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NMPA publishes final cosmetic adverse reaction measures


Cosmetics China-REACH Regulatory update

On  February 15, 2022, the National Medical Products Administration of China (NMPA) published final measures for cosmetic companies to establish systems for monitoring adverse reactions of cosmetics. It is expected to come into force on October 1, 2022. This measure will apply to all companies who register/notify their cosmetic or cosmetic ingredients under Cosmetics Supervision and Administration Regulation (CSAR).

This measure consists of seven chapters that extensively lay down rules relating to the responsibilities and obligations for notifiers, cosmetics’ adverse reaction report requirements, adverse reaction analysis and evaluation, investigation on adverse reaction, and administration supervision methods.

According to the measure, adverse reaction means a normal and proper use of cosmetics resulting in pathology change in skin and other related health issues. For better monitoring of the adverse reaction, companies are required to establish post-registration adverse reaction monitoring systems. Such systems will be used to collect information on adverse reactions to cosmetics sold via various channels including distributors, shops, and hospitals. Domestic companies are required to report all this collected information to NMPA, while overseas companies comply with this via their Chinese responsible person such as their Only Representative  (OR) and importer. Though the information will be submitted to NMPA, all the collected information must be kept for at least three years.

Further, this regulation categorizes the reactions into three types according to their severity level:

  1.  Normal adverse reactions, which means minor ailments such as itchiness and rashes.
  2. Severe adverse reactions. It refers to large-scale or deep damage to the skin and organs, including mucous membranes and systemic damage to other organs.
  3. Extremely severe adverse reactions. It means those that might impact a lot of people or have a large social impact.

Based on different categories, the notification timeline is different. Normal adverse reactions must be reported to NMPA within 30 days when the adverse reaction is found, while reporting time for severe and extremely severe situations are shortened to 14 days and 3 days respectively.

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