Authorization Holder Scheme To Shake Up China R&D, Drug Production
This article was originally published in SRA
When a roomful of attendees at the annual ChinaTrials meeting, held Nov. 4 in Beijing, voted that a planned marketing authorization holder (MAH) system would be the single development likely to have the most impact on the pharma industry, few predicted that the scheme would come true just hours later.
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As China enacts reforms to open up to novel drugs, companies must rapidly change their approaches and adopt new business models to seize the window of opportunity, industry insiders tell a recent partnering event in the country.
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.
China’s drug regulators have had plenty of views to offer at recent major government congress sessions in Beijing, which provide a forum for the industry to meet officials and opportunities to outline reform progress and planned policies.