Plans by China to create a free trade port in Hainan province, which have moved forward swiftly this year, bolster opportunities for the growth of the country’s pharmaceutical industry. They are also likely to lower prices on imports for Chinese consumers who... Read More
Medical research in China involving humans will be subject to ethical reviews to ensure privacy, safety, and fairness, if a draft proposal released by the National Healthcare Commission (NHC) becomes law. The proposal would require research and healthcare institutions to create or... Read More
By December 1, 2021, according to the NMPA’s recent release on new Pharmacological Vigilance Quality Management Standards, Marketing Authorization Holders (MAHs) in China will have new pharmacological vigilance responsibilities. MAHs will need to have a dedicated pharmacovigilance team to deal with risk... Read More
New medical devices for treating rare diseases and urgent public health needs will be subject to speedier evaluation and approval in China as part of a new set of medical device regulations published by the National Medical Products Administration (NMPA). The regulations,... Read More
A major state-sanctioned political party in China made up primarily of medical and health science researchers is calling for making rare disease treatments eligible for government health insurance reimbursement. The public plea this spring by the Chinese Peasants and Workers Democratic Party... Read More
To streamline the collection of data on raw materials used in the manufacture of medical devices, Chinese regulators in March established a voluntary registration system for suppliers. Under the system, applicants for sales permits for many medical device products may register a... Read More
The viability of marketing home-use genetic collection kits to consumers in Asian markets is growing, bolstered by government incentives, increased consumer awareness of their own healthcare needs and improvements in the technology behind the kits themselves. The kits employ state of the... Read More
More than two dozen medical devices with documented track records of safety are now exempt from the clinical trials previously required of the Chinese authorities, saving manufacturers of the devices the expense of conducting the costly trials in order to be approved... Read More
Seeking to better control costs of hospital stays, China is taking steps to adopt a payment classification system batching cases that are clinically similar and are expected to use the same levels of hospital resources into groups for the purposes of determining... Read More
With China ahead of other major global economic powers in its recovery from the COVID-19 pandemic, its biopharmaceutical industry is surging, driven by its increased capacity for research and development, growing investment in the sector from venture capital firms and a series... Read More