On August 26, 2019, the China’s National People’s Congress passed The Amended Drug Administration Law (the Amended DAL) which will go into effect on 01.12.2019. The revised law establishes strict standards and measures in supervision over the whole process of the pharmaceutical industry chain in order to address prominent problems within research and development, manufacturing,
On 10.09.2019, the NMPA (National Medical Products Administration) announced changes to the procedures regarding cosmetics sample tests in China (No. 72-2019), followed by an interpretation of their announcement on 12.09.2019. Laboratories – that perform sample tests for cosmetics NMPA approval – need to re-apply for their qualification as a testing institutions because the relevant qualification
From 01.01.2020, every products must have a Marketing Authorization Holder (MAH), which is responsible for the entire supply chain, including the production and distribution of the product. This information is misleading. In China, the MAH is the manufacturer himself. The foreign manufacturer/MAH must authorize a legal representative in China as his NMPA Legal Agent.
In accordance with the NMPA (National Medical Products Administration) publication No. 66-2019, the UDI (Unique Identification System) will be mandatory for medical devices in China as of 01.10.2019. There are currently the following two relevant guidelines: • Rules for the Unique Identification System of Medical Devices • YY / T 1630-2018 Fundamental Requirements for UDI
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
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 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
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 29.06.2019, NMPA minister Jiao Hong attended a press briefing – held by the general office of the NPCSC (The Standing Committee of the National People’s Congress) – regarding the vaccine administration law. Jiao Hong stated to implement a very strict administration over vaccines. The Law clearly defines a stringent management system, vaccine development, production,