China – Regulatory Affairs
China has established an impressive Healthcare industry structure, becoming one of the largest OTC and Pharma producers in the world. However, the regulatory process can be confusing for foreigners trying to enter this lucrative and rapidly growing market.
Regulatory Body - NMPA
The regulatory body in China responsible for the registrations is called the National Medical Products Administration (NMPA).
Pharma Prescription Drugs
Registration of prescription drugs in China can be quite tricky, but with such a lucrative market, it is definitely worth the trouble. One important distinction is that any overseas applicants seeking import drug registrations must have a subsidiary or partner company within the territory of the People’s Republic of China. All prescription pharma products must receive approval from the NMPA and there are different requirements and pathways depending on several criteria such as the existence of a national drug standard, or the indicated claims.
Consumer Healthcare Drugs/OTC
In China, OTC drugs are divided into Class A and Class B, and marketing can only be done following approval by the NMPA. Additionally, all imported consumer health products must obtain an Imported Drug License from the NMPA.
With our long-term experience and network with the NMPA, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in China.
In China, Medical devices are controlled based on a classification system. There are three classes of Medical Devices (I, II, and III) based on the degree of risk they present. The rules for device classifications are quite specific and can vary greatly depending on different criteria. Class I devices are subject to the least regulatory control and class III, the most.
In addition to having different classes, different regulatory pathways also exist for bringing your medical device to the market. Class I devices are subject to filing administration and Class II and III devices require a registration administration. All imported medical devices must already have distribution permissions for the country where the manufacturing is carried out.
Food supplements and nutraceuticals in China are labelled as “health foods” and are defined as food products that have specific health functions or supply vitamins or minerals but are not used for the purpose of curing disease. Health foods must be registered with the NMPA and obtain either a health food registration certificate or filing certificate. Overseas companies attempting to register health foods for sale in China must have a permanent Chinese representative office or local agent.
Cosmetics and Derma
Cosmetic products are defined as “Products which can be spread on the outer surface of the human body (e.g. skin, hairs, nails, lips etc.), the teeth and oral mucosa for the purpose of cleaning, protecting, beautifying, deodorizing and keeping in good condition, by way of smearing, spraying or other similar means”. In China, cosmetics are further divided into special use cosmetics (SUC) and non-special use cosmetics (non-SUC). Non-SUC products include skin care products, makeups and perfumes whereas SUC products include hair growth products, slimming products, sunscreens, etc. Interestingly, soaps, toothpaste, and oral cleansers are not considered as cosmetics in China.
Cosmetics marketed in China must get approval from the NMPA. Imported SUC products require pre-market registration and can only be imported after receiving approval, whereas non-SUC products require a pre-market filing and can be imported after the filing has been finished.
Frequently Asked Questions from Clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- Will my existing BE studies be accepted in China?
- What are the important things to take understand with regards to
trademarks by the NMPA?
- Can my home company act as a MAH in China?
- What is the difference in climate zone for stability studies in China vs. Europe and Latin America?
- Is the fast track registration process possible for my products in China and what to be aware of?
- What are the pharma/prescription drug registration costs and time in China?
- How many trademarks should be suggested to the NMPA and why?
- How can my own company be MAH in China for my products?
- What are the Consumer Healthcare Drugs/OTC registration costs and time in China?
- How to register Herbal, Phyto OTC, and traditional Chinese medicine drugs in China via fast track process and why to prepare the market entry strategy before?
- What do I need to know about climate zone for stability studies in China?
- Is a fast track registration process available in China and what to make sure of?
- What is the difference between Medical Device registration and definition in China vs. Europe, North America and throughout Latin America?
- Is my product considered a Medical Device by the laws of the NMPA?
- What are the important differences in trademark registration in China with regards to the NMPA for Medical Devices?
- Are local clinical trials necessary in China?
- Can my company act as a MAH in China?
- Climate zone for stability studies in China
- Is a fast track registration process available in China and what to be aware of?
- How difficult is the registration of Medical Devices in China?
- What are the Medical Devices registration costs and time in China?
- To which class of Medical Devices does my product belong?
- How to register claims on the pack for Food Supplements in China with the NMPA?
- Why trademark registration in China can be a very difficult task with the NMPA?
- Can my company act as a MAH in China for Food Supplements?
- What Climate zone for stability studies do I need for Food Supplements in China?
- How difficult is the registration of Food Supplements/Nutraceuticals in China?
- What are the Food Supplements/Nutraceuticals registration costs and time in China?
- How to register claims in China for Cosmetics with the NMPA?
- Why is the trademark registration for Cosmetics and Derma products a big topic in China?
- Can my company act as a MAH in China or do I need a local partner for registration?
- What are the important topics about climate zone for stability studies in China?
- How difficult is the registration of Cosmetics in China?
- What are the Cosmetics registration costs and time in China?