 2016, which regulates the planting, clinical study, business, use, storage, and transportation of narcotic drugs (including Opioid Drugs)and psychotropic drugs.
28. Which are the Opioid drugs that have received market approval to date?
Quite a few Opioid Drugs have been authorized in China, such as morphine, Remifentanil, Buprenorphine.
29. Who can prescribe Opioid Drugs?
Practicing physicians.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
N/A
31. What approvals or notifications are required to prescribe Opioid Drugs?
The physicians are required to obtain the qualification for prescribing narcotic drugs and the psychotropic drugs of category I in order to prescribe Opioid Drugs.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Only drug distribution companies with the specific approval for the distribution of narcotic drugs (including Opioid Drugs) and psychotropic drugs are authorized to distribute Opioid Drugs to medical institutions such as hospitals and clinics. No Opioid Drugs can be sold through retail.
33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?
N/A
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
N/A
35. When are they likely to come into force?
N/A
