Before 2006: Building the Foundations
The story did not begin with the Ninth Malaysia Plan.
By the late 1990s, Malaysia was already attracting increasing interest as a location for clinical research. International pharmaceutical companies conducting multinational studies were already applying international Good Clinical Practice standards, particularly where trial data formed part of global drug-development and regulatory programmes.
The original ICH-GCP guideline reached Step 4 in May 1996, establishing a common international framework for clinical trials. [24]
Malaysia therefore did not have to invent Good Clinical Practice from scratch. The challenge was different:
How could Malaysia build its own clinical-research system around internationally accepted standards?
In 1997, the Steering Committee for Clinical Research in Malaysia [3] was established. It brought together government, universities, professional bodies and the pharmaceutical industry in an effort to strengthen clinical research in the country.
I represented PhAMA on the Steering Committee during this formative period and participated in the subcommittees involved in developing the first and second Malaysian Guidelines for Good Clinical Practice. [4] [5]
In my July 1999 Cybermed article, I wrote about ICH-GCP and clinical trials [1]. The article discussed international standards while Malaysia was preparing to formalise its own framework.
The first Malaysian Guideline for Good Clinical Practice [4] was published in October 1999.
It adopted the basic principles of ICH-GCP, with modifications for Malaysian conditions.
Malaysia now had its own national GCP framework, helping bring investigators, institutions, ethics processes, regulators and sponsors within a more consistent system while maintaining compatibility with international ethical and scientific standards.
In 2000, the Steering Committee became the National Committee for Clinical Research (NCCR) [3].
The second Malaysian GCP guideline [5] followed in January 2004.
The evolution of Malaysian GCP from those early foundations to the current framework is discussed separately in The Clinical Trial Has Changed.
At the same time, the physical infrastructure was developing.
The Clinical Research Centre (CRC) [8] had been established in 1997, with the first fully operational CRC at Hospital Kuala Lumpur in 2000. A national hospital-based network subsequently developed.
The National Institutes of Health (NIH) [7] was officially launched in August 2003.
The concept behind NIH extended beyond simply conducting research. It envisaged a continuum from identifying research priorities, through conducting research, to using findings in health services and programmes.
Measuring Disease — and What We Did About It
Another important development was the attempt to understand not only what diseases Malaysians had, but how healthcare was responding to them.
The National Health and Morbidity Survey (NHMS) [12] increasingly provided population-level evidence about disease and risk factors.
Alongside it, the National Medicines Use Survey (NMUS) [14] examined medicines utilisation.
I served on NMUS Expert Panel 2 — Anti-Diabetics, Endocrine and Metabolic Therapeutics [14], representing Sanofi Aventis. The panel brought together clinicians, pharmacists, researchers, academia and industry, with its work reported through Malaysian Statistics on Medicine.
By 2006, therefore, Malaysia was developing not merely a clinical-research infrastructure, but a broader evidence infrastructure.
Then Came the Ninth Malaysia Plan
When I wrote about medical research and the Ninth Malaysia Plan in July 2006, Malaysia was no longer starting from scratch.
The next question was:
What should we research?
The priorities recorded in my 2006 article included ischaemic heart disease, stroke, cancer, mental illness, respiratory disease, road traffic injury, diabetes and selected infectious diseases, together with health systems, pharmaceuticals, medical devices and biotechnology. [2]
The risk factors were equally familiar: tobacco, hypertension, overweight, high cholesterol, physical inactivity, stress and alcohol. [2]
I participated in the research-priority exercises for ischaemic heart disease and diabetes.
Looking back twenty years later, what is striking is how familiar that list remains.
But persistence of disease should not be confused with failure of research.
What Did We Build?
Quite a lot.
The National Medical Research Register (NMRR) [9] followed in 2007 as part of the developing system for research registration, submission and approval.
Further editions of the Malaysian GCP guideline followed in 2011, 2018 and 2026 [6].
Clinical Research Malaysia (CRM), established by the Ministry of Health in 2012, added another part of the machinery. It helped connect sponsors, investigators and research sites, providing practical support for industry-sponsored clinical studies. [21]
In 2019, the national CRC evolved into the Institute for Clinical Research (ICR) [8], while the wider CRC network and Malaysian clinical-research ecosystem expanded.
Building a research system requires more than guidelines and laboratories. It also requires people who can organise studies, coordinate sites and help investigators deliver reliable research.
