Key points
- From 29 November 2025, CORP applications for indication, dosage and route of administration of registered NCE products may be accepted with proof from one reference country (instead of two).
- Accepted on a case-by-case basis, subject to specified criteria.
- Aims to expedite access to expanded treatment options for patients.
A letter was issued by the Pharmacy and Poisons Board of Hong Kong ("the Board") on 3 November 2025 to inform all certificate holders of registered pharmaceutical products on the Board's endorsement to refine the requirements for applications for change of registered particulars ("CORP").
The refinement relates to indication, dosage and route of administration of registered pharmaceutical products containing New Chemical or Biological Entities ("NCE products").
In accordance with the current "Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances" ("CORP Guidance Notes") promulgated by the Board, for any proposed changes in indication, dosage and route of administration which have not been previously approved for products registered in Hong Kong, applicants are required to provide documentary proof for registration approval of the products issued by the drug regulatory authorities in two or more of the listed reference countries.
In order to further expedite access to expanded treatment options for patients, the Board has endorsed to refine the requirements for CORP applications related to indication, dosage and route of administration of registered NCE products, with effect from 29 November 2025.
Under the refined requirements, CORP applications for change of indication, dosage and route of administration for registered NCE products with documentary proof for registration approval in one of the listed reference countries (instead of two), may be accepted for evaluation on a case-by-case basis, subject to the fulfillment of specified criteria.
For details, please refer to the letter dated 3 November 2025.