3 Cosmetics Draft Regulations Issued for Public Consultation

In July 2020, the NMPA (National Medical Products Administration) announced three drafts and launched a public consultation to solicit comments:

Draft of the administrative measures for cosmetics registration and filing in China

• The draft was announced on July 21, 2020.
• The public consultation ends on August 20, 2020.
• What’s New?
  • The requirements of the registrants and filers have been specified:
    • Well-established QMS (Quality Management System)
    • The person in charge of quality and safety should possess more than 5 years of professional experience in quality management or manufacturing of cosmetics
    • Well-established management system for supplier selection, checking of raw materials upon arrival, manufacturing process, quality control, facility equipment, product inspection, etc.
    • Well-established safety risk assessment, adverse events monitoring, and recall policy for cosmetics
  • The filers should submit the annual report of the products manufactured and imported, as well as the adverse events monitoring report every year to their respective MPA (Medical Products Administration) in China. 
  • During the technical review process, if any false information has been identified in the application submitted, a local or overseas on-site inspection may be required, but subjected to the actual circumstances.

Draft of the classification rules and catalogue

• The draft was announced on July 29, 2020.
• The public consultation ends on August 30, 2020.
• The classification catalogue was drafted in detail according to:
  • Efficacy claims
  • Body parts
  • Product forms
  • Age groups
  • Usage

Draft of the technical guidelines for the safety assessment on cosmetics

• The draft was announced on July 29, 2020.
• The public consultation ends on August 30, 2020.
• Highlights of the draft for the safety assessment procedures of cosmetics include, but not limited to the following:
  • Scope of application
  • Basic Principles and requirements
  • Requirements of the safety assessment inspector
  • Risk evaluation procedures
  • Toxicology of cosmetics
  • Risk evaluation of raw materials
  • Post-market surveillance
  • Safety assessment report

By Jacky Li. Contact Cisema if you would like to learn more.