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
Low insurance reimbursement rates in Taiwan are discouraging the development of innovative pharmaceutical products, according to a study by Fitch Solutions. Because essential healthcare for all residents of the island nation is covered by a single public system, and hospitals negotiate with... 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
Moving to improve coordination of all aspects of rare disease research and treatment, India has approved its first-ever national policy on the prevention and management of such conditions, which afflict a small percentage of the population and are costly to remedy. The... Read More
To speed the import of key new biologic agents needed to combat public health emergencies, including vaccines to help the body develop immunity to the virus that causes COVID-19, South Korea is cutting the steps required for regulatory approval of the products. The... 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
The cost of the majority of pharmaceuticals sold in Japan will undergo major revisions April 1, when the Ministry of Health, Labor and Welfare (MHLW) sets new prices on more than 69% of drugs marketed in the country. The revisions mean the... Read More