CSAR Subsidiary Regulations: China NMPA Consults on the Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices

It is the first time NMPA proposed conducting a separate inspection for the registrants and notifiers who entrust production enterprises to produce cosmetics, which will be a challenge for entrusting enterprises; If one core inspection item is not compliant, the enterprise’s production license will be revoked or the enterprise will be punished. The supervision for non-compliance behaviors will be more stringent.

On January 7, 2022, China NMPA issued the finalized Good Manufacturing Practices for Cosmetics and will implement it on July 1, 2022. Cosmetics registrants, notifiers, and entrusted production enterprises shall organize the cosmetic production in accordance with the Practices. Following that, on March 30, 2022, NMPA released the draft of Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices (hereinafter referred to as “Points”) for public consultation. ¹ Regulatory authorities across China will use the Points as a basis to determine whether the enterprise complies with GMP. Any suggestions about the Points can be mailed to NMPA (hzpjgc@nmpa.gov.cn) before April 20, 2022.

The Points is an upgraded version of Practice for Cosmetics Production Licensing implemented in 2016, with more stringent inspection requirements. The expected effective date of the Points is July 1, 2022, which is the same as that of Good Manufacturing Practices for Cosmetics.

Main Contents

There are a total of 106 articles in the Points, and separate inspection points are set for the manufacturing and entrusting enterprises.

1. Applicable Scope

2. Inspection Classification and Judgment Principles

3. Other Matters

Annex I Inspection Points for Cosmetic Good Manufacturing Practices (For Manufacturing Enterprises)

Annex II Inspection Points for Cosmetic Good Manufacturing Practices (For Entrusting Enterprises)

Applicable Scope

The applicable scope of the Points is divided into the following three categories,

For cosmetic registrants, notifiers, and entrusted production enterprises engaged in production activities (hereinafter referred to as “manufacturing enterprises”): regulatory authorities will conduct on-site inspections in accordance with Annex I. There are 82 inspection items in total, including 5 core items, 24 key items, and 53 general items.
For cosmetics registrants and notifiers who entrust production enterprises to produce cosmetics (hereinafter referred to as “entrusting enterprises”): regulatory authorities will conduct on-site inspections in accordance with Annex II. There are 24 inspection items in total, including 2 core items, 7 key items, and 15 general items.
For cosmetic registrants and notifiers who are engaged in both self-production activities and entrusted production activities: regulatory authorities will conduct on-site inspections in accordance with Annex I and Annex II.

This is also the first time NMPA has proposed conducting a separate inspection for the entrusting enterprises, which will be a challenge for them.

Judgment Principles

The following are the principles for judging whether an enterprise complies with GMP. The judgment principles are based on the severity and proportion of non-compliant items, a scientific supervision method.

It is worth noting that if one core item is not compliant, the enterprise's production license will be revoked, or the enterprise will be punished. The supervision for non-compliance behaviors will be more stringent.