What began as an effort to establish the rules, institutions and people required for credible clinical research had become something much larger.
Malaysia had built much of the machinery of medical research.
The supplied regional chart, which cites ClinicalTrials.gov, places Malaysia first among the six countries shown for January–September 2026, with 56 sponsored studies. These are the chart’s counts, rather than verified national totals. Different sources count different things: CRM’s 2024 annual report, for example, records 267 sponsored studies approved by ethics committees that year, while this chart shows 78 for Malaysia in 2024. [19] The figures should not be treated as interchangeable.
What Did We Learn?
One of the less glamorous achievements was that Malaysia became much better at measuring itself.
NHMS evolved into a more regular source of national health information, alongside disease registries and systematic medicines-utilisation data.
We could increasingly replace impressions with data. Some of those data tell a sobering story — although national disease trends are not, by themselves, an evaluation of research funding or its effectiveness.
A Problem That Grew: Overweight and Obesity
The trend in body weight is particularly clear.
In 2006, 29.1% of Malaysian adults were overweight and 14.0% obese — 43.1% combined [10].
Using the same broad international BMI categories — overweight at 25.0–29.9 kg/m² and obesity at ≥30.0 kg/m² — the later NHMS series reported:
2011 — 44.5% [12]
2015 — 47.7%
2019 — 50.1%
2023 — 54.4% [25]
By 2023, more than half of Malaysian adults were overweight or obese.
Physical inactivity remains important, but comparisons across two decades need more caution because the instruments used to measure physical activity have changed.
Twenty-year comparisons require us to ask not only what was measured, but how it was measured.
Diabetes: Still With Us
NHMS III reported diabetes in 11.6% of Malaysian adults aged 18 years and above in 2006 [10].
NHMS 2023 reported 15.6% overall raised blood glucose [12], comprising known diabetes and people with raised glucose who had not previously been diagnosed.
But these should not simply be connected with an arrow.
NHMS 2006 used fasting capillary whole-blood glucose ≥6.1 mmol/L to identify previously undiagnosed diabetes. NHMS 2023 used fasting glucose ≥7.0 mmol/L or random glucose ≥11.1 mmol/L. The different testing and classification approaches mean the two percentages are not directly comparable. [10] [12]
Diabetes remains a major Malaysian health problem almost twenty years after it was identified as a research priority.
Hypertension: Still Around Three in Ten
Hypertension tells a somewhat similar story.
Approximately 32.2% of adults aged 18 years and above had hypertension in 2006 [10].
NHMS 2023 reported 29.2% [12].
Nearly two decades later, roughly three in ten adults still have hypertension.
Prevalence alone does not tell us whether hypertension is recognised, treated or controlled. Knowing how to treat it and achieving population control are different things.
Better Measurement Is Also Progress
Heart disease, stroke and cancer require particular care when making twenty-year comparisons.
Raw death counts can mislead.
Malaysia's population has grown and aged. Disease registration, diagnostic capability and death certification have also evolved.
Increasingly, Malaysia can use repeated national surveys, disease registries and age-standardised measures rather than relying on isolated crude counts.
The harder question is whether knowing has translated into change.
From Research to Better Health
There is an entire field concerned with what happens after research produces an answer.
Knowledge translation, implementation research and implementation science address related parts of that challenge: putting evidence into use and studying how to do it better.
The problem is simple:
Knowing what works does not mean that it will happen.
A useful way of looking at the research system is:
Research
↓
Evidence
↓
Policy / Guidelines
↓
Implementation in Practice
↓
Patient Outcomes
↓
Population Health
↓
New Questions
↺
Research
But the arrows are not automatic.
Good research may never influence policy. Good policy may be poorly implemented. Evidence-based guidelines may be published but not consistently followed.
And even when clinical practice changes, population health may not improve if access, affordability, adherence, behaviour or the wider environment work against it.
What happens to patients and populations should then generate the next research questions.
It is therefore better regarded as a learning cycle than a pipeline.
Interestingly, Malaysia's Health White Paper [17] returns to essentially the same challenge. Its 15-year reform framework calls for a national research strategy to strengthen the evidence base for policy and decision-making, together with attention to health-data governance, research priorities, infrastructure, human resources and funding.
The challenge is to shorten the distance between what we know and what actually happens to the patient.
Then Came COVID-19
COVID-19 provided an unexpected stress test.
