Malaysia Increasing it’s Capabilities in Early Phase Clinical Research

Kuala Lumpur, 26 July 2023 – Clinical Research Malaysia (CRM) inked an education scholarship agreement with the Ministry of Health (MOH) and National Pharmaceutical Regulatory Agency (NPRA) earlier today at CRM headquarters. Under the agreement, CRM will be sponsoring two NPRA officers to pursue their Master’s program in Clinical Pharmacology at King’s College London.

The initiative is aligned with CRM’s Phase 1 Realisation Project (P1RP) 2.0, which focuses on further enhancing Malaysia’s capabilities on early phase/first-in-human trials. The project is an extension of the initial P1RP program launched in 2016 in which three NPRA officers and a Medical Oncologist from Sarawak General Hospital were sponsored for postgraduate studies and fellowship attachment respectively, at renowned global institutions, to build their expertise in early phase trials. Investment in human capital development is a continuous effort taken by CRM, an organization wholly-owned by the MOH, to ensure the country’s readiness for safe and high-quality conduct of clinical trials.

Representing the organisations at the signing ceremony were Deputy Secretary-General Finance of MOH, Dato’ Sri Norazman Ayob, Chief Executive Officer of CRM, Dr. Akhmal Yusof as well as NPRA officers Siti Norhayani Ismail and Fatin Diyana Fauzi. The sponsorship agreement was witnessed by YB Dr. Zaliha Mustafa, the Minister of Health and Rosilawati Ahmad, NPRA Director.

During the same program, YB Dr Zaliha also launched the Malaysia Decentralised Clinical Trial (DCT) Guidance Document. This guidance document is a first in Malaysia and will be an important step in aligning to the global trends of clinical trials where patient-centricity becomes more important, as well as adopting new and innovative clinical trial designs. The document was developed by clinical research stakeholders within the country and endorsed by the National Committee for Clinical Research.