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New China Drug Regulation Legalizes Emergency Approval Mechanism

 
• By Brian Yang

The first major revision since 2007 notably provides a legal foundation for special approvals under a public health crisis.

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CHINA REGULATION LEGALIZES FAST APPROVALS IN PUBLIC HEALTH CRISES • Source: Shutterstock

China's National Medical Products Administration (NMPA) issued a new Drug Registration Regulation (DRR) on 30 March that will take effect from July and incorporates several provisions which underline the regulatory agency’s main priorities.

One is a special review and approval mechanism that can be initiated in a public health crisis and under which...

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