News

On 10 July 2019, the Italian association for cosmetics industry (Cosmetica Italia) hosted a seminar on the regulatory environment of cosmetics in China. The seminar was held in collaboration with Cisema, which is specialised in the registration and certification of cosmetics in China.Following the seminar, Miriam Bandinelli, a Cisema business consultant, shared her knowledge in 2B2 interviews with individual member companies. The response was very positive: 50 Italian companies attended the event in person and via webinar. This shows the great interest of Italian companies in China, one of the main markets of the cosmetics industry.

On 01.07.2019, the 2018 Drug Review Annual Report was released. Of the grand sum of 9,796 registration applications reviewed and approved in 2018, 7,988 were subject to technical review and 1,808 to direct administrative approval.

On 25.06.2019, the NMPA announced the requirements for overseas new drugs, which are urgently needed. The guidelines serve to speed up the drug approval.

On 03.07.2019, the NMPA initiated the Pilot Work Plan for the “Unique Device Identification” (UDI) (No.56-2019), as announced in February 2018. The UDI mark, is made up of a combination of numbers and barcodes. It carries information about the product (i.e. identifying the license holder, the model specification and packaging) and its production (i.e. production batch number, production date, expiration date). The NMPA will approach applicants, which have to provide UDI applying for approval. During the pilot phase, it will be for high-risk medical devices only (such as heart, craniocerebral implants and prostheses).

On 31.05.2019 and 06.06.2019, the NMPA (National Medical Products Administration) and CMDE (Center for Medical Devic Evaluation) released three announcements regarding the eRPS (NMPA No. 46-2019; CMDE No. 4-2019; CMDE No. 5-2019). The eRPSystem serves the electronic management of medical device registrations. Starting on 01.11.2019, all documents for class II and III registration, change and renewal applications shall be submitted through this system. No hard copy documents will be accepted – except for class I medical devices. In order to log into the eRPS, a CA (Certificate Authority) has to be applied for. Once a CA is received, the applicant is only allowed to use the eRPS for further applications.

On 12.07.2019, the NMPA released a draft for the examination requirements of medical device applications (No. 42-2019). The CMDE of the NMPA is now additionally involved in the approval process by reviewing the application dossier, judging its integrity, compliance and consistency in accordance with the latest requirements.

On 14.05.2019, the NMPA (National Medical Products Administration) updated technical review guidelines on the timeline of active medical devices (No. 23-2019). As part of the medical device registration, applicants have to verify their products’ lifespan. The lifespan describes the period in which the safe use of the product is ensured, the product can be used effectively, and residual risks are still within acceptable limits.

On 07.05.2019, the CMDE (Center for Medical Devic Evaluation), announced the introduction of NMPA’s new eRPS System (Electronic Regulated Product Submission System - https://erps.cmde.org.cn). The system is used for the electronic management of medical device registrations. In future, all documents for NMPA registrations shall be submitted to through this eRPS System. No hard copy documents will be necessary.Since 10.05.2019, it is possible to apply for a CA (Certificate Authority) certificate via the eRPS System. The CA certificate is necessary to be able to log into the electronic submission system. Every registration applicant of domestic medical devices class III has to apply for a CA certificate. Equally, every NMPA Legal Agent of an imported medical device has to apply for a CA certificate on behalf of the NMPA registration applicant, the foreign manufacturer.

On 14.02.2019, the MOFCOM suspended the filing and administrative approval of direct selling companies due to unreasonable promises with regards to health foods. In collaboration with the SAMR, MOFCOM is overhauling the health food market in China by optimizing the direct sales regulatory system.

On 28.03.2019, the MOA (Ministry of Agriculture), published a notice regarding two administrative licensing items, which were abolished on 27.02.2019. First, the clinical trial approval of new veterinary drugs was changed to filing system. After completion of the laboratory study of the veterinary drug, the clinical trial can be carried out, without waiting for the approval of the authority. Second, the MOFCOM (Ministry of Commerce) no longer issues import licenses for veterinary biological products. It is no longer necessary for the Chinese import agent to provide such a copy when applying for customs clearance.

On 28.03.2019, the SAMR (State Administration for Market Regulation) released three major adjustments to health food function claims, which are open to public comments. First, 18 health function claims are being modified because they are deemed imprecise, misleading or exaggerated. For instance, SAMR suggests to replace 减肥 (Fat reduction) with 有助于调节体脂 (Bodyfat Adjustment Support). Second, 21 existing health food function claims might be cancelled. Even though they were considered acceptable in the past, they will not gain approval when reviewed now. For example 促进头发生长 (Promotes hair growth). Third, 6 health care function claims will have to be further studied and proven, as they are easily confused with drug-like disease prevention or treatment. For example 辅助降血压 (Helps Lower Blood Pressure).

On 01.04.2019, the NMPA (National Medical Products Administration - former NMPA) announced a change in the clinical trial approval process for medical devices (NMPA No. 2019-26). If the applicant has not received any feedback within 60 working days from the date of clinical trial approval application, clinical trials can be carried out. Instead of an approval notification, the NMPA’s website will display the approval number, the applicant's name and address, as well as the name, the model specification, structure and composition of the medical device.

On 13.03.2019, the SAMR (State Administration for Market Regulation) released new review measures for advertisements for pharmaceuticals, medical devices, health foods, and food for special medical purpose. The draft is open to public comments.