China’s NMPA Introduces New Revised Regulation for Drug Approval by Foreign Companies

Overview: China’s National Medical Product Agency (NMPA) proposes a revision on pharmaceutical approval. The revision focuses mainly on generic drugs and how to increase the safety requirements for clinical trials, limit false clinical data and encourage drug approval process. China additionally released the second batch of urgently needed drugs from foreign manufacturers.  New Drug Review …

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Japan’s MHLW Allows Online IRB Meetings for Coronavirus Trials

Japan’s MHLW issued on April 1, allowing institutional review board (IRB) meetings to be held online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.

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