China Simplifies Safety Assessment Requirements for NCIs and Accelerates Product Launches Using NCIs

On February 6, 2025, China’s National Medical Products Administration (NMPA) released and implemented Several Provisions on Supporting Innovation of Cosmetic Ingredients. The key points can be summarized into: 1) Simplifying safety assessment requirements for NCIs; 2) Establishing a concurrent application mechanism for NCIs and related products; 3) Improving safety monitoring period management.

Background

Since the implementation of the Cosmetic Supervision and Administration Provisions (CSAR) in 2021, the China National Medical Product Administration (NMPA) has introduced a risk-based classification system for cosmetic products and NCIs. High-risk NCIs must undergo registration with the NMPA, while low-risk NCIs only need to be notified and can subsequently be manufactured and imported once enterprises complete the online dossier submission. This streamlined process reduces the market entry threshold for NCIs in China.

However, the cosmetics industry still faces several challenges and constraints in areas such as technical requirements for NCIs, guidance services, standard setting, and enhancing innovation capabilities.

On February 6, 2025, China’s National Medical Products Administration (NMPA) released and implemented Several Provisions on Supporting Innovation of Cosmetic Ingredients. ¹ The Provisions outlines nine specific measures from multiple dimensions, including classification management, review and approval, and standard setting, with the aim of systematically supporting innovation in cosmetic ingredients and promoting high-quality development in the industry.

To ensure effective implementation of the Provisions, the NMPA also released an official policy interpretation, detailing the drafting purpose, formulation principles, key points, and technical requirements. ²

The Provisions can be summarized into the following three key points:

1. Simplifying Safety Assessment Requirements for NCIs

Based on the characteristics, functions, and innovation levels of ingredients, the Provisions classifies NCIs into three categories: "NCI used for the first time at home and abroad," "NCIs with a substantial safety history," and "NCIs Innovated from existing ingredients," each with differentiated safety assessment requirements.