Hong Kong Drug Office has published a guidance note on the registration of pharmaceutical products containing a new chemical or biological entity (NCE) in August 2021.
The aim of the document is to provide guidance on making application for registration of pharmaceutical products containing NCE. The document outlines the procedures and additional requirements for the registration and applicants should read the document in conjunction with “Guidance Notes on Registration of Pharmaceutical Products/Substances”, where applicable.
The additional requirements are:
- Official evidence of registration approval of the product in two or more of the reference countries (listed in the official guidance document).
- ICH CTD Module 2 (or equivalent).
- Evaluation report(s) on the safety, efficacy and quality of the product signed by expert(s) and the expert’s curriculum vitae.
- Proposed Risk Management Plan (RMP) and/or Risk Evaluation and Mitigation Strategy (REMS) to be implemented in Hong Kong.
- Proposed package insert of the product and prescribing information leaflet for healthcare professionals.
- Risk assessment report of elemental impurities in accordance with ICH Q3D.
- Information of any pre-registration importation of the product in Hong Kong, and clinical trial information.
- Comparison of the therapeutic indications, dosage, and other aspects between the application and authorizations for the same product in other countries/regions.
- Worldwide registration status of the product.
- Any other countries/regions where the product’s authorization was refused/suspended/revoked by the competent authorities.
The document also contains information on special considerations, pharmacovigilance requirements, sales control on new chemical or biological entity, and the applicability of NCE requirements.
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