Regulatory News from Across Asia-Pacific

On 20.08.2019, the SAMR (State Administration for Market Regulation) announced that the health food regulatory framework will significantly change (No. 13-2019). Companies and individuals will be able to propose to the SAMR to add ingredients to the directory of health food raw materials and to increase the list of approved functional claims. These measures will take effect on 01.10.2019. The procedure under the old regulatory framework led to stagnation and did not produce major changes to the list of approved functional claims or health food raw materials.As reported before, on 28.03.2019, the SAMR had requested public feedback on three major adjustments to health food function claims. The proposed modification of 18, cancellation of 21 and analysis of 6 health function claims.

On 01.08.2019, the NMPA released a notice changing the consultation service of the “National Institute for Food and Drug Control” regarding cosmetics approval applications (No. 245-2019).1) Questions regarding the technical review of cosmetics, on-site consultation is available every Tuesday afternoon.2) Questions regarding the administrative/format review of cosmetics, telephone consultation is available all day on Tuesdays and Thursdays.

On 01.08.2019, the CMDE (Center for Medical Device Evaluation), published a revised “Clinical Trial Exemption List for Medical Devices”. 101 Class II and 41 Class III medical devices were added. The new clinical trial exemption list contains a total of 996 medical devices now. With regards to IVDs, 420 of class II and III IVDs are exempted.

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.