China NMPA Answers Questions about CSAR Implementation

On Jan. 14, 2021, China National Medical Products Administration (NMPA) held a news briefing on Cosmetic Supervision and Administration Regulation (CSAR) implementation. ^[1] During the briefing, the following three officials answered several questions about CSAR implementation.

Liubin Qi, Deputy Director of the Department of Cosmetics Regulation of NMPA;
Qingbin Lin, Researcher of the Division of Supervision I; and
Yunfeng Li, Division Chief of the Division of Supervision II.

Source: NMPA Official Website

ChemLinked summarizes the key points as follows.

1. No Pre-market Technical Review on Notification Documents

Notification is deemed as completed after the notifier submits the required notification documents through the Notification Information Management System. There is no pre-market technical review on notification documents. The products can enter the market after completing the notification.

MPAs will organize post-notification supervision and inspection of the notification documents and take corresponding measures such as ordering corrections within a time limit, suspension of sales, and notification cancellation if problems are found. Any violations of laws and regulations such as submission of false notification documents will be investigated and punished.

*The Cosmetics Notification Information Management System and the Administrative License Management System are being upgraded.

2. Efficacy Claims to be Managed through Social Supervision

The final version of Administrative Measures on Cosmetic Registration and Notification did not specify the requirements for submitting efficacy evaluation documents. Some industry media misunderstood this as the government's relaxation of efficacy evaluation requirements.

In fact, it has been clearly stipulated in the overarching regulation CSAR that scientific basis for efficacy claims shall be published on the special website designated by NMPA. During the Briefing, Deputy Director Qi emphasized, "This provision is to clarify that efficacy claims are to be managed through social supervision, rather than pre-market registration or notification."

The earlier Drafting Instruction of Guidelines for Cosmetic Efficacy Claim Evaluation also mentioned that the government would not ensure efficacy claims’ authenticity through administrative approval.

Transitional Period is Necessary for the Industry

According to JuMeiLi, challenges facing efficacy evaluation include:

The efficacy evaluation capabilities of small and medium-sized enterprises are relatively weak;
Domestic R&D talents for efficacy evaluation are in short supply;
There are only nine qualified testing institutions in China that can perform human trials. The undertaking capacity of testing institutions cannot meet the enterprises' needs;
Lack of efficacy evaluation standards. ^[2]

Supporting regulations for efficacy claims are being developed and will further clarify the management requirements. It is hoped that NMPA can give the industry a transitional period to adapt and improve evaluation capabilities.

3. Cosmetic Online Sales to be a Regulatory Focus

NMPA will formulate an independent Chapter in Supervision and Administration Measures on Cosmetics Manufacture and Operation to specify cosmetics online sales requirements. The special actions will continue to be carried out to clean up illegal products (such as products claiming "EGF, stem cells, medicated cosmetics, medical skin care products") sold online.

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