Clinical Trial/ Study is important for the development of a medical devices whereby it give the conformance of product safety and performance with regard to use with human.
1. Great infrastructure in the specialties such as:
a. Cardiology,
b. Gastroenterology,
c. Respiratory,
d. Oncology, and
e. Endocrinology.
2. Government supportive regulatory to make Malaysia a preferred clinical research destination
3. Regulatory and ethics submission document language of both malay and english
4. Parallel and fast approval timelines
5. Quick start-up timelines
6. Lower per-patient costs and Institutional Review Board (IRB) fees compared to most countries
7. Medical device and non-interventional studies require only Institutional Ethics Committee (IEC) approval
Landscape of Malaysian population
32 million people, of which Malays and Indigenous (60%), Chinese (28%), Indian (8%), and others
72.8% reside in urban centers
95.4% literacy rate
Malaysia has a wide ethnic population as above, which helps in testing the drug in multiple ethnic groups.
Malaysian government initiatives
The government of Malaysia, with an aim to promote and increase the number of clinical studies in the country, established Clinical Research Malaysia (CRM) in 2012. The objectives were to effectively increase the speed, reliability, and delivery of outcomes.
Clinical trial status in Malaysia
A total of 1,490 clinical trials are conducted in Malaysia with 374 ongoing studies as per clinicatrials.gov. (Data as of April, 21), and this shows the interest of researchers to perform their clinical trials in Malaysia.
Therapeutic areas for clinical trials in Malaysia
Currently, the major therapeutic areas to perform clinical trials in Malaysia are:
Heart disease and Stroke
Influenza and Pneumonia
HIV/AIDS
Tuberculosis
Diabetes
Recent achievements of the clinical trials in Malaysia
Clinical trials of new Hepatitis C combination treatment held in the country have shown not only a high 97% cure rate but also better efficacy of treating the most severe form of Hepatitis.
Hospital Miri, Sarawak has been the 2nd top recruiter globally for a respiratory study recently.
Hospital Kuala Lumpur was among the top 2 recruiters for a Cancer Registry study in Asia.
The government signed MoU’s with CROs to attract more global trials into the country.
Need support to conduct your clinical trial in Malaysia?
Regulatory for clinical trials in Malaysia
There are mainly two agencies regulating clinical trials in Malaysia
a. National Pharmaceutical Control Bureau (NPCB) or
b. Medical Device Authority (MDA)
Agencies reviewing the clinical trials
Institutional Review Board (IRB)s, including the Medical Research & Ethics Committee (MREC) for trials using the Ministry of Health (MOH) Malaysia facilities or
Local IRBs for non-MOH facilities.
The National Pharmaceutical Regulatory Agency (NPRA) ensures the quality, efficacy, and safety of pharmaceuticals. Additionally, it also acts as a secretariat to the Drug Control Authority (DCA), which
Clinical trial approval process
Following the guidelines for CTIL/CTX, the CTIL/CTX applications are submitted to the NPRA.
The NPRA screens the application dossier for completeness before handing them over to the DCA to make a decision.
PI/CRO/sponsor, who intends to submit to MREC, needs to register in the National Medical Research Register (NMRR) website and get a user account. This user account can be used for all submissions thereafter.
CTIL/CTX application is processed in 30 working days, while the MREC approval process takes 50 working days (if no amendments to the submitted documents are required).
Both CTIL/CTX and MREC applications can be submitted in parallel.
If the DCA and MREC grant approval (or other accepted IRB/IEC), then the NPRA issues the CTIL/CTX and regulatory approval letters to begin the clinical trial.
