Yearly Archives: 2022

On December 19, 2018, China’s NMPA released the Guideline for Collecting and Reporting of Individual Case of Adverse Drug Reactions (hereinafter “the Guideline”). Aiming to standardize the collection and reporting throughout the Adverse Drug Reaction (hereinafter “ADR”) monitoring and processing, this Guideline provides for the Market Authorization Holder (MAH) a “5+3” instruction —5 consecutive procedures…

NMPA News: China’s National Medical Products Administration (NMPA) has released for public comments a draft announcement on administration of registration renewal of chemical active pharmaceutical ingredients (APIs) in early November. It is expected that the official announcement will be finalized soon and will facilitate the Drug Master File (DMF) process in China in future. According…

China pharmacovigilance inspection is a critical part for ensuring enforcement of patient safety systems. On April 15 of 2022, China NMPA has released theGuideline for Pharmacovigilance Inspection [No. 17 of 2022]. It requires that the authority and institutions conducting the inspection shall follow the regulations in Measures for the Administration of Drug Inspection (Trial) [No.…

On October 31st, China’s National Medical Products Administration (NMPA) announced with immediate effect the suspension of import, sales, and use of Dutasteride Soft Capsules by GlaxoSmithKline (GSK). (See the original announcement here.) According to the NMPA announcement, during the on-site inspection, GSK failed to comply with China’s regulatory requirements. The inspection found that the company…

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…