Hong Kong new drug application (NDA), fulfilling the conditional requirements set out by the Department of Health (DH), will require one overseas marketing approvals instead of two.
The new mechanism for registration of New Drugs (“1+” mechanism) was announced in the Chief Executive’s 2023 Policy Address on October 25, 2023, to come into effect on November 1, 2023. Endorsed by the Pharmacy and Poisons Board of Hong Kong (the Board), the “1+” mechanism aims to streamline the registration process for new drugs, particularly those addressing life-threatening or severely debilitating diseases.
Conditional requirements of the “1+” mechanism
Under the current Pharmacy and Poisons Ordinance in Hong Kong, pharmaceutical products must meet strict criteria for safety, efficacy, and quality before selling into the market. Previously, applicants for new drug registration had to provide documentation of two reference country approvals for evaluation. However, the “1+” mechanism simplifies this process, requiring approval from just one reference drug regulatory authority, expediting the introduction of vital medications as long as the following special conditions are met:
- there is a local unmet medical need of the product for life-threatening or severely-debilitating disease(s);
- the product is approved with orphan drug designation, breakthrough therapy designation, priority review designation, or equivalent, and marketed in any of the following countries recognized by the Hong Kong Drug Office:
- Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Holland, Hungary, Ireland, Italy, Japan, Republic of Korea, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Singapore, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, UK and USA; and
- there are local clinical data (e.g. clinical studies, case reports, case series, real-world data, etc.) of the product related to the proposed indication(s) and posology.
In addition to meeting the special conditions above, the following documents will be required for the respective NDA application as well:
- an assessment report in review of the global and local epidemiology of the disease(s), international and local treatment paradigms of the disease(s), local unmet medical need of the disease(s), how the product could address the local unmet medical need, and safety and efficacy of the product; and
- evaluation report(s) on the local clinical data of the product related to the proposed indication(s) and posology (e.g. clinical studies, case reports, case series, real-world data, etc.)
Safety reports and post-registration development plan are also essential supporting documents for the application. Due to the introduction of the “1+” mechanism, the above requirements are also indicated in the new official Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity on the Hong Kong Drug Office’s website, coming into effect on November 1, 2023.
Future establishment of Hong Kong’s regulatory authority
“The Chief Executive’s 2023 Policy Address” outlines plans to set up a preparatory office for the Hong Kong Centre for Medical Products Regulation (CMPR), aiming to streamline regulatory processes and foster research and development in the medical sector. The Hong Kong Chief Executive said the public may expect potential upgrading of the CMPR as a standalone statutory body in the long run to help accelerate the launch of new drugs and medical devices to the market. The DH is committed to maintaining a drug regulatory system aligned with international standards, supporting the growth of Hong Kong’s healthcare system, and upholding international recognition for healthcare technology and clinical research.
Benefits and Future Prospects
The Hong Kong government is set to deliver multiple benefits to Hong Kong’s healthcare landscape. The “1+” mechanism will enable faster access to new drugs meeting local medical needs, providing a lifeline to patients. Furthermore, it’s expected to attract more drug development and clinical trials to Hong Kong, solidifying its position as a hub for medical research and innovation.
In the 2023 Policy Address, the Chief Executive have also set his sights for Hong Kong to join the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as an observer to acquire familiarity with and contribute in ongoing advancements of the drug regulation. This strategic move will establish the foundation for positioning Hong Kong as a globally recognized regulatory authority for drugs and medical devices in the future.
Further information
Read the Hong Kong Chief Executive’s 2023 Policy Address on “1+” mechanism.
With the upcoming “1+” mechanism and other regulatory reforms on the horizon, biotech companies from overseas and China are attracted to become key players in the evolution of Hong Kong healthcare regulations. Contact Cisema to learn more about the “1+” mechanism details and how to swiftly bring your innovative pharmaceuticals to market.
