The Hong Kong Drug Office has announced it will soon implement a 60-day refuse-to-file requirement for registration applications of pharmaceutical products and substances at the screening stage. Effective July 1, 2024, the Hong Kong Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee will implement a Refuse-to-file (RTF) mechanism aimed at enhancing the efficiency and timeliness of the screening process.
Hong Kong has its own approval system for pharmaceutical products, which is different from the China mainland.
Understanding the New RTF Mechanism
Under Hong Kong’s Pharmacy and Poisons Ordinance (Cap. 138), all pharmaceutical products must be registered with the Pharmacy and Poisons Board before they can be sold or supplied in Hong Kong. The Drug Office of the Department of Health in Hong Kong, responsible for supporting the Board, requires applicants to submit their registration applications via the online Pharmaceutical Registration System 2.0 (PRS 2.0). Currently, submitted documents are screened for completeness before acceptance for detailed evaluation. If there is missing information, a deficiency letter is issued, however, there is no set deadline for applicants to provide the missing details.
To improve the review process, the Committee has endorsed a 60-day response period for applicants to address any deficiencies identified during the initial screening. This mechanism aims to ensure a more efficient handling of applications and to prevent prolonged delays in the registration process.
Details of the New Screening Process
Starting from July 1, 2024, the following rules will apply:
- New applications submitted on or after July 1, 2024:
- Upon screening, if an application is found to have missing information, a deficiency letter will be issued.
- Applicants will have 60 days to respond and provide the necessary information.
- Failure to respond within 60 days will result in an automatic refusal of the application in the PRS 2.0 system.
- Applications already in the screening pool before July 1, 2024:
- If the latest deficiency letter was issued before July 1, 2024, applicants must respond by September 1, 2024. Failure to do so will result in the application being automatically refused.
- If the latest deficiency letter is issued on or after July 1, 2024, the 60-day response period will apply. Failure to respond within this timeframe will lead to an automatic refusal of the application.
Implications for Applicants
It is crucial for applicants to ensure that their dossiers are complete before submission. Under the RTF mechanism, applications may be refused if the outstanding information is not provided within the specified timeframe. However, a refusal does not prevent the submission of a new application. To avoid unnecessary delays, applicants are encouraged to submit thorough and complete dossiers and respond promptly to any deficiency letters. This update underscores the regulatory authority’s commitment to streamlining the registration process, ensuring that pharmaceutical products are evaluated and approved in a timely manner. Applicants are advised to familiarize themselves with the new requirements and adjust their submission processes accordingly to comply with the enhanced screening procedures. For any questions or further clarification, applicants can contact the Drug Office at 3974 4175. By implementing these changes, the Hong Kong regulatory authority aims to improve the efficiency and effectiveness of the pharmaceutical registration process, ultimately benefiting both the industry and public health.
Further information
Read the original announcement about the RTF requirement issued by the Hong Kong Drug Office.
Cisema can help you navigate the new RTF mechanism in Hong Kong, ensuring your application dossiers are complete and compliant. We also support to integrate your efforts with the Greater Bay Area (GBA) connected scheme, facilitating the entry of overseas products through Hong Kong into the China GBA market. Partner with Cisema to streamline your registration process and explore new market opportunities. Contact us to learn more.
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