What is a “Clinical Trial Certificate” (CTC)? How does it relate to pharmaceutical product registration?

A Certificate for Clinical Trial (CTC) is a necessary authorisation for conducting clinical trials of medicines. In Hong Kong, any trial involving humans (patients or healthy volunteers) and intended to study the effects or reactions of a pharmaceutical product must first be applied for and obtain a CTC from the Department of Health. A CTC application requires detailed trial protocols, the Investigator’s Brochure, approval documents from the ethics committee, quality data for the investigational medicines and other materials. A CTC and drug registration are two different but related concepts. Clinical trials are usually conducted before drug registration to collect data on the safety and efficacy of the medicine in humans. These data are among the core technical documents required for a subsequent drug registration application (HK-XXXXX). In short, a CTC is an authorisation sought for “research”, while drug registration is sought for “sale”. Clinical trials conducted in Hong Kong must comply with the internationally recognised Good Clinical Practice (GCP) standard.