Last month, PBM’s newsletter outlined how Hong Kong is becoming more advanced in clinical research. On October 31, Hong Kong’s Pharmacy and Poisons Board was allocated “observer status” with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Observer status will help Hong Kong become more knowledgeable about ongoing global drug registrations and help strengthen its relationship with the WHO.
Currently, drugs are registered in Hong Kong once an application is submitted, and the drug has received approval from two other respected regulatory agencies (i.e., US, EU, and Australia). In this scenario, Hong Kong is not considered the main evaluator of the drug. In the future, Hong Kong wants to become the main evaluator of a drug via successful clinical data without piggybacking off of two third-party country regulators. In an effort to hasten drug approval in Hong Kong, last month, a new mechanism called “1+” was introduced. For life-threatening or rare disease drugs, conditional approval can now be granted based on strong clinical data and drug approval from only one foreign regulatory agency, not two.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article:https://www.scmp.com/news/hong-kong/health-environment/article/3240885/hong-kong-joins-global-drug-regulator-body-observer-bringing-city-closer-setting-own-approval