Laboratory capability, epidemiology, surveillance, clinical research, data, vaccines, supply chains and rapid translation of evidence into policy suddenly became matters of national importance.
It also broadened the meaning of health research.
The Malaysia National Action Plan for Health Security 2025–2030 (MyNAPHS) [18] now emphasises surveillance and early warning, preparedness, One Health, and whole-of-government and whole-of-society approaches.
The question is no longer simply:
What infectious disease do we have?
Increasingly it is:
Can we recognise the next threat early enough to do something about it?
The Vaccine We Were Going to Make
There was another ambition in 2006 worth revisiting.
Malaysia wanted indigenous capability in vaccines and biological products.
The ambition has continued into the National Vaccine Development Roadmap, with an emphasis on strengthening local research, development and manufacturing capability. [20]
The national direction continues to emphasise domestic vaccine research, development, talent and manufacturing capability [20].
This should not simply be labelled a failure.
It illustrates how difficult the journey is from:
Research → Discovery → Clinical Development → Regulation → Technology Transfer → Manufacturing → Commercial Viability
Laboratories and trained scientists are essential. Taking a Malaysian biomedical discovery all the way to reliable large-scale manufacture also requires clinical development, regulatory capability, technology transfer and a viable market.
Vaccines therefore remain an excellent test case for the next phase of Malaysian medical research.
From Participant to Contributor
Hosting high-quality multinational research contributes to global evidence and builds Malaysian experience. The further ambition is to conceive and lead more research here.
One important development has been Malaysia’s move upstream into early-phase research. An IQVIA white paper on Malaysia’s early-phase clinical-trial ecosystem documents the Phase I Realization Project, the development of specific Phase I guidance and accreditation requirements, and two NPRA-accredited First-in-Human (FIH) sites as of 2025 — Sarawak General Hospital and Ampang Hospital. [23]
These are no longer theoretical capabilities. Sarawak General Hospital began its first FIH study in 2021 and subsequently participated in early-phase studies in oncology and autoimmune disease. Ampang Hospital became an accredited Phase I unit in 2022 and launched its first First-in-Patient study the following year. [23]
This represents a significant progression from the environment I was writing about in the late 1990s and 2006.
Malaysia was no longer participating only in the later stages of global drug development. It was beginning to move closer to where new medicines first enter clinical development.
But there is another step.
Hosting sophisticated international research — even First-in-Human research — is not quite the same as originating it.
That is where the distinction between participant and contributor becomes important.
There is now a practical example of this direction. On 1 October 2026, CRM announced a RM250,000 Research Endowment Fund to support investigator-initiated clinical research. According to its press release, the fund is open to MOH-affiliated investigators, with ICR as the coordinating body. It is intended to help studies overcome operational, regulatory, legal and publication barriers. [22]
The amount is modest. But the direction matters: supporting questions conceived and studies led by our own investigators. Whether this produces evidence that changes practice is the next test.
Research systems naturally count papers, grants, trials, investigators, GCP certificates, patents and investment. Those measures matter, but they are no longer enough.
That raises another set of questions:
How much important research is conceived in Malaysia?
How much is led by Malaysian investigators?
How much Malaysian intellectual property emerges?
How many Malaysian discoveries enter clinical development?
How many locally developed diagnostics, drugs, vaccines and medical devices reach patients?
How much research changes Malaysian clinical practice or prevents disease?
And ultimately:
Does it make Malaysians healthier?
Where Do We Go From Here?
The strategies discussed here cover different time horizons. Together, they indicate a direction for the next phase.
The Thirteenth Malaysia Plan 2026–2030 [16] calls for Malaysian health-research institutions to be strengthened as centres of excellence for clinical research in Southeast Asia, particularly in precision medicine. It also links research with innovation, talent development and commercialisation.
Meanwhile, Clinical Research Malaysia's Vision 2033 [19] sets its own targets for industry-sponsored research, including 3,500 new sponsored studies, 4,000 skilled clinical-research jobs and 80 Phase I studies by 2033.
These strategies have different purposes. Their ultimate test is the same: moving from research activity to health impact.
Twenty Years Later
Looking back at 2006, I would not describe the subsequent twenty years simply as either a success or a failure.
Malaysia did build much of the research machinery being discussed then. That is real progress.
Yet many of the problems sitting on the table in 2006 remain on the table today.
Research was never going to solve all these problems by itself. But it should help us solve them better.
The question for the next twenty years is different.
What are we doing with what we know?