On February 21, 2022, the NMPA (National Medical Products Administration) issued (No.16-2022) the finalized regulatory measure for monitoring the adverse reactions of cosmetics in China. The measure was written in accordance to the new Cosmetics Administration and Supervision Regulations (CSAR), and will come into effect on October 1, 2022.
Highlights
- The regulatory document consists of 7 chapters and 47 articles covering general provisions, duties and obligations for adverse reaction reporting, adverse reaction analysis and evaluation, adverse reaction investigation, etc.
- Overseas registrants and filers should establish a system with their domestic responsible person for collecting and carrying out evaluation, reports and investigations on adverse reactions.
- Adverse reactions are classified into three levels: General, Serious, and Great Impact to the Community. There are corresponding regulatory measures to be carried out for each different levels of classification.
- Adverse reaction monitoring plays an important role in post-market risk warning, and this regulatory measure aims to enhance the level of risk prevention and control effectively.
By Jeff Jiang. Contact Cisema if you would like to learn more.
