Malaysian business licence·Federal

Clinical Trial Import Licence (CTIL)

Issued by Ministry of HealthDangerous Drugs Act 1952; Dangerous Drugs Regulations 1997 (Analysis Certificate); Control of Drugs and Cosmetics Regulations 1984; Poison Act 1952

Overview

The Clinical Trial Import Licence (CTIL) is issued to parties wishing to import unregistered products for clinical trials in Malaysia. This licence is essential for pharmaceutical companies, sponsors, and contract research organizations involved in clinical research. It permits the importation of specific products for testing purposes.

Key details

Governing Act

Dangerous Drugs Act 1952; Dangerous Drugs Regulations 1997 (Analysis Certificate); Control of Drugs and Cosmetics Regulations 1984; Poison Act 1952

Agency fees

RM 500 processing + RM 500 annual

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

- Refer to the link for Clinical Trials guidelines - Complete the application forms for CTIL - Ensure compliance with Malaysian Good Clinical Practice (GCP)

Agency fee breakdown

New Application: RM500 / product. The CTIL is valid for 3 years from the date of issuance. Uncollected CTIL after 6 months of issuance shall be cancelled unless otherwise justified. Receipt for processing fee, if applicable Every application for CTIL shall be accompanied by a processing fee. The CTIL application processing fee is RM 500.00 per product. CTIL application without the correct processing fee will not be processed. (See 4.3.1) The processing fee shall be paid in the form of credit card/bank draft/money order/postal order payable to 'Biro Pengawalan Farmaseutikal Kebangsaan'. Alternatively, the payment can be made using credit card at Finance, Account & Revenue Section. Note: Foreign currencies are not acceptable. The processing fee is not refundable.

These are amounts payable to Ministry of Health. Emerhub's service fee is quoted separately when you engage us.