A routing decision based on expert analysis of risk, timeline and cost, for the United States, the United Kingdom, the main European Union countries, China and Australia.
Choosing the location is the first step. Bidding and oversight are optional, and the client decides at each step.
VeloArc works only for the client. It is paid by the client, never by the vendors, so its only interest is the best outcome for the client's study.
Cell and gene therapy: a company Phase 1 under a Chinese investigational new drug approval follows the normal drug route. Hospital led studies of new cell and gene technologies fall under State Council Order 818, in force since 1 May 2026, which limits them to tertiary Grade A hospitals.
| United States, Food and Drug Administration | To support the next study: yes, if the study followed good clinical practice and the agency can check the data, including by inspecting the sites (21 CFR 312.120). To approve the drug: results from China alone are rarely enough, because they must clearly apply to US patients (21 CFR 314.106). That is why later studies add US or other Western sites. |
|---|---|
| European Union, European Medicines Agency | Accepts studies run outside the Union if they met standards equivalent to EU good clinical practice. May ask for bridging data where ethnic differences could change the result (ICH E5). |
| United Kingdom, Medicines and Healthcare products Regulatory Agency | Accepts international data on the same principles. Its International Recognition Procedure, which relies on other regulators' approvals, does not list China's regulator as a reference regulator, so a Chinese approval does not shorten the UK review. |
The toxicology package, not the country, is the main cost lever. Every regulatory clock above is 0 to 60 working days. A full investigational new drug enabling toxicology package for a small molecule costs about 1.5 to 3.5 million dollars and takes 12 to 18 months, with the 28 day dog study alone 5 to 7 months on the critical path (vendor tier figures). Where you file changes the clock by months. What toxicology you run changes it by years.
The route to examine first is ICH M3(R2) Approach 5: a 14 day therapeutic range first in human study on a rodent package, plus a confirmatory non rodent study of at least 3 days at the rodent no observed adverse effect level. It is accepted by the Food and Drug Administration, the European Medicines Agency and the Australian Therapeutic Goods Administration. The United Kingdom position is inferred only. It reorders spend and kills weak candidates early; it does not remove the full package for a candidate that survives. Approaches 1 and 2, the microdose routes, cap total dose at 100 and 500 micrograms and cannot answer a therapeutic range question.
The rules on this page come from the regulators' own texts, including: the US Code of Federal Regulations on foreign clinical data (21 CFR 312.120 and 314.106); the European Union Clinical Trials Regulation (536/2014); Australia's Therapeutic Goods Act and Clinical Trial Notification guidance; China's National Medical Products Administration notice [2025] No. 86 and State Council Order 818; and the international guidelines ICH M3(R2) and ICH E5. The only published country cost comparison is Frost and Sullivan, 2016, used here for relative order only.
The numbers marked Example are not real. They are illustrative only, for now. Real numbers like these are not publicly available, and VeloArc is collecting them.
Every answer is checked by an expert. In a client report, the recommendation, the numbers and the risks are reviewed and signed off by an expert who has run studies in that location, before the report reaches the client.
Two things produce that data, and only those two.