China Expects Earlier Start Of National Marketing Authorization Holder System

After one year of testing the waters, China’s Drug Marketing Authorization Holder system is likely to have an earlier than expected start to the launch of final law amendment procedures, since the pilot scheme has significantly reduced investment duplication and encouraged pharma companies to file more innovative drug applications.

Beijing

Since the Drug Marketing Authorization Holder (MAH) system was rolled out in 10 provinces in China under a trial program last year, coupled with support from local financial subsidies, China’s FDA had received 381 MAH applications by June this year, including some for global novel drugs.

Given the positive feedback, the new system is now expected to be promoted nationwide, and the details of implementation are...

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