Taiwan Published Guidelines for Decentralized Measures for the Implementation of Drug Clinical Trials

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling
Taiwan Food and Drug Administration published Guidelines for Decentralized Measures for the Implementation of Drug Clinical Trials. Below is a summary of the guidelines:
  • Purpose and Concept: The document begins with an introduction that outlines the purpose and concept of decentralized measures in clinical trials.
  • General Considerations: Section 2 discusses general considerations when implementing decentralized measures, including reducing face-to-face interactions, the impact on data integrity, reasons for implementation, and…
More details on this document can be found on the RegASK Platform. 

Sorry, this premium content is for RegASK clients only.

Want to access the whole content of the alert or browse all the news? 

Have a
regulatory affairs
challenge?

Regulatory Affair Icon