China Curbs Trials; India Proposes License Suspensions — SkimNews
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- China issued new restrictions in May on investigator-initiated trials, a pathway that lets investigators begin human drug studies without central-regulator sign-off.
- China has approved 164 investigator-initiated trials under the new regulations, while just over 1,000 have been submitted for review.
- China’s loosened rules let Chinese companies test drugs in humans faster and more cheaply, prompting U.S. companies to enter China or push the U.S. Food and Drug Administration for a similar approach.
- India proposed rules requiring regulators to immediately suspend a medicine’s manufacturing license when government testing finds a quality-standard failure.
- India’s proposed standards cover impurities, sterility, active-ingredient amount and dissolution, with dissolution assessing how a drug releases its active ingredient.
- India’s proposal requires a license to remain suspended until the manufacturer completes an effective root-cause analysis and implements corrective and preventive action; regulators must verify those measures before restoration.
Why it matters: China’s May restrictions are already reshaping a pathway that had enabled faster, cheaper human trials, with 164 approvals and just over 1,000 submissions under the new regime. India’s proposal makes a failed government quality test the trigger for immediate license suspension, with licenses remaining suspended until regulators verify that root-cause analysis and corrective and preventive action have been implemented.
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