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General Information
This guideline serves as a reference for the applicants of Clinical Trial Import License (CTIL) which authorizes for the import of any unregistered product and for Clinical Trial Exemption (CTX) which permits the manufacture of unregistered local product. In both instances, authority is given for the purpose of clinical trial only. CTIL is required before an unregistered product can be brought into Malaysia, and Clinical Trial Exemptions (CTXs) is issued, as permission to manufacture unregistered products in Malaysia, both for clinical trial use.
The guideline is prepared in line with the legal requirements imposed by the Control of Drugs and Cosmetics Regulations 1984, Sale of Drug Act 1952 and the Poisons Regulation (Psychotropic Substances) 1989 involving controlled substances. (1) Section I of this handbook lists out:-
- the products that require Clinical Trial Import License/Permit and Clinical Trial Exemption.
- application formalities for Clinical Trial Import License/Permit and Clinical Trial Exemption.
- details in processing the application and conditions for Clinical Trial Import License/Permit and Clinical Trial Exemption.
Every CTIL or CTX application shall be provided with complete required documents and submitted to:-
Deputy Director
Centre for Research and Compliance
National Pharmaceutical Control Bureau
Ministry of Heath Malaysia
Lot 36, Jalan Universiti
46200 Petaling Jaya, Malaysia
The processing fee for CTIL application/renewal is RM500.00 and shall be made payment to the National Pharmaceutical Control Bureau. The application for CTX is free of charge.
Under Section II recommended formats as in Annexes A (Clinical Trial Protocol), B (Pharmaceutical Data On Dosage Form), B1 (Quality Data On Herbal / Natural Products) and C (Investigator’s Brochure) are provided for the convenience of the applicants. Recommended format for finished product, standardisation of extract, manufacture of product, quality control, stability of product, containers / packaging and labeling are also specified in Annex B1 for clinical trials involving herbal / natural products with therapeutic claims.
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Contact Details
National Pharmaceutical Control Bureau (NPCB)
Biro Pengawalan Farmaseutikal Kebangsaan
Lot. 36, Jalan Universiti, 46200 Petaling Jaya
Selangor Darul Ehsan, Malaysia
Tel: +603-7883 5400
Fax: + 603-7956 2924, 7956 7075
Website: http://www.bpfk.gov.my
Reference:
- National Pharmaceutical Control Bureau, Ministry of Health. Guidelines for application of clinical trial import license and clinical trial exemption in Malaysia, fifth edition (version 2.2). Malaysia: Ministry of Health; [updated 2009 Jun; cited 2012 Dec 13]. Available from: http://www.crc.gov.my/guidelines/pdf/2%20Guidelines%20for%20the%20Application%20of%20CTIL.pdf
