香港药品注册.pdf

IDRAC 33562 CLINICAL RESEARCH (Hong Kong) GENERAL PRINCIPLES Recent Document Updates Date Updated Sections Certificate for Clinical Trial/Medicinal Test Notes for Oct-2011 All the text the guidance of Applicants, Amended version, Sep 2011. Under Regulation 36B of the Pharmacy and Poisons Regulations, for the purpose of conducting a clinical trial on human beings or a medicinal test on animals, a Certificate for Clinical Trial/Medicinal Test (CTC) is required. 1. How to Apply The first step in conducting a clinical trial in Hong Kong is to apply for Ethics Committee (EC) approval. The documents required are the following. • Application Form • Final protocol • Principal Investigator’s short Curriculum Vitae (CV) • Consent form – English and Chinese • Investigator’s Brochure • Written information to be given to the subject and questionnaires (if part of the research design) • Completed ‘Investigator’s Conflict of Interest Declaration Form (pre-licensing trial) • Indemnity agreement (pre-licensing trial) • Insurance policy statement / certificate (pre-licensing trial) • Some ECs may request further information (e.g., case report form). The major hospitals in Hong Kong have their own Ethics Committee. Approvals in general take 4-6 weeks depending on the EC. The second step in conducting a clinical trial in Hong Kong is to apply for clinical trial approval to the Hong Kong DOH: Applications for a Certificate for Clinical Trial/Medicinal Test should be made, by hand or by post, to the following address: Drug Registration and Import/Export Cont