Navigating Clinical Trials in the Philippines and Malaysia: Insights and Opportunities

Due to a combination of large, diverse populations, effective healthcare infrastructure, and evolving regulatory and legislative changes, the Philippines and Malaysia have become favoured destinations for sponsors looking to conduct clinical research.?

In this blog, we’ll explore the clinical trial landscapes of these two nations, looking at their distinct advantages, regulatory frameworks, and the opportunities they present for advancing global medical research.?

By examining key factors such as patient recruitment capabilities, cost-effectiveness, and quality standards, you’ll learn key insights for sponsors considering these markets.?

The Philippine Clinical Trial Landscape

With a population of approximately 113 million, the Philippines is the 12th most populous country in the world. The region’s unique combination of a large population, efficient regulatory processes, and cost-effective research opportunities positions it as an optimal environment for clinical trial development.?

Key insights:?

• Top causes of mortality include ischemic heart disease, malignant neoplasms, cardiovascular diseases, pneumonia, and diabetes mellitus.
• Clinical trial infrastructure:

Regulatory Framework and Timelines

The Philippine Food and Drug Administration (FDA) is the primary regulatory body overseeing clinical trials in the country.?

Approval from the Philippine FDA is mandatory for all clinical trial applications and import licenses, with concurrent requirements for local Institutional Review Board (IRB) approval.

Key documents for reference include:

• Philippine FDA Administrative Order No. 2020-0010: Regulations on the Conduct of Clinical Trials for Investigational Products
• National Ethical Guidelines for Health and Health-Related Research (2022)

The Philippine's regulatory framework is designed to be simple yet compliant with worldwide regulations.

Review timelines are typically:

• Local Ethics Committee/IRB approval: 2-4 months
• Philippine FDA approval: 2-3 months
• Overall startup activities (from submission to site initiation): 4-5 months

Why Choose the Philippines for Clinical Trials

1. Rapid Enrollment

The Philippines excels in patient recruitment due to its large, diverse population and numerous clinical trial sites.?

Notably, a COVID-19 vaccine trial achieved 9,000 enrolled subjects in just two months. Similarly, 1,000 subjects were recruited in a month for a schizophrenia study. This rapid enrollment capability is particularly strong in late-phase trials (Phase III and IV).

2. Cost-Effectiveness

Running trials in the Philippines can mean significant cost advantages.?

Trial expenses can be approximately 60% lower than those of the US and 20-30% lower than those of Western European countries. The average cost per patient for a Phase III trial falls between $1,800 and $2,500 for investigator site fees.1

3. Quality of Trials

The Philippines maintains high standards in clinical trial conduct, which have been validated by international regulatory authorities. Inspections by the US FDA, Japanese PMDA, and Chinese regulatory authorities have not resulted in any warning letters.

Recent Updates and Upcoming Regulatory Changes in the Philippines

The Philippines is on the verge of introducing new legislation that holds the potential to significantly enhance its clinical trial sector.?

The pending Clinical Trial Innovation Act aims to accelerate the discovery and development of innovative medicines. The Act provides tax incentives for sponsors and CROs, prioritizes the processing for new drug applications. The legislation also includes provisions for managed entry agreements to the Philippine National Drug Formulary.?

In addition to this potential new legislation, the Philippines has already taken steps to streamline its regulatory processes with the Regulatory Reliance Guideline (2023). These guidelines aim to reduce the conduct of clinical trial approval timelines to 20 working days for eligible studies.

The Malaysian Clinical Trial Landscape

Malaysia offers a blend of advanced healthcare infrastructure, strategic location, and a diverse population. This Southeast Asian nation presents unique opportunities for sponsors looking to conduct clinical trials in the region.

Key insights:?

• Multi-racial population of approximately 34 million
• Leading causes of death: Ischemic heart disease, pneumonia, cardiovascular disease, and cancers
• High literacy rate with widespread English fluency
• Universal healthcare system with a strong network of hospitals and medical centers

Regulatory Bodies and Regulatory Processes

Malaysia has several key stakeholders overseeing clinical trials:

The Ministry of Health (MOH) oversees several key bodies involved in clinical trials and is the highest authority.?

