Category Archives: Pharmaceutical

Ever since the World Health Organization (WHO) defined “Pharmacovigilance” as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems” in 2002, the concerns of pharmacovigilance have kept widening. To date, aspects including herbals, traditional and complementary medicines, blood products, biologicals, medical devices, and…

Good news: on October 14th, China’s National Medical Products Administration (NMPA) has announced an extra 80 to 160 days extension for the submission of drug supplementary dossiers to China’s Center for Drug Evaluation (CDE) for drug registration (No. 86 of 2022). The temporary extension of the timeline for submission of supplementary materials for drug registration…

In 2021, China’s Center for Disease Evaluation (CDE) has rejected 542 drug registration applications. 359 rejected applications were due to failure of submitting supplementary dossiers in time (hereinafter “Exceed Deadline”), accounting for 66.3% of all rejected applications. The overdue cases included applications of 9 Traditional Chinese Medicine (TCM), 349 chemical drugs, and 1 biological product.…

The newly released 2021 Drug Review Annual Report by China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) data shows that China has achieved doubling of drug approvals in 2021 compared to prior year. More importantly, it suggests the determination of Chinese authority to encourage more New Drugs to the market by…

The beginning of June has seen the release of 2021 Drug Review Annual Report by China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA). In 2021, the drug review work has achieved new records by accomplishing 47 innovative new drug approvals. In addition, the completion rate of on-time review & approval of…

On June 7, 2022, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the Annual Report on Progress of Clinical Trials for New Drug Registration in China (2021). CDE and NMPA’s annual report represents a comprehensive summary and analysis of clinical drug trials for new drugs within the last 3…

China has been implementing reforms of drug registration review and approval since 2015, including a variety of regulations issued to improve the quality of generic drugs. Under the new regulatory framework, the quality and efficacy consistency evaluation of generics has been put into force, the Abbreviated New Drug Application (ANDA) requirements have beenimproved and harmonized…