China And Taiwan Move Toward Clinical Data Mutual Acceptance, Regulatory Harmonization
This article was originally published in PharmAsia News
China and Taiwan's top health regulators have signed an agreement to harmonize clinical and non-clinical studies toward mutual data acceptance. The deal could open doors for more Taiwanese drugs in the Chinese market, industry experts say
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Bayer Global Regulatory Affairs Head Joseph Scheeren On MRCT In China: An Interview With PharmAsia News
The possibility China may scale back the acceptance of Multi-Regional Clinical Trial (MRCT) data has become a hot topic between China FDA and industry. On the sidelines of a recent special Asia Pacific Economic Cooperation (APEC) meeting on regional clinical trials, Joseph Scheeren, head of global regulatory affairs for Bayer, shares his views.
Taiwan’s new fast-track NDA process is expected to reduce review time from 360 days to 200, or even less for three categories of drugs.
Cooperation is needed between pharma partners in addition to implementation of cross-strait agreements.