As an adjunctive treatment for Parkinson’s disease, the accessibility of safinamide in China is a major concern for patients.
I. Domestic Launch Status
1. Not Yet Launched in Chinese Mainland
(1) As of April 2026, safinamide has not received formal approval from the National Medical Products Administration (NMPA) of China, and is therefore not available for sale in Chinese Mainland.
(2) The drug was approved by the U.S. FDA in 2017 and is currently mainly marketed in the United States, parts of Europe, Japan, and other regions.
2. Status in Hong Kong, Macao and Taiwan Regions
(1) Safinamide may be launched in the Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan Region through local drug approval procedures; specific information should be consulted with local medical institutions or pharmacies.
(2) In Hong Kong and Macao, the drug may sometimes be obtained with a specialist’s prescription.
3. Future Launch Prospects
(1) With the growing demand for Parkinson’s disease treatment in China, it is possible that the drug will enter the Chinese Mainland market in the future.
(2) Patients may follow official pharmaceutical news channels for the latest approval updates.
II. Analysis of Purchase Channels
1. Formal Domestic Channels
(1) As the drug is not yet approved domestically, formal hospital pharmacies in Chinese Mainland cannot prescribe or dispense it.
(2) Some large hospitals may apply for temporary importation for specific patients under the “clinically urgently needed imported drugs” policy, which has high thresholds and requires strict eligibility criteria as well as approval from the hospital ethics committee and drug regulatory authorities.
2. Overseas Purchase Channels
(1) Cross-border medical treatment: Some patients choose to seek medical care in countries where the drug is already available (such as the United States, Japan, and European countries) and purchase the drug with a local doctor’s prescription. Attention should be paid to complying with customs regulations when bringing the drug back to China.
(2) Online international pharmacies: A small number of qualified international pharmacies may provide cross-border delivery services. For such channels, it is necessary to verify the pharmacy’s qualification, drug source and transportation conditions.
3. Clinical Trial Channels
If relevant clinical trials of safinamide are conducted in China, eligible patients may enroll after hospital ethical review and receive the investigational drug free of charge.
III. Purchase Precautions
1. Legal and Compliance Risks
(1) Unapproved drugs shall not be sold in China.
(2) Individuals purchasing drugs for personal use from overseas channels must comply with the quantity limits set by the General Administration of Customs on personal-use pharmaceuticals, generally following the principle of “reasonable personal use” and providing a prescription certificate.
2. Authentication of Drug Authenticity
(1) There is a risk of counterfeit drugs when purchasing overseas. Points for attention include:
(2) Checking batch numbers and expiration dates: Regular pharmaceuticals are printed with batch numbers, expiration dates and manufacturing information on the outer packaging.
(3) Keeping purchase vouchers: including invoices, prescriptions, logistics documents, etc., for future inspection.
3. Storage and Transportation Conditions
(1) Safinamide should be stored at a room temperature of 25°C, with short-term temperature fluctuations allowed between 15–30°C.
(2) Exposure to extreme heat or cold during long-distance transportation may affect efficacy. Cold chain or temperature-controlled transportation services are recommended.
4. Medication Safety
(1) Must be used by prescription: This is a prescription drug and should be used under the guidance of a doctor; self-purchase and administration are prohibited.
(2) Risk of concomitant medications: Inform the doctor of all concurrent medications before use to avoid contraindicated combinations (such as other MAO inhibitors, opioids, certain antidepressants, etc.).
(3) Monitoring adverse reactions: Blood pressure, dyskinesia, mental status, etc., should be monitored during treatment, with regular follow-up visits.
(4) Do not discontinue abruptly: If discontinuation is needed, the dosage should be gradually reduced under medical supervision.
