马来西亚：早期阶段试验的新目的地

Malaysia: The New Destinationfor Early Phase Trials MARLOWE SAULON IMPERIAL, Senior Medical Director, IQVIA APACLYDIA PAUL,Full-Service Operations Head, IQVIA MalaysiaTAN LI LING,Oncology/Hematology, Associate Medical Director, IQVIA Malaysia Table of contents Introduction1Malaysia’s unique value proposition in early clinical development2Clinical trial ecosystem and accredited sites2Population heterogeneity5Quality10Speed11Patient access12Malaysia’s expanding footprint in early-phase clinical trials13Conclusion14Disclosure14Acknowledgement15References16About the authors19 Introduction Early clinical development, encompassing phase Iand phase II clinical trials, is a pivotal stage in thedrug development continuum. These trials involve theinaugural testing of investigational drugs in humansto evaluate safety, tolerability, pharmacokinetics,pharmacodynamic and preliminary efficacy. Theoverarching objective of early clinical developmentis to amass essential data supporting thedrug’s advancement to subsequent phases ofclinical evaluation. destinations with untapped potential. Malaysia, locatedin Southeast Asia, is rapidly gaining recognition asa promising hub for early-phase clinical research,particularly FIH studies. With a history of hostinginternational trials, Malaysia has steadily built areputation for quality and reliability. Its healthcaresystem features accredited hospitals, GCP-compliantinfrastructure, and a genetically diverse population,making it an ideal setting for FIH studies. Importantly, Malaysia’s government has demonstratedstrong commitment to advancing clinical research.Through initiatives led by Clinical Research Malaysia(CRM) and support from the Ministry of Health,the country has streamlined regulatory processes,invested in scientific infrastructure, and fosteredpublic-private partnerships to attract global sponsors. First-in-Human (FIH) clinical trials serve as thefoundational phase in clinical drug testing,transitioning investigational products from preclinicalevaluation to human subjects. In scenarios wheredose-selection, population characteristics, studydesign, safety monitoring, and expertise rely solelyon preclinical data, ensuring subject safety and dataquality becomes paramount. The selection of triallocations significantly influences subject safety,data quality and the generalizability of findings tobroader populations. This white paper delineates Malaysia’s infrastructural,demographic and regulatory strengths in hosting FIHtrials. It highlights the nation’s scientific readiness,ethnogenetic diversity and compliance withinternational standards. Positioned within the GlobalSouth, Malaysia provides valuable data and insightsinto underrepresented populations, enhancing thegeneralizability and equity of global therapeuticdevelopment. By showcasing Malaysia’s valueproposition, this paper aims to support sponsors inmaking informed decisions about trial placement andstrategic expansion. Globally, sponsors are increasingly turning to Asia forearly-phase trials, drawn by the region’s large patientpopulations, modern clinical infrastructure, skilledworkforce, and cost efficiencies. However, traditionalhubs in Asia are experiencing saturation, leading tolonger trial timelines and operational bottlenecks.This shift has prompted sponsors to explore emerging The government of Malaysia had initiated Phase IRealization Project (P1RP) to move Malaysia’s focusfurther upstream to early phase drug discovery anddevelopment. Through P1RP, the comprehensive PhaseI Clinical Trial Guidelines was released in 2017. Thisguideline was developed based on the Association ofBritish Pharmaceutical Industry (ABPI) guidelines forthe conduct of Phase I trials. In addition, internationalexperts on clinical trials were also invited as Subjectmatter experts and to be part of the steeringcommittee. As of 2025, these guidelines continueto serve as the national reference standard for theconduct of phase I and FIH trials in Malaysia. Theyare complemented by related regulatory documentssuch as the Malaysian guideline for phase I unitinspection and accreditation program by NPRA. To beable to conduct FIH studies, sites in Malaysia must byaccredited by Malaysia’s regulatory authority NationalPharmaceutical Regulatory Agency (NPRA). As of 2025,there are two accredited sites for FIH studies, SarawakGeneral Hospital and Ampang Hospital. Malaysia’s uniquevalue proposition in earlyclinical development Clinical trial ecosystem andaccredited sites Malaysia has strategically nurtured a favorableenvironment for early-phase research. Theestablishment of Clinical Research Malaysia (CRM)in 2012 as a national one-stop center and sitemanagement organization for the Ministry of Healthfacilities has significantly streamlined sponsorengagement and site activation process. CRM is anon-profit entity wholly owned by the Ministry ofHealth. It facilitates the needs of industry stakeholders,expands the pool of qualified investigators an