On January 12,2021 China’s Health Authority, the NMPA released The Regulation “Measures of Cosmetics Registration and Filing Management” and will come into effect May 1, 2021. Of particular importance is Chapter II of the regulation, which provides the details regarding the filing process for raw cosmetic ingredients with Chinese NMPA.
New Raw Cosmetic Materials Filling Agencies and Timelines:
About the Technical Agency Review:
1) Complete applications with controllability of safety and quality of the raw material, meets legal requirements, country standards and technological needs are approved
2) Unrealistic applications which do not show controllability of safety and quality of the raw material, that do not meet legal requirements, country standards and technological needs are not approved
3) Applications lacking information will be given a one-time feedback and given a chance to submit a complete application within 90 days; if no additional application is submitted, the evaluation will be treated as not approved
- Set up a pharmacovigilance monitoring/evaluation system to trace safety of the new cosmetic raw material, to monitor and review the new raw material of the cosmetic
- Provide annual report within 30 days prior to the end of the year each year during safety monitoring
- Cosmetic companies that have determined a safety issue with the cosmetic raw material used in the production of the cosmetic must inform the raw material applicant.
- Adverse events have to be immediately controlled and one should inform the local drug regulatory department (whether provincial, in the self-autonomous region or in a municipality directly under the Central Government (Shanghai, Beijing, Tianjin, Chongqing). The provincial departments will also do a more thorough research on the event.
Situations to Report to the Technical Review Agency:
Cosmetics manufacturers/raw material manufacturer have to report the Technical Review Agency if:
- Other countries have found adverse events associated with the use of the cosmetic/group adverse event,
- Other countries have increased the amount of regulation/law/standard for the raw material or forbid its use,
- Or if there are any other relevant situations to the new cosmetic raw material.
Technical Review Agency Role in monitoring:
- After receipt of agency safety report report from either provincial, self-autonomous and under a municipality directly under the Central Government, may file to NMPA if they believe the material requires adjustments to safety.
- Additionally, if the safety issue is of concern, the Technical Review Agency will report to NMPA for it to make a decision on cancelling registration/filing.
- After 3 years of safety monitoring, the Technical Review Agency will ask the NMPA if the cosmetic raw material still fits safety requirements
- During the monitoring period, the new raw cosmetic material can still be used for production of cosmetics.
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices , pharmaceutical, cosmetic and food supplement companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.