On June 20th, China National Health Commission (NHC) officially announced the draft list of 1st batch of encouraged generic drugs (NHC is a ministry-level institute of the State Council, in which the Department of Drug Policy and Essential Medicine takes the responsibility of improving the national essential medicine system and establishing national drug policies and…
Ministry of Ecology and Environment of PRC (China MEE) recently published a Notice to announce it has reopened the channel to allow chemical industry to apply for chemical supplementary into Existing Chemical Inventory in China. Existing Chemical Inventory in China, as known as Inventory of Existing Chemical Substance in China (IECSC), was published by China…
On December 26, 2018, China NMPA (National Medical Products Administration) released the Regulations for Drug and Device Overseas Inspection. Drugs and devices that have been approved or are applying for market in China are subject to this Regulation. The working procedure are summarized in the diagram below. And in the first half of 2019, there…
On May 29th, 2019, China CDE published the Key Considerations in Using Real-World Evidence to Support Drug Development (Draft Version) for public review. And it’s the first time the concept of Real World Evidence (RWE) was clearly stated by China CDE. This Key Considerations (Draft) contains five main parts including 1) Introduction, 2) The Definition…
Since the Quality Consistency Evaluation (QCE) reform has been implemented nationwide in 2016, there are two questions all pharmaceutical companies in China facing: whether to initiate a QCE project? If yes, what kind of generic drug should be selected? And since the medical insurance policies for generics such as 4+7 (11 pilot Chinese provinces) hospital…
