The Pharmacy and Poisons Board of Hong Kong (“the Board”) announced that the Refuse-to-File (“RTF”) Mechanism will be enforced in the registration application for pharmaceutical products/substances at the screening stage starting from 1 July 2024.
Generally known, all pharmaceutical products must be registered under the Board to be legally marketed or supplied in Hong Kong. The Drug Office of the Department of Health is the primary body responsible for conducting the initial screenings of all documents submitted through the Pharmaceutical Registration System 2.0 (“PRS 2.0”) before proceeding with further evaluation procedures.
A Deficiency Letter will be issued for any outstanding information and at the time being there is no deadline for the applicant to reply to the letter. Hence, the Board announced the new initiative via the RTF Mechanism which required applicants to respond within a 60-day timeframe upon receiving the deficiency letter.
1) For new applications submitted for screening on or after 1 July 2024
Applicants will be given a 60-day timeframe to respond to the deficiency letter if there is outstanding information required for further review. Failure to respond within this timeframe will result in the application being rejected for filing in the PRS 2.0 system.
2) For applications that are already in the screening stage before 1 July 2024
For cases in which the deficiency letter was issued before 1 July 2024, applicants may respond to the letter on or before 1 September 2024. Applications will be refused for filling into the PRS 2.0 system if no response is received during the timeframe given.
For cases in which the deficiency letter was issued on or after 1 July 2024, the applicants have a 60-day timeframe to respond with the outstanding information. Applications will be refused for filling into the PRS 2.0 system if the applicants do not respond within the timeframe given.
However, the filling refusal does not preclude the new registration application submissions. Applicants were advised to ensure all the dossiers were completed to avoid unnecessary delays or market interruption. Good cooperation given by the applicants can effectively assist the committee in enhancing the efficiency of managing the reviews during the screening stage.
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