Clinical_trials_Malaysia_Credevo

Malaysia is among some of the world’s most popular countries for coastal tourism, known for culinary sensations, beautiful beaches, idyllic islands and national parks. But, do you know that Malaysia has a strong health care system and can be a preferred country for your clinical trials?

Clinical_trials_Malaysia_Credevo

Yes, Malaysia boasts a large and diverse multi ethnic population, strong two tier health care system and life expectancy/infant mortality rates that are comparable to the US and European countries.

Why consider Malaysia?

There are many compelling reasons to consider

  • Competitive costs and an established healthcare system
  • Various specialties, such as Cardiology, Gastroenterology, Respiratory, Oncology, Endocrinology
  • Government supportive of making Malaysia a preferred clinical research destination
  • Streamlined regulatory system
  • Regulatory and ethics submission in english and is a parallel approval process, with fast approval timelines
  • Quick start-up timelines as clinical trial agreement
  • 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
  • Launch of Phase 1 Clinical Trial Guidelines that had enabled Malaysia to conduct early phase trials on drug discovery and development. [5]

Landscape of Malaysia

  • 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

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 with the objectives of effectively increasing the speed, reliability and delivery of outcomes.

The current Malaysian Economic Transformation Program (ETP) targets clinical research as one of its main drivers in economic growth.

Therapeutic lineup

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

Total clinical trials conducted in malaysia according to clinicatrials.gov are 1,223 with 322 On-going studies. [Data as on 15-Oct-2019]

Currently, the major therapeutic areas for clinical trials are

  • Heart disease and Stroke
  • Influenza and Pneumonia
  • HIV/AIDS
  • Tuberculosis
  • Diabetes. [1][2]

Recent achievements

  • Clinical trials of new Hepatitis C combination treatment held in the country, has shown not only a high 97% cure rate but also better efficacy of treating the most severe form of Hepatitis.
  • Hospital Miri, Sarawak for being the 2nd Top Recruiter Globally for a respiratory study recently. The study team is lead by principal investigator, Dr. Desmond Samuel.
  • Hospital Kuala Lumpur was among the top 2 recruiter for a Cancer Registry study in Asia.
  • Government signed MoU’s with CRO’s to attract more global trials into the country. [5]

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Regulatory

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 National Pharmaceutical Regulatory Agency (NPRA) ensures the quality, efficacy and safety of pharmaceuticals in Malaysia.
  • The NPRA acts as a Secretariat to the Drug Control Authority (DCA)
  • The DCA is empowered to review matters related to product registration and approve or reject application for clinical trial import license (CTIL) or clinical trial exemption (CTX).

Clinical Trial Import Licence (CTIL): A clinical trial import licence is issued to import any product for purposes of clinical trials.

Clinical Trial Exemption (CTX): Authorization to manufacture any product/s solely for the purpose of producing samples for clinical trials. [3][6]

Locations and sites

  • Clinical trials in Malaysia can be conducted in ministry establishments, private hospitals and medical teaching hospitals.
  • There are well established medical centres and site in malaysia which are ranked top in conducting and recruiting clinical trials.

Ethics Committee

The Institutional Review Board (IRB) structure in Malaysia depends on the location or type of facility conducting the research.

  • Most university hospitals have their own local IRB/IEC, while research conducted at ministry of health hospitals fall under the purview of the central IRB,
  • There are 13 IRBs/IECs in Malaysia registered with the NPCB, which include the Ministry of Health Medical Research and Ethics Committee (MOH MREC), the Penang Ethics Committee and ethics committees from universities and private hospitals.
  • Clinical trials conducted at these sites have to be approved by the respective IRB/IEC.
  • The MOH hospital sites have only one central IRB that is the MOH MREC.
  • Applications can be submitted online via the National Medical Research Register.

Fee for the EC review

  • At present there no fee required for EC review.
  • The processing fee per product is RM500. [3]

Registration of Clinical Trial

  • All the clinical trials that require CTIL/CTX must be registered with National Medical Research Register (NMRR).
  • Before submitting CTIL/ CTX application to NPCB, the applicant should obtain a unique full NMRR Registration Number from NMRR website.
  • Applicant is required to quote the NMRR Registration Number in all communication with National Pharmaceutical Control Bureau (NPCB).

Who can apply for CTIL/CTX ?

  • An investigator,
  • An authorised person from a locally registered pharmaceutical company/ sponsor/CRO with a permanent address in Malaysia,
  • A sponsor or CRO without an office in Malaysia can outsource service to any of the local/international CROs or SMO. [4]

What is the type of approval ?

CTIL/CTX and MREC applications can be submitted in parallel

Approval process

  • CTIL/CTX applications are submitted to the NPRA following the guidelines for CTIL/CTX.
  • The NPRA screens the application dossier for completeness before handing them over to the DCA for a decision to be made.
  • PI/CRO/sponsor who intend to submit to MREC are required to register with the National Medical Research Register (NMRR) website and obtain a user account used for all submissions thereafter.
  • CTIL/CTX application is processed within 30 working days, while the MREC approval takes 50 working days (if no amendments to the submitted documents are required).
  • Both CTIL/CTX and MREC applications can be submitted in parallel.
  • Once approval is granted by both the DCA and MREC (or other accepted IRB/IEC), the NPRA issues the CTIL/CTX and regulatory approval letters to begin the clinical trial. [3] [4]
NPCB: National Pharmaceutical Control Bureau, CTIL: Clinical trial import license, CTX: clinical trial exemption, DCA: Drug Control Authority, CINP: Centre for Investigational New Product

Timeline for approval

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

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References

  1. http://www.novotech-cro.com/locations/malaysia
  2. https://clinicaltrials.gov/ct2/resultscond=&term=&cntry=MY&state=&city=&dist=
  3. http://www.appliedclinicaltrialsonline.com/malaysia-s-clinical-research-ecosystem?pageID=3
  4. http://www.crc.gov.my/faq/
  5. http://www.clinicalresearch.my/malaysia-to-generate-healthcare-revenue-rm2-8b-by-2020/

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