The Department of Health today announced that the "1+" mechanism for the registration of new drugs set forth in the Policy Address has been endorsed by the Pharmacy & Poisons Board and will come into effect on November 1.

Under the Pharmacy & Poisons Ordinance, pharmaceutical products must satisfy the criteria of safety, efficacy and quality for registration before they can be sold or supplied in Hong Kong.

According to existing requirements, applicants for the registration of new drugs are generally required to provide, among others, documentary proof for registration of pharmaceutical products issued by drug regulatory authorities from at least two reference places for rigorous evaluation before placing in the market.

Under the "1+" mechanism, applications for the registration of new drugs beneficial for treatment of life-threatening or severely debilitating diseases that are supported with local clinical data and scope of application recognised by a local relevant expert should submit approval from one reference drug regulatory authority, instead of the aforesaid two, and could submit application for registration in Hong Kong.

The department said the newly established mechanism will allow Hong Kong to expedite the approval of such applications and strengthen the city's capacity of drug evaluation in the long run.

Click here for more details about the "1+" mechanism.