China FDA Proposes Sweeping Reforms To Incentivize Innovation
The China FDA releases a raft of new regulatory proposals outlining fundamental changes in areas including patent linkage and data exclusivity, which look set to profoundly impact decision makers looking at bringing new drugs and devices to the world’s second-largest pharma market.
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2017 may become a banner year for the China FDA as the agency officially joined the ICH process and began aligning more closely with the US FDA, approving over 25 innovative new drugs so far with an increasing focus on treatments for cancer, hepatitis and orphan diseases.
Allowing early stage Phase I studies, setting a 60-day period for IND approvals, and dropping a requirement for hospital to get certified, the China FDA proposes fundamental changes that would allow any qualified sites to file for approval to get studies rolling.
The China FDA has outlined a raft of new measures to streamline the development and approval process for foreign new drugs, in changes that are likely to quicken the pace of launches to potentially overcome China’s “drug lag” and that may also bolster multinationals’ interest and activity in the country.