Note: This is part of a series of overviews of drug policies and regulations in countries outside the United States as they relate to Internet-based pharmaceutical sales. In LegitScript’s day-to-day operations evaluating the legitimacy of Internet pharmacies, our analysts monitor websites and advertisements in countries around the world — and our classification standards extend to these countries’ applicable laws and regulations.
When it comes to Internet pharmacy regulations, like most other things, Mainland China and Hong Kong currently operate under a “one country, two systems” philosophy. This means mainland China and Hong Kong have very different laws and government systems.
China Food and Drug Administration (formerly State Food and Drug Administration) is the authority organization of mainland China. All medicines and dietary supplements that are sold in China must be registered with CFDA, and websites that sell medicines must be registered with CFDA as well.
As for Hong Kong, the authority organization is the Drug Office of the Department of Health. All medicines that are sold in Hong Kong must be registered with Drug Office of the Department of Health. The registration number is required to be printed on the product packaging.
How are drugs classified in mainland China?
Drugs are classified as:
(1) Controlled substances:
- Controlled Narcotic Drugs (require special prescriptions by special licensed doctors)
- Controlled Psychotropic Drugs (require special prescriptions by special licensed doctors)
(2) RX/Prescription Only Medicine
(3) OTC Medicine:
- Category A OTC (red logo), can be sold in pharmacies or hospitals
- Category B OTC (green logo), can be sold in retails stores, pharmacies or hospitals.
(4) Cross-over medicine: Some medicines can be either OTC or prescription depending on whether the patient needs to take it short-term or long-term. Example: Aspirin is an OTC medicine, but doctors will prescribe it if the patient needs it for long-term use.
How are drugs classified in Hong Kong?
(1) Rx/Prescription Only Medicine:
- Western Rx Medicine
- Chinese Traditional Rx Medicine
(2) OTC Medicine:
- Non-poison, can be sold in retail stores.
- Category II Poison, can be sold in pharmacies.
- Category I Poison, can be sold in pharmacies under pharmacist supervision.
According to the Drug Office of the Department of Health, “the word ‘poison’ serves as a warning to consumers as using incorrect dosage or improper use of these medicines may cause serious health damage.” These medicines should be taken only on the advice or instruction of a healthcare professional. Details of non-poison drugs can be found here.
Are online pharmacies allowed in China?
For mainland China, only OTC medicines are allowed to be sold online.
For Hong Kong, only OTC (non-poison) medicines are allowed to be sold online.
What is permitted and prohibited for online pharmacies operated in China?
In mainland China, only over-the-counter (OTC) medicines can be sold online. It is OK for CFDA-registered online OTC pharmacies to display prescription drugs on their websites, but they cannot sell them via the Internet.
Registered OTC medicines and dietary supplements are required to have a corresponding logo on the product packaging (outlined below). The CFDA database provides a full list of registered medicines, dietary supplement and registered online OTC pharmacies.
In Hong Kong, pharmaceutical products are divided by Western medicines (registration number “HK-xxxxx”) and Chinese traditional medicines (registration number “HKC-xxxxx”).
- Western pharmaceutical product registration can be searched here.
- Chinese traditional medicine registration can be searched here.
- Registered pharmacy/drugstore registration can be searched here.
What are the pharmacy license requirements for online pharmacies?
For mainland China, all OTC pharmacies must register with CFDA and display their certification on their website. (See image below.) LegitScript has discovered that some of the rogue Internet pharmacies in China display fake CFDA certificates. If you are thinking about ordering drugs online and are in China, please be sure to check the Internet pharmacy’s domain name and the registration number on the certificate against the CFDA database to confirm the pharmacy’s legitimacy.
For Hong Kong China, a Listed Seller of Poisons (LSP) license is required to sell non-poison OTC medicines.
What are the China-specific rules that consumers should know about?
For mainland China, all dietary supplements and medicines being sold also must be registered with CFDA. Each product should have a registration number. Please check the CFDA database for the product legitimacy before purchasing.
For Hong Kong, all medicines being sold must register with Drug Office of the Department of Health. Each product should have a registration number. Please check Drug Office of the Department of Health database for the product legitimacy before purchasing.
What are some of the hallmarks of a Chinese rogue pharmacy website?
So far, LegitScript has identified a number of Chinese rogue Internet pharmacies, such as ok099.com and 0451nj.com. The majority of them focus on selling one product and accept payment upon delivery.
What are some other examples of problematic pharmaceutical products that are sold online in China?
Psychoactive high products are often seen on Chinese rogue pharmacy websites, along with descriptions on how to use these drugs for criminal purposes. One example is mmiyao8.com. This rogue Internet pharmacy sells Triazolam, which is a prescription-only medicine in mainland China. This website is also selling a large selection of products that claim to be Ecstasy drugs, such as Ecstasy liquid, and states, “Once it takes effect on the other person, he/she will be controlled and do whatever you say … .” LegitScript recommends that consumers stay away from these types of websites.