Chapter 1 China NMPA regulatory information introduction

1. Eaa and Introduction

NMPA(National Medical Products  Administration is the competent department of cosmetics in China, the full name is the State Drug Administration, which is specifically responsible for the registration, management, supervision, inspection, foreign exchange and cooperation of cosmetics.

2. Supervision and regulation

《Regulations on the Supervision and Administration of Cosmetics -2020 edition》

《Cosmetics registration and filing management method -2021 edition》

3. Definition and classification of Chinese cosmetics

According to the Regulations on the Supervision and Administration of Cosmetics, cosmetics refer to daily chemical industrial products that are applied to skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying.

In China, makeup is divided into special cosmetics and ordinary cosmetics, and toothpaste has a separate management method. Special cosmetics need to be registered in NMPA, and other categories are subject to record management.

4. Entry requirement

The registration/record holder of imported cosmetics shall meet the following conditions:

①Enterprises or other organizations established by the Law;　　

②There is a quality management system suitable for applying for registration and filing cosmetics, and the type of production specification certificate can be issued by the competent government department of the country (region) where it is located, or issued or recognized by a certification body or a third party;　

③Ability to monitor and evaluate adverse reactions.

Cosmetic registration requires raw material safety information, you can directly link the raw material safety information file through the raw material submission code, or fill in the raw material manufacturer's information and upload the raw material safety information file issued by the raw material manufacturer (this requires the raw material manufacturer's authorization).

Import products need to submit a letter of authorization from the domestic responsible person and a notarial certificate of authorization from the domestic responsible person.

5. Registration language 

Simplified Chinese

6. Domestic responsible person

For an overseas registrant or record holder, an enterprise legal person in China shall be designated as the domestic responsible person. The domestic responsible person shall perform the following obligations:

①Handle cosmetics registration and filing in the name of registrant/recordholder;

②Assist registrants/recordholders in monitoring and reporting cosmetic adverse reactions; Assist registrants/registrants to implement cosmetic recall;

③In accordance with the agreement with the registrant/record holder, undertake the corresponding quality and safety responsibility for the cosmetics put on the domestic market;

④Cooperate with the supervision and inspection work of the drug regulatory department.

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

2. Registration period and official fees

Before the general cosmetics and toothpaste are listed or imported, the filing party shall submit the filing data through the information service platform in accordance with the requirements of NMPA.

The registration of special cosmetics will involve the review of technical review institutions, and there is only one opportunity to make up, and the official review cycle is 4-10 months.

NMPA does not charge a fee for either registration or filing.

Chapter 3 FAQ 

Q：What is the validity period of China Cosmetics Registration Certificate?

A：Five years.

Q：Can the domestic responsible person be replaced for the cosmetic products that have been filed/registered?

A：Agreed. Where the domestic responsible person is changed, the following information shall be submitted:

①To change the product list of the domestic responsible person;

②The informed consent form sealed by the original responsible person within the territory agreeing to change the responsible person within the territory, or the judgment document that can prove that the change of the responsible person within the territory has taken effect;

③Letter of commitment for the domestic responsible person to undertake the relevant responsibilities of the original domestic responsible person for the product (including the product that has been listed before the change).

After the change of registered special cosmetics is completed, the original product registration certificate shall be returned when receiving the paper product registration certificate after the change.