PUTRAJAYA, April 5 — The Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption for Unregistered Products for Clinical Trial Purposes (CTX) for “first in human” (FIH) clinical trials can now be applied for, according to the Ministry of Health (MOH).
It is in line with the seventh edition of the Malaysian Guideline for Application of Clinical Trial Import License and Clinical Trial Exemption produced by the National Pharmaceutical Regulatory Division (NPRA) in 2021, as a guide for the industry regarding regulatory requirements to apply for permission to manufacture or import research products used in clinical trials in Malaysia, including FIH clinical trials.
MOH Pharmaceutical Services senior director Norhaliza A Halim said FIH could be applied for products categorised as new chemical entities, herbal products with high demands and biologic products (excluding cell and gene therapy products).
“The 395th Drug Control Authority (DCA) meeting on April 4, 2024, has taken note of the first CTIL approval for a biologic product to be used for FIH clinical trial purposes.
“The DCA meeting was also informed that the approval of the CTIL application for this biologic product is for the treatment of advanced solid tumors,” she said in a statement today.
Malaysia is the first country to have approved the clinical trial protocol in South-east Asia alongside other countries including Spain, France, Italy, Australia, Canada, China and Japan.
According to Norhaliza, the FIH clinical trial in Malaysia will be conducted at the Sarawak General Hospital, involving 48 cancer patients.
She said the Sarawak General Hospital was among the clinical research sites accredited by the NPRA under the Phase I Unit Inspection and Accreditation Programme to conduct FIH clinical trials in Malaysia.
“MOH, through the NPRA, will continue to monitor and evaluate product safety data from time to time, including products used in all clinical trials and this FIH clinical study.
“The ministry will also continue to commit to efforts to improve Malaysians’ access to quality, safe and effective medicines,” she said. — Bernama
