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Hong Kong Launches Expedited Drug Registration Process & Becomes ICH Observer

 
• By Vibha Sharma

Hong Kong is taking incremental steps to move towards a system where it can evaluate and approve new drugs more quickly and efficiently on its own. The moves include preparations for a new Hong Kong Centre for Medical Products Regulation.

The national flag of Hong Kong on a capsule and pills on a spoon
Hong Kong Is Gradually Building Capacity To Be Able To Undertake Independent Drug Evaluations • Source: Shutterstock

As part of ongoing efforts to strengthen its drug evaluation capacity, Hong Kong has launched a new streamlined mechanism, called “1+”, to speed up the registration of pharmaceutical products containing new chemical or biological entities for life-threatening or severely-debilitating diseases.

Hong Kong currently relies on prior approvals granted by regulators in 36 reference countries to enable local drug registrations, but is keen to progress towards the “primary evaluation” model under...

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