Updated on 26 September 2012
Basic documents, including a copy of business registration certificate, covering letter, authorization letter from manufacturer, manufacturer's license, GMP certificate, free sale certificate from the country of origin, prototype sales pack, proposed package insert, if applicable, document(s) to support the proposed indication, dosage and other information in package insert or sales pack label, scanned image or photo of the product and primary container, master formula and finished product specification are required.
Core documents that are required, include document(s) showing compliance with reference pharmacopoeia, documents elaborating the method of analysis, certificate of analysis, stability test data, bioequivalence data (for anti-epileptic drugs), and TSE information on animal-origin materials, if applicable, is required.
Drug registration process is getting vigilant in Hong Kong and the manufacturer needs to submit additional information, such as, documents to support the information in the expert evaluation reports on safety and efficacy; Information on worldwide registration status of the product, including withdrawal or refusal; licensing conditions imposed by overseas drug regulatory authorities, if applicable; and information on pharmacogenomic issues identified during drug development process, if applicable, needs to be submitted.
Furthermore, approved product information from reference country to support the proposed package insert and overseas legal classification status of the product (usually for OTC medicine) needs to be submitted.
(As shared by Ms Sabrina S K Chan, executive director, Hong Kong Association of Pharmaceutical Industry during 'Pharmaceutical Regulatory Summit' held in Singapore during August 2012. To know more about regulatory-related issues in Hong Kong, visit www.dh.gov.hk)