Malaysia

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Fast Facts

Located in the heart of South East Asia, Malaysia boasts a large and diverse multiethnic population. It has a strong two tier health care system (recently voted number 3 worldwide) and life expectancy/infant mortality rates are comparable with the US and European countries.

  • Multiethnic population
    • Malays and indigenous (60%)
    • Chinese (28%)
    • Indian (8%)
    • Other ethnicities (4%)
  • Bahasa Malaysia is the official language; but English, Chinese and other dialects are widely used
  • Healthcare divided into private and public sectors
  • Advanced technological infrastructure
  • Strong government support of clinical research sector.

Health Trends

With its excellent medical system and improving standards of living, Malaysia is seeing a higher incidence of lifestyle diseases, along with communicable diseases in rural or disadvantaged areas.

High prevalence diseases include:

  • Heart Disease
  • Stroke
  • Influenza and Pneumonia
  • HIV/AIDS
  • Tuberculosis
  • Diabetes.

Clinical Trial Landscape

Clinical trials are regulated by the National Pharmaceutical Control Bureau (NPCB) or Medical Device Authority (MDA) and reviewed by IRBs, including the Medical Research & Ethics Committee (MREC) for trials using Ministry of Health (MOH) Malaysia facilities; or local IRBs for non-MOH facilities.

The average timeline for regulatory and IRB approval is ~3-4 months.

Market Snapshot

30  million people

72.8% reside in urban centers

95.4% literacy rate

Malaysia population age breakdown for pharma companies thinking of using a clinical research organization
  • Novotech opened its first Malaysian contract research organization (CRO) office in 2009

Why choose Malaysia for clinical research?

There are many compelling reasons to consider contract research organizations in Malaysia for your clinical research:

  • Global and regional KOLs in various specialties, such as cardiology, gastroenterology, respiratory, oncology, endocrinology
  • Streamlined regulatory system
  • Government is supportive of making Malaysia a preferred clinical research destination
  • Regulatory and Ethics submission in English, and in parallel process, with fast approval timelines
  • Quick start-up timelines as Clinical Trial Agreement and budget negotiation is straightforward
  • Lower patient costs and IRB fees compared to most countries
  • Device and non-interventional studies only require IEC approval
  • Most Investigators are GCP trained and experienced in conducting clinical trials.