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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
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Primary evaluation