The National Pharmaceutical Regulatory Agency (NPRA) reviews all clinical trial applications, ensuring they meet the necessary safety and ethical standards. Clinical Research Malaysia (CRM), established in 2012, plays a crucial role in fostering a robust clinical research environment. For trials involving medical devices, the Medical Device Authority provides specialized oversight.?

The regulatory process in Malaysia is efficient and aligned with international standards:

• Start-up activities 4-5 months (from preparation to approval)?
• Clinical Trial Import License (CTIL) application approval in 8-12 weeks

Additional applications include:

• BLESS (Business Licensing Electronic Support System) application for sample exportation (a few days to complete)
• SIRIM (Standards and Industrial Research Institute of Malaysia) application for importing medical devices (a few days to complete)
• Only patient-facing documents need translation into Malay; English is sufficient for other documents

Advantages of Conducting Trials in Malaysia

1. Strategic Location

Malaysia's geographic position offers several strategic advantages for conducting clinical trials. Situated at the heart of Southeast Asia, it serves as a gateway to neighboring countries, facilitating multi-regional studies and providing access to a broader patient base.?

This strategic location has become even more significant with Malaysia's inclusion in China's Belt and Road Initiative, making it an attractive destination for Chinese pharmaceutical companies looking to expand their research activities internationally.

2. Quality and Reputation

Malaysia has maintained a track record with no FDA Form 483 or equivalent warning letters issued to date.? As of 2023, Malaysia has 250 qualified sites capable of conducting clinical trials, all of which adhere to procedures compliant with ICH GCP guidelines. Sponsors and regulatory bodies can initiate QC and QA visits.

3. Diverse Population

The country's multi-ethnic demographic provides a rich pool for clinical research, offering opportunities for studies that can provide insights into different genetic and environmental factors affecting health.?

Malaysia is actively working to enhance its position in the clinical research landscape. The launch of Phase I Clinical Trial Guidelines in 2017 by CRM marks a significant step towards establishing and growing early-phase research in the country. There's also an increasing focus on cutting-edge areas such as personalized medicine, genomics, and regenerative medicine.?

Global Reach and Sponsorship

In the Philippines, the distribution of trial sponsors shows a strong international presence:

• Approximately 70% of trials are sponsored by pharmaceutical companies from the US and Europe.
• The remaining 30% consists of a mixture of Asian organizations, including sponsors from South Korea, Japan, Mainland China, and Taiwan.

Malaysia presents a similar yet evolving picture. Historically, the majority of clinical trials in Malaysia were sponsored by large pharmaceutical companies from the US and Europe. However, recent years have seen a shift in this pattern:

• 70-80% of trials were previously conducted by big pharma from the US and Europe, often as part of global multi-center studies.
• There's been a noticeable increase in sponsors from Asian countries, particularly China, Japan, and South Korea.
• The proportion of Asian sponsors, especially from China, has grown to approximately 20-30% of total trials.

This changing landscape in Malaysia is partly attributed to the deepening of the Belt and Road Initiative, which has encouraged Chinese biomedical companies to expand their research activities into Southeast Asian countries.

Opportunities and HiRO’s Global Reach

Both the Philippines and Malaysia are experiencing new developments that are reshaping their future in clinical research. However, having the right support within these regions is key for trial success.?

HiRO offers comprehensive global reach and expert support to sponsors looking to leverage the opportunities these regions present.?

As a trusted CRO addressing unmet R&D needs through customized solutions, HiRO operates across the US, Europe, and the Asia-Pacific region, with dedicated local teams ensuring tailored support.. Our multinational team is adept at providing strategic guidance and operational support customized to the distinctive regulatory and cultural environments of each country..

Importantly, HiRO upholds the highest global standards of compliance and data protection. We have successfully passed eight audits and over 20 qualification audits from customers and partners since 2020.?

By partnering with experienced CROs like HiRO, sponsors can navigate the complexities of these emerging markets and tap into the wealth of opportunities they present for advancing medical research and improving global health.

References:

[1] Frost and Sullivan White Paper on Asia: Preferred Destination for Clinical Trials (2016)