China Consults on Draft Regulations for Cosmetic Overseas Inspection

China is proposing to strengthen post-market surveillance on imported cosmetics, which would require foreign manufacturers to undergo overseas inspection of product manufacturing/processing facilities. The draft regulation includes details on overseas cosmetic inspection procedures, including inspection scope, the competent authority, results, and penalties for violation of the regulation.

On November 22, China National Medical Products Administrative (NMPA) publicized a draft version of Interim Regulations for Cosmetics Overseas Inspection (The English translation will be uploaded soon). The Regulations are open to public comments. Stakeholders with any suggestions or opinions can send back to NMPA via email at [email protected] before December 22, 2019. Notably, the email subject shall indicate “化妆品境外检查暂行管理规定," which is the corresponding Chinese name of the draft Regulations.

(Content of the Provisions)

The draft regulations encompass five chapters, thirty-six articles, and six supporting documents. The primary goal of the government is to enhance the post-market supervision on imported cosmetics and align the inspection requirements for both foreign and domestic companies.

Cosmetic overseas inspection

It refers to the overseas onsite inspection conducted by NMPA to confirm the authenticity, reliability, and compliance of overseas R&D and manufacturing process of cosmetics as well as application dossiers.

Inspection scope

According to the draft Regulations, the cosmetics that have been imported or will be imported in China will be subject to overseas inspection of NMPA.

Inspection authorities

NMPA will be responsible for the management of overseas inspection. The Center for Food and Drugs Inspection of NMPA will be accountable for the organization and implementation of offshore inspection.

Inspection plan

Inspection protocols will be stratified based on risk assessment and random checks. Inspection priority will be given in the following circumstances:

Manufacturers with history of safety problems related to product registration/filing, inspection, adverse reaction monitoring, complaints, tip-offs, etc.
Larger enterprise with significant annual sales volumes

Inspection results and penalties

1) Compliant: no defect or a slight defect is found during the onsite inspection
2) Compliant after rectification: All serious and general defects found during the inspection can be corrected
3) Non-compliant.

Penalties for violations include corrective actions, warning letters, suspension of import and sales, product recall, investigation, etc.