TL;DR:
Yes. FDA has an established regulatory pathway for accepting clinical data generated outside the United States, including studies that were not conducted under a US IND.
Under 21 CFR 312.120, FDA can accept a well-designed and well-conducted foreign clinical study not conducted under an IND as support for a future IND or marketing application.
The study must follow good clinical practice, including independent ethics committee review and documented informed consent. FDA must also be able to validate the data through an onsite inspection if the agency considers one necessary.
FDA reinforced this position in September 2026, they stated that the data must be “reliable, inspectable, and ethically derived”.
FDA does not regulate European clinical trials. A trial conducted in the European Union is governed by the EU Clinical Trials Regulation and is submitted, reviewed, and managed throughout its regulatory lifecycle through the Clinical Trials Information System, or CTIS.
FDA becomes relevant when the sponsor intends to use the European data as part of a US regulatory submission. This does not mean sponsors need to develop two completely separate clinical programs for Europe and the United States.
The two systems share an important foundation: the International Council for Harmonisation guideline for Good Clinical Practice, or ICH GCP. It provides an international framework for the design, conduct, documentation and reporting of clinical trials and was developed in part to facilitate the mutual acceptance of clinical data across regulatory regions.
This common framework is what makes international clinical development possible in practice because a clinical trial run in the EU shares many of the principles expected by FDA.
However, CTIS authorization does not itself guarantee that FDA will consider the resulting data sufficient for every US development decision.
Depending on the product and development stage, FDA may have additional expectations concerning the study design, endpoints, dose selection, patient population, nonclinical evidence or manufacturing. The important step is to identify any FDA-specific requirements early and incorporate them into the development plan.
No. A US IND is not required simply because a US company chooses to conduct its clinical trial in Europe.
For running a clinical trial in the United States, a sponsor must have an ethics committee approval and IND in place before beginning a clinical investigation.
This gives early-stage companies flexibility in deciding where to generate their first clinical evidence while preserving the possibility of subsequent US development.
FDA requires sponsors to submit a specific supporting information package when relying on a foreign study that was not conducted under an IND. FDA also recommends that sponsors clearly identify where the information required under 21 CFR 312.120 appears within the submission.
| Requirement | What FDA expects |
|---|---|
| Investigator qualifications | Documented credentials for every investigator involved |
| Research facility description | A description of the facilities where the study was conducted |
| Protocol and results summary | Information detailed enough for FDA to assess the study and its results |
| Drug product description | Components, formulation, specifications and available bioavailability information |
| Ethics committee documentation | The committee's name, address and confirmation that it meets FDA's definition of an independent ethics committee |
| Informed consent process | A description of how informed consent was obtained from participants |
| Monitoring and GCP training | Evidence of how the study was monitored and how investigators were trained on GCP and the protocol |
None of these requirements means that a sponsor needs to duplicate the European trial in the United States. In fact, many of these requirements are asked CTIS itself.
Rather, they mean that a Europe-first study intended for later FDA use should be conducted and documented with that future use in mind.
The sponsor should also be able to demonstrate that documented procedures were followed in practice. This includes oversight of investigators, protocol compliance, data quality and systems used to protect participants.
International patient populations are a normal part of global clinical development. Large Phase III programs routinely generate evidence across multiple countries and regions.
When European data are intended to support US development or commercialization, the sponsor should consider whether the study population is relevant to the patients who will ultimately receive the product in the United States.
This can be particularly relevant when a program is conducted predominantly within one ethnic or geographic population. Depending on the product, disease and development program, sponsors may need US sites or a broader international site strategy to ensure that clinically relevant demographic groups are represented.
A sponsor does not need an approved or submitted IND to request FDA feedback on its development plan.
This creates an important opportunity for companies following a Europe-first strategy: sponsors can obtain FDA input on their future US pathway without first moving the clinical trial to the United States.
FDA states that sponsors may obtain advice from the agency before formal submission of an IND and may send a pre-IND meeting request to the review division responsible for the relevant therapeutic area. A pre-IND interaction can cover the nonclinical program, the design of the proposed clinical trial, the data needed to support the IND, and other parts of the development strategy. FDA does not charge a fee for these meetings.
For products reviewed by FDA’s Office of Therapeutic Products (OTP), which includes cellular and gene therapy products, OTP generally grants one pre-IND meeting per product and clinical indication. That restriction should not be assumed to be an FDA-wide rule for every therapeutic product.
When the United States is an important future market, we recommend seeking FDA feedback before starting the European clinical trial whenever possible. This gives the sponsor an opportunity to identify any US-specific considerations while the European program can still accommodate them efficiently.
