Hong Kong: New Drug Approval Mechanism "+1" (1 November 2023)

Commencing efficiently from 1 November 2023, the Pharmacy and Poisons Board will be implementing the new “1+ mechanism” to facilitate the pharmaceutical product registration containing new chemical or biological entities (NCE products), for life-threatening or severely-debilitating diseases.

Previously according to the “Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity”, the applicants were mandated to present proof documentation demonstrating the approval of the product registration from two or more drug regulatory authorities of the reference countries.

However, through the 1+ mechanism, applicants who are not able to provide official proof of registration approval from two or more authorities of the listed reference countries, are still allowed to proceed with the new drug registration, under the condition that:

• There is a local unmet medical need for a life-threatening or severely debilitating disease products

• The product is approved with orphan drug designation, breakthrough therapy designation, priority review designation, and marketed in any of the reference countries

• There are local clinical data, clinical studies, or case reports of the product related to the proposed indication

Apart from the proof of the approval documentation, applicants were also obligated to fulfill the other requirements for NCE product registration under the 1+ mechanism:

• Justifications for non-compliance with the registration requirement for approval of a minimum 2 reference countries and proof documentation proving that the products fulfill the mechanism requirements

• Assessment reports by a local expert, with at least 5 years experience in the relevant field of the products, or equivalent, including the review of the following:

o The local and global epidemiology of the disease

o The local and international treatment paradigms of the disease

o Local unmet medical needs of the disease

o Safety and efficacy of the product

o Evaluation report of the clinical data

• The assessment report, post-authorization requirements, or/and licensing condition issued by the drug regulatory authority that granted the product approval in the reference country

• Periodic safety update report, summary safety report

• Post-registration development plan

Reference countries recognized by Hong Kong Drug Office:

Australia, Austria, Belgium, Brazil, Canada, China, Finland, Ireland, Japan, Polan, Singapore, Sweden, Switzerland, UK, USA

Source: Drug Office, Department of Health

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