05 Aug Running Clinical Trials in Asia-Pacific: A Regulatory and Cost Comparison Across Nine Markets
Asia-Pacific (APAC) has moved from being a low-cost recruitment option to a genuine strategic destination for clinical development. The region now combines large, diverse and often treatment-naïve populations, tertiary hospital networks of international standard, and — in several markets — regulatory data that the FDA and EMA are prepared to accept. For sponsors planning a global program, the question is no longer whether to include APAC, but which APAC markets to include, at which phase, and why.
At Derodes Partners, we help sponsors answer exactly that. This article maps nine Asia-Pacific markets — China, India, South Korea, Australia, Japan, Malaysia, Thailand, Singapore and Vietnam — against four decision criteria that matter most in practice: core strength, regulatory start-up speed, cost relative to the United States, and the structural limit that caps what each market can realistically deliver. It also makes the case for a strategy we increasingly recommend: designing global, multi-regional trials from the early phase, so that the data generated in Asia are usable for eventual FDA and EMA submission rather than merely supportive.
Why think globally and early ?
The historical model treated Asia as a place to add Phase II/III recruitment volume once a molecule was already well characterised in the West. That model leaves value on the table. Under the ICH E17 framework on multi-regional clinical trials (MRCTs), a single, well-designed study can enrol patients across several regions simultaneously, generate data across different ethnic and genetic populations, and support marketing applications in multiple jurisdictions at once. The FDA and EMA both accept foreign and multi-regional clinical data provided the trials are conducted to ICH-GCP standards and the study is designed with regulatory acceptability in mind from the outset (in the US, this is codified in 21 CFR 312.120 for studies conducted outside an IND).
The strategic implication is significant. If a sponsor waits until late-phase to introduce Asian sites, it may face questions about intrinsic and extrinsic ethnic factors — how the drug behaves in populations that were absent from the pivotal early data. By building diverse populations into first-in-human and early-phase work, sponsors generate that evidence upfront. Bridging studies shrink or disappear, dossiers become more robust, and a future filing in the US, Europe and key Asian markets rests on one coherent evidence base. Early-phase globalisation is not a cost exercise; it is a de-risking exercise for the eventual market authorisation.
The catch is that APAC is not one market. Regulatory maturity, data quality, cost and speed vary enormously across the region, and the countries that are best for regulatory-grade early-phase data are rarely the same as those best for high-volume, low-cost recruitment. Choosing well means matching each market to the job it does best.
The established five: North & East and Pacific
The region’s mature markets offer the deepest track record and, in several cases, data that Western regulators already trust.
China is unmatched for enrolment scale, offering vast, often treatment-naïve patient pools at the lowest cost in the region. The NMPA cut review timelines by roughly 30% in 2025, making start-up genuinely fast. The trade-off is geopolitical and data-governance exposure, legislation such as the proposed BIOSECURE Act and tightening data-transfer rules, and the reality that China-only datasets can attract FDA scrutiny. China is powerful within a global design, less so as a standalone data source.
India offers a large, diverse population at the region’s lowest cost (roughly 30–50% below US levels), with an early-phase ecosystem that is steadily maturing and a new prior-intimation pathway expected from 2026. Sponsors should plan around enrolment variability, still-thin Phase I capacity, and data-localisation requirements under the DPDP Act.
South Korea is a different proposition: top-tier data quality that is readily accepted by the FDA and EMA, with genuine depth in oncology. MFDS reviews an IND in around 30 working days and IRB clearance runs about three weeks. Costs are moderate, higher than India, and the population (51.7 million) and site congestion cap the volume any single program can capture.
Australia is the region’s classic early-phase entry point. Its notification-only start-up lets a first-in-human study reach first patient in around three months, ethics review takes four to eight weeks, and its Western-like population makes the data highly translatable. The R&D tax rebate brings effective costs to roughly 60% below the US (about 28% lower before the rebate). The limits are a small population (~26 million) and the requirement for a local sponsor, Australia is a speed-and-quality play, not a volume play.
Japan brings innovation strength and remains effectively required for a Japanese label, with useful orphan-drug flexibility. Post-2023 reforms have accelerated Japanese Phase I work, though the process remains deliberate and costs are the highest in the region. The much-discussed “drug loss” phenomenon, only about 4% of new global trials are Japan-led, underlines why early inclusion matters for sponsors who want the Japanese market.
The emerging four: Southeast Asia
Southeast Asia is where much of the region’s recent momentum sits, spanning a genuine premium hub through to high-potential frontier markets.
Singapore is the standout for regulatory-grade early-phase work: world-class data quality accepted by the FDA and EMA, a premier first-in-human and biotech ecosystem, and the fastest, most predictable timelines in APAC (HSA CTN clearance in about five working days, CTA around 30, with a single-IRB mutual-recognition arrangement since April 2025). The trade-off is cost, near US and EU levels, and a very small population (~5.9 million), making it an anchor and early-phase site rather than a recruitment engine.
