Clinical Trial Exemption (CTX)

Overview

The Clinical Trial Exemption (CTX) license is issued to parties wishing to manufacture unregistered products for clinical trial purposes. This license is essential for pharmaceutical companies, sponsors, and contract research organizations conducting clinical trials in Malaysia.

Key details

Governing Act

Sales of Drugs Act 1952; Sales of Drugs Regulations 1997 (Analysis Certificate), Drug and Cosmetic Control Regulations 1984, Poison Act 1952

Agency fees

Free of charge for application.

Validity

3 years

Issuing authority

Ministry of Health

Fees shown are government / local-authority fees payable to the issuing agency. Emerhub charges a separate service fee for handling the application end-to-end.

Eligible applicants

Registered companies in Malaysia (pharmaceutical companies, sponsors, contract research organizations)

Application requirements