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{"id":8869,"date":"2021-08-16T11:52:11","date_gmt":"2021-08-16T09:52:11","guid":{"rendered":"https:\/\/www.chameleon-pharma.com\/china-regulatory-affairs\/"},"modified":"2022-03-28T11:24:41","modified_gmt":"2022-03-28T09:24:41","slug":"china-regulatory-affairs","status":"publish","type":"page","link":"https:\/\/www.chameleon-pharma.com\/es\/services\/pharma-regulatory-registration\/china-regulatory-affairs\/","title":{"rendered":"China – Regulatory Affairs"},"content":{"rendered":"

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China – Regulatory Affairs<\/span><\/h1>\n

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China has estab\u00adlished an impres\u00adsive Health\u00adcare indus\u00adtry struc\u00adture, becom\u00ading one of the largest OTC and Pharma pro\u00adduc\u00aders in the world. <\/strong>However, the regulatory process can be confusing for foreigners trying to enter this lucrative and rapidly growing market.<\/p>\n

[\/et_pb_cta][et_pb_cta title=\u00bbRegulatory Body – NMPA\u00bb _builder_version=\u00bb4.15.1″ _module_preset=\u00bbdefault\u00bb header_text_color=\u00bb#000000″ body_text_color=\u00bb#000000″ background_color=\u00bb#bbccee\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n

The regulatory body in China responsible for the registrations is called the National Medical Products Administration<\/a> (NMPA).<\/p>\n

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Pharma Prescription Drugs<\/h2>\n

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<\/strong> within the territory of the People\u2019s Republic of China. All prescription pharma products must receive approval from the NMPA<\/strong> and there are different requirements and pathways<\/strong> depending on several criteria such as the existence of a national drug standard, or the indicated claims.<\/strong><\/p>\n

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Consumer Healthcare Drugs\/OTC<\/h2>\n

In China, OTC drugs are divided into Class A and Class B,<\/strong> and marketing can only be done following approval by the NMPA.<\/strong> Additionally, all imported consumer health products must obtain an Imported Drug License from the NMPA.<\/strong><\/p>\n

With our long-term experience and network with the NMPA, we can offer a relatively fast registration<\/strong> process for Consumer Healthcare & OTC drugs in China.<\/p>\n

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Medical Devices<\/h2>\n

In China, Medical devices are controlled based on a classification system. There are three classes of Medical Devices (I, II, and III)<\/strong> 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.<\/strong><\/p>\n

In addition to having different classes,<\/strong> 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<\/strong> for the country where the manufacturing is carried out.<\/p>\n

 <\/p>\n

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Food Supplements\/Nutraceuticals<\/h2>\n

Food supplements and nutraceuticals in China are labelled as \u201chealth foods\u201d<\/strong> and are defined as food products<\/strong> that have specific health functions or supply vitamins or minerals<\/strong> but are not used for the purpose of curing disease. Health foods must be registered with the NMPA<\/strong> and obtain either a health food registration certificate<\/strong> or filing certificate. Overseas companies attempting to register health foods for sale in China<\/strong> must have a permanent Chinese representative office or local agent.<\/p>\n

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Cosmetics and Derma<\/h2>\n

Cosmetic products are defined as \u201cProducts 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\u201d. In China, cosmetics are further divided into special use cosmetics (SUC)<\/strong> and non-special use cosmetics (non-SUC).<\/strong> 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.<\/strong><\/p>\n

Cosmetics marketed in China must get approval from the NMPA<\/strong>. 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.<\/p>\n

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Photo by Hanson Lu<\/a> on Unsplash<\/a><\/p>\n

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Frequently Asked Questions from Clients – Regulatory Affairs<\/h2>\n

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