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Learn more about new policies and challenges of drug registration in China from Jianqing Chang, VP of Drug Regulatory Policy, Tigermed.
A deep interpretation of newly updated Measures for the Administration of Drug Registration in China.
After the pilot program in ten provinces and municipal cities for 3 years, the MAH system becomes one of the twelve chapters of the revised Drug Administration Law, which was put into effect since De 1, 2019.
On March 30, 2020, the revised Drug Registration Regulation (DRR) was issued by the State Administration for Marketing Regulation and will be put into effect from July 1, 2020
Full translation of newly updated Drug Registration Regulation published by China’s National Medical Products Administration (NMPA) which will be effective July 1, 2020.
A recent study, in which Tigermed’s Central Lab participated, shares insights into the effects of lopinavir-ritonavir in hospitalized adult patients with severe Covid-19.
For Chinese-Foreign cooperation clinical trials，the HGRAC is an integral part of the initiation process, even if you are not planning to export any of the below-mentioned genetic materials or “export” of information related to such materials.
In this article, you will find a succint overview of 4 different strategies that pharmaceutical companies can apply if they are pursuing the approval of their drug product in China. Although this emerging market is seemingly a great source for increased revevues, it does beg to question if the regulatory hurdles are worth the investment.