A new commissioner has taken the reins at China's National Medical Products Administration, but the senior CCP official has so far given few clear indications about the changes he might bring.
After much speculation, Li Li was officially appointed commissioner of China's top drug regulatory agency, the National Medical Products Administration (NMPA), on 6 September.
Li, a secretary-general within the Chinese Communist Party (CCP), will ultimately oversee review, approval and postmarketing surveillance activities for all drugs, medical devices and cosmetics in the country, along with policy-making, administrative and Party-related issues
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.
A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.
While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
