On 2nd July, 2019, China CDE-NMPA published the 2018 working Report, summarizing the drug review and approval statistic data in the past year. See below for the details. 1- Overall Statistic It can be seen from Figure 1, 2, 3 and 4, the backlog of drug applications in CDE has been greatly alleviated: the application…
China has implemented a separate filing and review regime with drug products since December 2017. This was announced in the publication “Announcement on adjusting the review and approval system of drug substance, pharmaceutical excipients and pharmaceutical packaging materials (No. 146, 2017)” by CFDA (the new rule was published as Announcement No. 56, 2019). …
On June 29th, the Standing Committee of China NPC voted to approve the Vaccine Administration Law. This special legislation on vaccine management was spawned by the big scandal of Changchun Changsheng Vaccine happened in China in 2018. So the new Vaccine Administration Law mandates severe punishment for those who participate in illegal practices of vaccine…
In June time, the China National Health Commission (NHC) officially announced the draft list of 1st batch of encouraged generic drugs (details of previous news are accessible here). There are 34 drugs on this list and it includes a variety of anticancer drugs like Ixabepilone, orphan drugs such as Nitisinone, and drugs that have been in…
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…
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…
