Attracted by Shanghai government policies designed to encourage the development of the pharmaceutical industry, Western drug manufacturers are setting up shop in China’s financial hub. The biopharmaceutical firms are partnering with Chinese industry leaders, taking advantage of a reservoir of talented biopharma... Read More
In an across-the-board effort announced by the Chinese government in May, the country’s health regulators are making plans to strengthen oversight of the manufacture, import and distribution of pharmaceuticals. The announcement from the General Office of the State Council outlined a range... Read More
Moving to systematize the settling of patent disputes, Chinese health regulators are testing an online patent linkage system designed to connect the approval for marketing of generic drugs with the expiration of innovative drug patents. The system puts into effect patent linkage... Read More
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