Takehome: Administration approval of cosmetic manufacturing license and imported cosmetics filing management have been optimized in Shanghai. The system which was previously subject to the geographical restriction within a part of Shanghai has now been expanded to all of Shanghai.
In line with the State Council’s Notice to advance the Reform of “Separating Certificates from Business License” nationwide, Shanghai FDA announced on Nov. 16 a new pilot initiative designed to promote the reform of simplifying cosmetic administration approval. The program which was in the past restricted to a specific area of Shanghai is now expanded to all of Shanghai. The new system introduces the following 5 improvements:
- Adopt electronic certificates and carry out the full-process online business processing system.
- Shorten approval duration. The specific processing time of cosmetic business at present is as follows:
| Name of items | Name of sub-items | Original duration for approval | Current duration for approval |
| Cosmetic Manufacture License | Apply for new license | 60 | 40 |
| 1) Alteration of the registration items in the license; 2) Change of the responsible person of the enterprise or of quality; 3) Reissuance. |
60 | Approve on the spot | |
| Change (excluding 2)) and renewal of the license (if on-site inspection is required) | 60 | 40 | |
| Change (excluding 2)) and renewal of the license (if on-site inspection is not required) | 60 | 10 | |
| Cancellation of the license | 60 | 10 | |
| Filing of first-imported non-special use cosmetics | Apply for filing | 30 | Approve on the spot |
- Disclose approval procedures, processing progress and business guidance including handling basis, accepting conditions, required materials and durations for applicants to refer to.
- Establish an inter-sectoral coordination mechanism to advance information sharing and strengthen in-market and post-market surveillance. Quality supervision and random inspection will be rolled out and use risk-based management which assigns differentiated priority to different categories of cosmetics based on their inherent characteristics. Key categories such as special use cosmetics will be subject to stringent requirements.
- For affairs relating to cosmetic manufacture license, simplification of approval dossiers and online access to the production license, legal representative’s identification, etc. will also be realized.
The existing effective normative documents regarding cosmetic supervision in Shanghai are listed below:
| No. | Document Name | Release Date | Implementation Date |
| 1 | Shanghai FDA’s Rules on Procedure of Administrative Penalty | 2013.12.24 | 2014.01.01 |
| 2 | Administrative Measures for hygiene license of Cosmetic Manufacturers in Shanghai | 2015.08.05 | 2015.08.05 |
| 3 | Notice on Issuance of ‘Shanghai FDA’s Rules for the Application of Administrative Penalty Discretion’ and ‘Guidelines on Administrative Penalty Discretion’ | 2016.01.12 | 2016.02.01 |
| 4 | Administrative Measures for the Key Supervision Lists of Serious illegal Food and Drug Manufacturers or Traders and others responsible in Shanghai | 2016.07.04 | 2016.08.15 |
| 5 | Reward Measures on Reporting the Malfeasance of Drugs, Medical Devices and Cosmetics in Shanghai | 2017.01.05 | 2017.02.15 |
| 6 | Shanghai FDA’s Administrative Measures for the Disclosure of Supervisory Information | 2018.01.08 |
2018.02.08 |
| 7 | Regulations of the Management on Credit Information of Food and Drug Manufacturers or Traders in Shanghai | 2018.01.25 | 2023.02.28 |
We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
