China: CDE Rejected 542 Drug Applications Last Year
Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons…
Address: A38, Beilishi Road, Beijing 100810, P.R. China
Tel: +86-010-68310909
Web: http://www.sfda.gov.cn/WS01/CL0001/
The State Food and Drug Administration (SFDA) is founded on the basis of the previous State Drug Administration.
The State Food and Drug Administration is directly under the State Council of the People’s Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.
Regulatory
Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons…
China’s strict ‘dynamic COVID-zero’ policy, relying on lockdowns, mass-testing and border controls to stamp out COVID-19 outbreaks wherever they appear, has undoubtedly constricted the country’s economic growth and prompted uncommon…
DIA Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from 2019 through 2021:…
A roundup of some of the biggest recent stories from Chinese pharma, including Moderna’s refusal to divulge its mRNA IP, Advanced MedTech’s acquisition of urology leader WIKKON and Menarini’s AMR…
Despite the impact of the COVID-19 pandemic and the vagaries of the country’s restrictive ‘dynamic zero COVID’ policy, the Chinese pharmaceutical industry is expected to continue its remarkable trajectory up…
China healthcare and life sciences news. Top stories include the NMPA approvals of CanSino’s inhaled COVID-19 vaccine and AstraZeneca’s CKD treatment, HitGen/Unison’s anti-infectives deal and the funding secured by cell…
A selection of the latest stories from Chinese pharma, including Novartis’ bet that the country will become its second biggest market by 2024 through the introduction of 50 new drugs,…
Some of the most significant recent stories emanating from Chinese healthcare and life sciences, including why the development of a domestic mRNA COVID vaccine – widely acknowledged as an essential…
Due in part to an increasingly encouraging regulatory environment, China continues to strive for progress in cell and gene therapies (CGT). In fact, according to a 2021 Nature study, CAR…
Writing in the May edition of DIA’s Global Forum magazine, Xu Wang of Novo Nordisk China looks at the new drug approvals in China in 2021. Among other highlights, the…
Writing in the April edition of DIA’s Global Forum magazine, the DIA China Leadership and Career Community look at the Chinese pharmaceutical innovation ecosystem’s R&D talent gap and the China Pharmaceutical R&D…
As China struggles to maintain its ‘dynamic zero-COVID’ policy in the face of Omicron variant outbreaks, other key talking points emerging from the world’s second-largest healthcare and life sciences market…
See our Cookie Privacy Policy Here
