New drug applications (NDAs) refer to applications for initial registration of pharmaceutical products containing new chemical or biological entities, Advanced Therapy Products (“ATPs”), and related applications. Please see Table 1 of the “Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications” for the categorization of NDAs.
Phase 1 of primary evaluation covers chemical entities with effect from 31 March 2026 while primary evaluation of biological entities and ATPs will be implemented at a later stage. For details, please refer to "The Hong Kong Centre for Medical Products Regulation - Towards Primary Evaluation":
www.dh.gov.hk/english/main/main_pocmpr/files/cmpr_infobro202506_e_tc.pdf
As mentioned in "The Chief Executive's 2025 Policy Address", the Hong Kong Special Administrative Region Government would establish the Hong Kong Centre for Medical Products Regulation in 2026 and begin the phased implementation of primary evaluation mechanism for new drug registration in the same year.
The Department of Health has begun the phased implementation of primary evaluation for new drug registration. The initial phase covers applications for the registration of drug products containing locally registered chemical entities with extended applications (e.g. new indications, new strengths, new posology, new dosage forms, etc).
The Drug Office has prepared the following briefing video to facilitate traders to understand primary evaluation.
Primary evaluation
