News
On November 26, 2020, the SAMR announced the temporary measures for on-site inspection on special food products in China.
Five health food ingredients to be filed according to the directory and technical requirements for raw materials from March 1, 2021 onwards.
The NMPA announced various updates regarding soap, toothpaste, hair removal, hair growth, breast beauty, body slimming and deodorizing products.
The NIFDC released 7 technical draft proposals for detecting chemical agents and the evaluation of efficacy claims in cosmetic products in China.
Ultrasonic coupling agents are reminded to comply with mandatory standards and any necessary filing changes must be completed by the end of February 2021.
The new draft clarifies the registration requirements and categorization method of different drug-device combination products in China.
3 GB standards announced; 14 technical guidelines and 2 draft guidelines were issued; 6 medical devices pending for fast-track approval
Due to the 2020 performance of the fast-track approval process for medical device registration in China, the CDME plans to implement a smart review process.
The China SAMR published the new ordinance TSG 23 covering previous regulations such as TSG R1003-2006, TSG R4001-2006, TSG R7002-2009, and TSG R7003-2011.
The MTC bundles the potential and expertise of our partners, increasing the innovative strength and international competitiveness of each individual company
The SAMR issued the 2020 directory of health food raw materials and nutrient supplements, expanding the number of approved health claims.
The NMPA issued guidelines to address the standard procedure of submitting risk evaluation reports after the occurrence of adverse events.
The CMDE shared a timeline of events for establishing regulatory control on AI medical devices and shared the latest status of their upcoming plans.
The State Administration for Market Regulation addressed the innovative development plan actions for drugs and medical devices in the Greater Bay Area.
China’s NMPA issues technical guidelines (trial) for utilizing real-world data (RWD) in the medical device clinical evaluation process.
Following the launch of the China’s national UDI system, the Hainan MPA has announced a pilot plan for the UDI system in Hainan with a larger product scope.
The new ordinance TSG 11 (Revision 2020) for safety technology for boilers was published with Notice 45/2020 of the authority SAMR.
The SAMR issued technical guidelines concerning toxicology, strains used, physicochemical properties and hygienic indicators for health food products
Since the implementation of the CSAR (Cosmetics Supervision and Administration) was officially announced in June 2020, China has been preparing for the regulation to become effective on January 1, 2021. In November 2020, the NMPA (National Medical Products Administration) released 5 regulatory updates to support the CSAR. We have summarised these below.
Draft instructions for cosmetic registration and filing dossiers
In order to implement the CSAR, this draft includes a total of 6 chapters and 57 articles to further clarify and refine the specific information requirements for cosmetics registration and filing.
The CSAR requires the manufacturers to register their special cosmetic products with hair coloring, hair perming, freckle whitening, sunscreen, anti-hair loss functions or with new efficacy claims, whilst filing would be required for general cosmetics (in the past referred to as non-special cosmetics).
The public consultation period is open until November 30, 2020.
Draft instructions for new cosmetic ingredient registration and filing
This draft includes a total of 28 articles addressing the requirements for the registration and filing for new cosmetic ingredients:
- Registrants are responsible for the safety monitoring of the new cosmetic ingredients and required to submit an annual report for three years
- Registration will be required for new cosmetic ingredients with higher risk functions such as antiseptics, sun protection, hair coloring, freckle removal, whitening, etc., while filing will be required for other cosmetic ingredients
The public consultation period is open until November 30, 2020.
Draft guidelines for cosmetic efficacy claim evaluation
This draft consists a total of 22 articles to provide technical guidance on the evaluation of efficacy claims for the cosmetics industry. Different types of efficacy claims require their own evaluation method and are identified in the draft to ensure their scientific character and accuracy.
The public consultation period is open until November 30, 2020.
Draft measures for the management of cosmetic supplementary testing methods
This draft consists of 6 chapters and 29 articles covering the scope, procedures, guidelines and rules of cosmetic supplementary testing methods. Such supplementary testing methods will be applied for sampling inspections, quality and safety investigations and adverse reaction investigation.
The public consultation period is open until December 10, 2020.
Draft administrative measures on toothpaste products
This draft consists of 23 articles addressing the requirements of ingredients, product filing and efficacy evaluation of toothpaste products:
- If the toothpaste product uses a new ingredient for the first time in the market, the registrant must ensure that a mandatory technical standard is implemented before marketing. If there is a standard already, only the safety evaluation report of the ingredient would be required for submission
- The NMPA will formulate the classification catalogue for efficacy claims and keep it updated in a timely manner
- There should be sufficient and reliable scientific evidence to support the efficacy claims
- The product labelling should not claim to have medical effects in an expressive or implicit manner
- Any violations including, but not limited to, the following will be punished:
- Not registering or filing the product as required
- Illegal use of other ingredients
- Violation of labelling requirements
- Not verifying the efficacy claims as required
The public consultation period is open until December 12, 2020.
If you are interested in making a public submission, please share your opinions with us before the consultation period ends.
By Jacky Li. Contact Cisema if you would like to learn more.
The draft guidelines cover real-time fluorescent PCR analyzers, disposable non-absorbent closure clamps, nanomaterials, and intravascular catheters
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