Number of Adverse Reaction Tests Soars as China’s Cosmetic Regulation Tightens Again

Recently, Medical Products Administration in Hubei, Chongqing and other places released their annual reports on cosmetic adverse reaction monitoring in 2021, with the number of reports increasing by up to 70% year-on-year and the sources of reports gradually diversifying. It is clear that the monitoring of adverse reactions has become an important part of cosmetic regulation in China, and the attitude of cosmetic companies of “sitting it out” about adverse reactions is going to become a thing of the past. 

According to the Annual Report on Cosmetic Adverse Reaction Monitoring (2021) recently released by the China Hubei Provincial Medical Products Administration, the province a total of 8,039 Cosmetic Adverse Reaction/Event Report Forms were received in FY 2021 in Hubei Province, an increase of 70% compared to FY 2020, of which 8,036 were general reports and 3 were serious reports. Since 2016, the number of reports has always been on an incremental trend, with a 19-time increase in six years.

Meanwhile, the Annual Report on the Monitoring of Adverse Cosmetic Reactions in Chongqing in 2021, released by the Chongqing Municipal Medical Products Administration of China, showed that 5,050 reports were received during the period, an increase of 10.41% year-on-year, including 2 serious reports with an average of 158 reports per million population. In addition, the report also reminded consumers of the need for caution when purchasing cosmetics online, the high risk of cosmetic acne caused by sunscreen products and the ease of confusion between some children’s cosmetics and disinfection products.

Adverse reactions to cosmetics refer to the normal use of cosmetics caused by the lesions of the skin and its appendages, as well as local or systemic damage to the human body. Adverse reactions to cosmetics are reported by medical institutions, business units, manufacturing companies and individuals. In February this year, China’s National Medical Products Administration issued Measures for the Monitoring of Adverse Cosmetic Reactions (hereinafter referred to as the Measures), which will be implemented in October this year.

In the actual monitoring, the Measures clearly state that cosmetic adverse reaction reports follow the principle of “any suspicion should be reported”, and that any suspected human damage related to the use of cosmetics should be reported.

It is worth noting that the Measures also mention that other units and individuals can report adverse cosmetic reactions to the cosmetic registrant, the filer, and the person responsible for the territory, but also to the Chinese local city and county monitoring agencies or city and county-level regulatory departments.

In other words, according to the Measures, consumers can also report the phenomenon of adverse reactions directly to monitoring agencies and regulatory authorities at all levels in China, and companies must report or analyze and evaluate the adverse reactions within a specified period of time according to the extent of the adverse reactions

The number of adverse reaction reports has increased significantly in recent years and has become an important basis for supervision and inspection by the Chinese regulatory authorities, so it is clear that cosmetic companies cannot continue to “sit it out” but must take responsibility for establishing a cosmetic adverse reaction monitoring and evaluation system.

And, with less than five months to go before the official implementation of the Measures issued by the National Medical Products Administration of China. When the new adverse reaction monitoring system comes to be effective, it means that companies need to increase their monitoring efforts in terms of adverse reactions including arranging for commissioners to collect and register information on adverse reactions, setting up adverse reactions monitoring teams and reporting them in a timely manner. Otherwise, they will be punished in accordance with the Regulation on the Supervision and Administration of Cosmetics.

It is worth mentioning that on May 11, China’s National Medical Products Administration released the 14th Five-Year Plan on Drug Regulatory Network Security and Information Technology Construction also mentioned that it should continue to improve adverse reaction monitoring and other business systems in strengthening cosmetics regulatory capacity.

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