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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...

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