Malaysia’s clinical trials industry body Clinical Research Malaysia (CRM) has launched the country’s first Phase I Clinical Trial Guidelines. The new guidelines present a standardised reference for First In Human (FIH) trials undertaken in Malaysia [1].
The launch of the Phase I guidelines is part of the Malaysian government’s wider Phase I Realisation Project (P1RP); an initiative aimed at establishing and growing an early phase research industry in Malaysia.
The guidelines were based on the Association of British Pharmaceutical Industry Guidelines and developed following consultation with several Malaysian and regional key opinion leaders.
In launching the new guidelines, Malaysian Health Minister Dr Subramaniam said, “The current Malaysian Economic Transformation Program (ETP) targets clinical research as one of its main drivers in economic growth. In line with this, the Ministry of Health is focusing on streamlining the processes, expanding its experience, facilities and training in the conduct of Phase I clinical studies.” [2]
“Like many countries within the region, Malaysia is keen to engage with the increasing levels of interest from international sponsors in accessing the untapped clinical trial benefits of Asia,” said Novotech Executive Director of Asia Operations Dr Yooni Kim, “Within Asia, while Malaysia has one of the lowest levels of clinical trial density and levels of per capita government healthcare expenditure; it is also ranked globally within the Top 30 for intellectual property right protection [3]. Together with the Malaysian government’s commitment to growing its domestic clinical trials industry, these elements are most definitely increasing Malaysia’s attractiveness as a global clinical trial destination for early stage research.”
The new CRM Phase I Clinical Trial Guidelines are available online
For more information about the untapped clinical trial benefits available in Malaysia, download a free copy of the Frost & Sullivan white papers, ‘Asia: Preferred Destination for Clinical Trials’ or feel free to contact us.
About Novotech - www.novotech-cro.com
Headquartered in Sydney, Novotech is internationally recognised as the leading regional full-service contract research organisation (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I - IV clinical trials in the Asia Pacific region. Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence included running clinical trials in all key regional markets. Novotech also has worldwide reach through the company's network of strategic partners.
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[3] Frost & Sullivan, Asia: Preferred Destination for Clinical Trials; 2016