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China NHC to Terminate Emergent Market Entry of Disinfectants

On June 19, 2020, the General Office of the National Health Commission opened a 30-day consultation on a notice concerning the enhanced regulation of disinfection products during the Covid-19 control, aimed to resume the normal record-filing management of non-new disinfectants and ensure the safety and effectiveness of disinfection products produced in China, as well as intensify the ex-post surveillance of disinfection products already been placed on the market.

In February, NHC announced the interim measures for the emergency use of 4 disinfectants: Alcohols, chlorines, chlorine dioxide, and peroxyacetic acid disinfectants that satisfy simple technical requirements can be placed on the market instead of completing the full record-filing formality with the provincial health authorities, the compulsory requirements for the market entry of all non-new disinfectants in China.

NHC pointed out that the interim measures that time was in response to the partial shortage of disinfectants lead by the serious outbreak and factory stoppage. Given the fact the Covid-19 prevention has transformed from an emergent state to a normalized one and the liberal supply, the provincial authorities are suggested to take adjusted measures to local conditions:

  • The placing of disinfectants through the interim procedures shall be suspended as of the date of the final promulgation of the notice;

  • The domestic producers or Chinese representative legal entity of the emergently placed disinfectants shall complete the record-filing formality following the “Provisions for the Hygienic and Safety Evaluation of Disinfection Products”, otherwise their production and marketing activities shall be suspended after October 2020.

NHC urged domestic producers to strengthen their production management and quality control. The export-purpose disinfectants shall meet the quality requirements in both China and the export destinations.

Since the beginning of this year, China has released a dozen national standards concerning the efficacy evaluation, toxicity test, compulsory technical requirements and the ingredient lists of disinfectant/disinfectors, some of which will come into effect on October 1, 2020.
 

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