On 31 March 2026, Phase 1 of Hong Kong’s “primary evaluation” regime for new drug registration came into effect, marking a milestone in the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR) and the broader transition towards a fully independent drug evaluation framework by 2030.
To implement Phase 1, the Pharmacy and Poisons Board published new and revised guidance notes for new drug applications (NDAs).[1] Under Phase 1, the Drug Office may independently assess NDAs for pharmaceutical products containing registered chemical entities with extended applications (e.g. new indications, new strengths, new dosage forms), without requiring prior approval from an overseas reference authority.
The introduction of the “primary evaluation” scheme means that there are currently three evaluation routes for registration of pharmaceutical products, as opposed to two evaluation routes prior to 31 March 2026. These are: –
- Primary evaluation: the product has not been approved in any of the reference countries/places. This route involves independent assessment of primary data of all pre-clinical trials (i.e., animal testing), clinical studies, pharmacovigilance, manufacturing and quality control, without relying on approval from non-local drug regulatory authorities. During Phase 1, this route is available only for NDA-2 and NDA-3 applications for chemical entities. A mandatory pre-NDA meeting with the Drug Office is required before submission.
- Abridged evaluation: available where either of the following criteria is met:
- there is a local unmet medical need relating to a public health emergency, communicable diseases or matters of public health importance (e.g. tuberculosis, emerging infectious diseases, antimicrobial resistance), and the product is promulgated by a reputable international health agency such as the WHO; or
- the product has been approved with an orphan drug, breakthrough therapy, priority review or equivalent designation, is currently on the market in any reference country/place, and there is local clinical data or clinical data from Chinese and/or Asian populations related to the proposed indication(s) and posology (i.e. the “1+” mechanism).
- Verification: the product is approved in two or more of the reference countries/places.
Under the new regime, NDAs for initial registration are divided into three categories: –
- NDA-1: application for registration of a pharmaceutical product containing a new chemical or biological entity(ies). NDA-1 applications are not yet eligible for the primary evaluation route under Phase 1.
- NDA-2: application for registration of a pharmaceutical product containing registered chemical or biological entity(ies), which needs to be supported by non-clinical and/or clinical data to demonstrate its efficacy and safety. NDA-2 covers various types of extensions, such as new indications, new strengths, new dose forms, new routes of administration, new combinations of registered entities, and other changes that may impact the efficacy and/or safety of the product.
- NDA-3: an application for a product previously registered under NDA-1 and NDA-2, which does not need to be supported by non-clinical or clinical data. NDA-3 covers extensions involving only quality-related or administrative changes, such as new excipient compositions, new manufacturers on label, new container closure systems or presentations, and administrative changes.
Under Phase 1, NDA-2 and NDA-3 applications for chemical entities may be submitted via the primary evaluation route. The application dossier must be organised in the Common Technical Document (CTD) format promulgated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and the specific CTD module requirements vary depending on the NDA subcategory.
Transitional arrangements:
For applications that were accepted for evaluation prior to 31 March 2026, the previous guidance notes for registration of pharmaceutical products containing new chemical or biological entities[2] remain applicable for a transitional period of one year, until 30 March 2027.
During this period, such applications will continue to be assessed in accordance with the requirements and procedures set out in the previous guidance notes under which they were submitted, and applicants will not be required to resubmit or reformulate their applications to comply with the new guidance notes. Upon expiry of the transitional period, the new guidance notes will apply to all pending applications.
The “primary evaluation” regime will be implemented in four phases, with full implementation covering all pharmaceutical products by 2030. Phase 2 will involve products containing registered biological entities with extended applications.
For further details, please refer to the official announcement (https://www.info.gov.hk/gia/general/202603/31/P2026033100705.htm).