Malaysia offers a multi-ethnic, genetically diverse and English-speaking environment, with Clinical Research Malaysia acting as a single-point facilitator that can compress contracting to roughly five working days. NPRA approval runs about 30 working days (MREC ethics around 50), and costs sit some 40–60% below Singapore, Japan and Korea. The population (~34 million) is modest and early-phase capacity, concentrated in the Klang Valley, is still developing.
Thailand provides a large pool (~71 million) with universal health coverage, strong tertiary hospitals and real depth in infectious disease and oncology, well suited to Phase II/III recruitment. Thai FDA review takes 30–60 days and a realistic first-patient timeline is three to five months. Costs run 30–40% below the US. Sponsors should note there is no single CTA route, PDPA data rules apply, and early-phase capacity is thin.
Vietnam is the region’s frontier opportunity: a very large, young pool (~100 million), a high infectious-disease and oncology burden, low competing-trial density and strong government backing (Resolution 57). The trade-off is timelines and maturity, DAV review of three to five months, first patient in six to nine months, roughly 40 GCP-ready sites, minimal early-phase infrastructure, Vietnamese-language documentation and new PDPL data rules in 2026. The upside is real for sponsors who plan the timelines in.
At a glance: the nine markets
The comparison below summarises each market on the four decision criteria. Figures are 2025–2026 planning estimates and should be treated as directional.
wd = working days · FP = first patient · pop. = population. Country-specific cost-vs-US percentages are rarely published; ranges reflect an APAC-wide benchmark.
Matching the market to the job
A few practical patterns emerge from this comparison. When the priority is volume and speed at the lowest cost, China and India lead on enrolment scale, with Vietnam adding an enormous treatment-naïve pool once its timelines are planned for. When the priority is regulatory-grade data and early-phase quality, Singapore and South Korea deliver FDA/EMA-accepted evidence, with Singapore the fastest and most predictable first-in-human hub. For Phase II/III recruitment across Southeast Asia, Thailand and Malaysia pair diverse populations with reasonable cost — and Malaysia’s single-point facilitation is a genuine timeline advantage.
Throughout, the structural limits deserve as much attention as the strengths: small populations in Singapore, Australia and Korea; slow or opaque approvals in Vietnam and, to a degree, Japan; and data-protection regimes tightening across almost every market. These are not reasons to avoid APAC — they are reasons to design the footprint deliberately.
The Derodes Partners view
The most effective APAC strategy is rarely a single country; it is a portfolio. A well-constructed global trial might anchor early-phase, regulatory-grade work in Singapore or Australia, layer in South Korea for high-quality oncology data, and scale recruitment through China, Thailand or Vietnam, all within one ICH E17-aligned design built for FDA and EMA acceptability from first-in-human onward. Done well, this generates diverse population data early, strengthens the eventual dossier, and shortens the path to approval across multiple regions at once.
The figures cited here are 2025–2026 planning estimates and should be treated as directional rather than contractual; country-specific cost-versus-US percentages are rarely published, so the ranges reflect an APAC-wide benchmark. What does not change is the underlying logic: Asia-Pacific offers a rare combination of scale, diversity, quality and speed, and the sponsors who capture it are the ones who plan globally and start early.
To discuss how a multi-regional APAC strategy could fit your development program, contact the Derodes Partners team.
Sources & references
Country-level figures (cost, start-up timelines, population) are compiled from the sources below; regulatory references support the multi-regional trial and FDA/EMA acceptability framework. Figures are 2025–2026 planning estimates and should be treated as directional rather than contractual; country-specific cost-versus-US percentages are rarely published, so ranges reflect an APAC-wide benchmark.
Malaysia — Applied Clinical Trials (Malaysia's clinical research ecosystem); NPRA — approved clinical trial import licence (npra.gov.my); Clinical Research Malaysia (clinicalresearch.my); Kitsa — geography of clinical trials: Malaysia.
Thailand — Novotech — Thailand country profile; Credevo — APAC start-up guide 2026 & Thailand challenges; ClinRegs / NIAID — Thailand.
Singapore — HSA — apply CTA / CTN (hsa.gov.sg); Precision for Medicine — Singapore clinical trials; Credevo — APAC start-up guide 2026.
Vietnam — Credevo — Vietnam for clinical trials in 2026; OUCRU — roadmap to the future of clinical trials in Vietnam; Kitsa — geography of clinical trials: Vietnam; Tilleke & Gibbins / ITIF — Vietnam PDPL & data transfer.
Cross-market (China, India, South Korea, Australia, Japan) — Clinical Leader — why APAC clinical trials cost less.
Regulatory framework — ICH E17 — General Principles for Planning and Design of Multi-Regional Clinical Trials (ich.org; federalregister.gov); FDA — 21 CFR 312.120, Foreign clinical studies not conducted under an IND (ecfr.gov); FDA — Guidance on Acceptance of Foreign Clinical Studies (fda.gov).
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