Hong Kong’s Pharmacy and Poisons Board reviewed the requirements of the list of reference countries for the registration of pharmaceutical products containing new chemical or biological entity (NCE).
Effective 1st November 2022, four additional countries (i.e. Brazil, China, Republic of Korea and Singapore) are included in the list of reference countries for the registration of NCE in Hong Kong.
Accordingly, the following Guidance Notes were updated:
(i) Guidance Notes on Registration of Pharmaceutical Products/Substances
(ii) Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity
(iii) Guidance on Application of Certificate of Drug/Product Registration – Advanced Therapy Products
(iv) Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances
For details on the list of the updated reference countries, please see the following on circular issued by Hong Kong DOH: https://www.drugoffice.gov.hk/eps/upload/eps_news/48180/EN/1/PRC%20Letter%20to%20Trade_ref%20countries_Eng_25.10.2022.pdf