Snapshot

The 1+ mechanism for approval of new drugs pathway has been developed by the of Hong Kong.

This pathway can be used where The "1+" mechanism allows Hong Kong to be more proactive to expedite the approval of applications for registration of new drugs (i.e., pharmaceutical products containing new chemical or biological entities) for life-threatening or severely debilitating diseases and also strengthens Hong Kong's capacity in drug evaluation in the long run, which is an important step in progressing toward a primary evaluation approach. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Brazil Bulgaria Canada China Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Holland Hungary Ireland Italy Japan Latvia Lithuania Luxembourg Malta Poland Portugal Romania Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Kingdom United States

The target processing time (i.e. the time period between the acceptance of an application upon payment of the prescribed fee and the decision made by the Committee) of an application for registration of an NCE product under the “1+” mechanism will be set at 150 working days. Under the target processing timeline, the “stop-clock” will be paused as evaluation of the application is paused upon request for written response sent to the applicant for supplementary documentary evidence. The “stop-clock” and evaluation of the application will be resumed upon receipt of a response from the applicant.