Hong Kong now an official observer for international drugs regulator ICH

Hong Kong has been accepted as an observer of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Department of Health announced on Thursday. 

The ICH is an internationally recognized association. Its latest expansion saw a total of 21 members – comprising drug regulators from the mainland, Europe, Switzerland, the UK and the US – and 37 observers. 

The decision was made last Tuesday (Oct 31) at the assembly meeting held in the Czech Republic. 

The department said this is an important step for Hong Kong in moving towards the establishment of a registration mechanism for drugs and medical devices based on “primary evaluation” in the long run. 

Secretary for Health Lo Chung-mau was delighted by the good news and said: “Our objective is to take progressive steps to bloom from the current ‘secondary evaluation’ approach towards the establishment of a ‘primary evaluation’ approval mechanism recognized internationally and by the mainland. 

“In that event, approval of drugs, medical devices and technologies in Hong Kong will no longer rely on the approval from other reference drug regulatory authorities but directly based on supporting clinical data and expert advice. 

“This would enable patients to get early access to new drugs, and at the same time attract more local, mainland and overseas pharmaceutical and medical device enterprises to conduct research and development and clinical trials in Hong Kong,” Lo said. 

Lo continued that the “primary evaluation” approach can gradually build up the capacity, recognition and status of the approval mechanism for drugs and medical devices of Hong Kong to ensure that the eventual mechanism would be widely recognized by the mainland and internationally. 

The health chief also recalled that the ‘1+’ mechanism for registration of new drugs has been implemented on November 1, one of the key initiatives announced in this year’s policy address. 

The department said becoming an ICH observer will lay the foundation for Hong Kong to achieve the ultimate goal of becoming an ICH regulatory member.