Hong Kong: From today onwards, the phased implementation of the "first level approval" new drug registration mechanism will be carried out.

In order to promote the development of new drugs, the Hong Kong Department of Health announced today (March 31) the phased implementation of the "First Level Approval" new drug registration mechanism. The first phase covers the extension of drugs containing "chemical elements already registered in Hong Kong", such as those used for new indications, new doses, new methods of administration, and new dosage forms, and is now accepting registration applications. The department has informed pharmaceutical organizations and stakeholders and will conduct online seminars next month to explain the details. The Hong Kong government previously proposed to establish the "Hong Kong Drug and Medical Device Regulation and Management Center" within Hong Kong this year and to implement the "First Level Approval" in stages in the same year, with the goal of fully covering all drug products by 2030. The government launched the "1+" drug approval mechanism on November 1, 2023, and 19 new drugs have been approved so far, with 7 already included in the Hospital Authority's drug formulary. The Hong Kong Department of Health stated that the "First Level Approval" is a comprehensive new drug registration regulatory program that includes independent evaluation of original data such as preclinical trials (animal testing), clinical studies, drug surveillance, manufacturing, and quality control to ensure the safety, efficacy, and quality of drugs before and after marketing (throughout the product lifecycle). Approving new drug registration applications through the "First Level Approval" method does not require reliance on or waiting for non-local registration permits, allowing for faster introduction and clinical application of new drugs, achieving the goal of "good drugs for Hong Kong, good devices for Hong Kong". The "Office for the Introduction of Innovative Drugs and Medical Devices" of the Hospital Authority will proactively contact manufacturers of innovative drugs and devices after determining the local patient needs and benefits of innovative drug therapy, making use of the "1+" mechanism for registration, and introducing innovative drugs and devices that are in the best interest of patients and cost-effective into Hong Kong.