If the European trial has already started, a pre-IND meeting can still help the sponsor understand how FDA views the available data and what additional evidence may be required. A Europe-first strategy therefore does not exclude early FDA interaction. The two can run in parallel.
Europe can be a more cost-efficient location for a first clinical trial while preserving a future US pathway.
The European clinical trial environment is substantial. EMA reported that CTIS received around 200 new initial applications per month between January 2023 and January 2025, including approximately 80 multinational trials per month.
For an early-stage biotech, a Europe-first strategy can also provide an opportunity to generate initial human evidence at lower cost before committing the resources required for the next stage of a global development program. In some cases, Phase I and proof of concept costs can be up to 40% lower in the EU.
The stronger strategic question is whether a particular European country offers the best combination of patients, investigators, timelines, infrastructure, costs and regulatory conditions for the study.
The decision should therefore consider:
CTIS has its own procedures, and first-time sponsors often make avoidable mistakes. Gouya Insights supports early-stage sponsors with this type of strategic planning, from indication and country selection to clinical development and regulatory strategy.
If you are deciding where to conduct your first clinical trial, a free Expert Hour provides an opportunity to discuss the specific needs of your program.
About the Author
PD Dr. Ghazaleh Gouya-Lechner is the founder of Gouya Insights and a cardiologist with over 20 years of hands-on clinical practice. She has worked across clinical development, regulatory strategy, and pharmacovigilance for both pharmaceutical and medical device companies. In 2017 she founded Gouya Insights, a CRO supporting early-stage biotech and medtech companies through clinical trials and drug development.
Frequently asked questions
What is 21 CFR 312.120?
21 CFR 312.120 establishes the conditions under which a foreign clinical study not conducted under a US IND can support a future IND or marketing application. The study must follow good clinical practice, including independent ethics committee approval and documented informed consent.
FDA must also be able to validate the data through an onsite inspection if necessary.
Can a US biotech conduct a European trial without an IND and submit the data to FDA later?
Yes. A US biotech can conduct an independent European clinical trial without an active US IND. If the study satisfies the requirements of 21 CFR 312.120, the resulting data can later support an IND or marketing application submitted to FDA. However, satisfying 21 CFR 312.120 does not guarantee that FDA will consider the study design, endpoints, population or resulting evidence sufficient for a particular development decision.
Does FDA need to agree with the European protocol before the trial starts?
No. FDA approval of the protocol is not required for an independent European trial that is not conducted under a US IND. However, obtaining FDA feedback before the trial starts can reduce the risk that the sponsor later discovers that FDA disagrees with an important element of the study design.
What is a pre-IND meeting?
A pre-IND meeting is a formal interaction that allows a sponsor to obtain FDA feedback before submitting an IND. Topics can include the nonclinical program, clinical trial design, data required for the IND and other aspects of the development program. There is no FDA fee for pre-IND meetings.
When should a sponsor request a pre-IND meeting?
If a European trial is intended to support future US development, the sponsor should consider requesting FDA feedback before the trial begins. This allows potential concerns about the design, endpoints, patient population, manufacturing strategy or supporting data to be addressed before patients are enrolled.
Is European data alone enough for full FDA marketing approval?
Potentially. Approval based solely on foreign clinical data is governed by 21 CFR 314.106. FDA considers whether the foreign data are applicable to the US population and US medical practice, among other requirements. Many sponsors therefore use European data as part of a broader international development program rather than as the sole basis for approval.
Does a European trial need to allow an FDA inspection?
If the sponsor intends to rely on a foreign study under 21 CFR 312.120, FDA must be able to validate the data through an onsite inspection if the agency considers one necessary.
Sponsors should therefore ensure that sites, records, source data and supporting systems remain accessible and inspection-ready for both FDA and EMA.
Will the FDA accept a study conducted entirely in one foreign population?
Yes. FDA will consider whether the results can be applied to the intended US population. Depending on the product, disease and study population, additional US or international data may be needed. FDA’s September 2026 comments on foreign clinical research make population generalizability an increasingly important consideration when planning predominantly foreign development programs.
Does Europe have an FDA equivalent?
Not exactly. The European Medicines Agency coordinates the scientific evaluation and supervision of medicines across the EU, but individual clinical trials are authorized through the EU Clinical Trials Regulation rather than by a single FDA-equivalent authority.
Clinical trial applications are submitted through CTIS and assessed by the relevant EU member states through a coordinated process. Since 31 January 2025, all EU clinical trials have operated under the Clinical Trials Regulation framework.
References
Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials
