Europe: CTIS, National Authorities, and Specific Pathways
In Europe, clinical trials involving medicinal products are governed by the Clinical Trials Regulation (EU) 536/2014. Since January 31, 2023, all new clinical trial applications in the European Union must be submitted through CTIS, the Clinical Trials Information System.
The EMA operates CTIS, but it is not the authority that approves clinical trials. The assessment is performed by the national competent authorities of the Member States concerned, for example ANSM in France, BfArM or the Paul Ehrlich Institut in Germany depending on the type of product, or AIFA in Italy. Ethics committees are also involved according to national rules.
In France, ANSM is involved in the regulatory and scientific assessment, while a Comité de Protection des Personnes (CPP) reviews ethical aspects and participant protection.
For medical devices, the framework is different. Clinical investigations fall under MDR 2017/745 and ISO 14155. IVD studies and post market studies may also follow specific requirements.
Sponsors must therefore identify the right framework from the beginning: medicinal product, medical device, in vitro diagnostic, interventional study, observational study, or post market study.
United States: FDA, IND, IDE, and IRB
In the United States, the framework depends on the product being evaluated.
Trials involving investigational drugs generally require the submission of an IND, or Investigational New Drug application, to the FDA. An IND becomes effective 30 days after it is received by the FDA, unless the agency places the study on clinical hold. The trial may also start earlier if the FDA authorizes the launch in writing.
For certain significant risk medical devices, an IDE, or Investigational Device Exemption, may be required before conducting the study.
In all cases, the involvement of an IRB, or Institutional Review Board, remains essential. The IRB notably assesses participant protection, informed consent, the benefit risk balance, and the documents provided to patients.
Many trials must also be registered on ClinicalTrials.gov depending on their regulatory scope. This obligation does not apply to all studies, but it does apply to many clinical trials in the United States.
The US system places strong emphasis on documentation, data integrity, participant protection, and compliance with 21 CFR Part 11 requirements when electronic systems are used.
United Kingdom and Canada: Structured Procedures
In the United Kingdom, the regulatory framework relies mainly on the MHRA for regulatory assessment and on Research Ethics Committees for ethics review. The Combined Review model coordinates these two dimensions within a unified process.
Since Brexit, the United Kingdom has developed its own framework while maintaining an approach close to international standards. Timelines may vary depending on the complexity of the study, the questions raised, and the quality of the dossier.
In Canada, trials involving investigational drugs require a Clinical Trial Application to Health Canada. Research ethics boards remain necessary to authorize the study at site level.
For medical devices, IVD studies, or post market studies, procedures may differ and depend on the type of product, the level of risk, and the applicable local framework.
Both frameworks offer structured procedures, but they require complete documentation and strong coordination between regulatory, clinical, and operational teams.
Asia: Regulatory Frameworks in Convergence
Asian countries follow different frameworks, although they are progressively converging toward ICH standards. For international sponsors, the main challenges relate to local documentation, language requirements, legal representation, and the acceptability of foreign data.
In Japan, the PMDA and MHLW play a central role. The system relies notably on the Clinical Trial Notification. Japan pays particular attention to the representativeness of Japanese participants and to the justification for extrapolating data from multiregional trials.
In China, the NMPA and CDE oversee clinical trials. The implicit approval mechanism has accelerated certain processes: in the absence of objections or clarification requests within the applicable timeline, the study may be considered authorized according to the relevant framework.
In South Korea, the MFDS oversees clinical trial applications. The country relies on a structured framework aligned with ICH standards and has strong experience in international multicenter trials.
In India, the CDSCO and DCGI are involved in clinical trial authorization. Requirements have been strengthened through the New Drugs and Clinical Trials Rules, particularly regarding participant protection, ethics committees, and sponsor responsibilities.
For multiregional trials, ICH E17 provides a useful framework for designing studies capable of producing data acceptable across several regions.
Why Does This Regulatory Diversity Make Multinational Trials More Complex?
Conducting a multinational trial means coordinating several reference frameworks in parallel. Teams must anticipate the timelines specific to each authority, prepare translations, adapt local documents, and ensure consistent data collection across all sites.
This complexity increases costs and extends timelines. A discrepancy between protocol versions, eCRFs, or consent forms can compromise the acceptability of the final dossier or create protocol deviations between countries.
The main challenges include:
- synchronizing regulatory submissions
- managing protocol versions
- ensuring consistency across consent forms
- translating patient documents
- progressively activating sites
- training local teams
- maintaining data quality across countries
- managing access rights
- ensuring traceability of corrections
- preparing exports for analysis
Regulation is therefore not limited to initial authorization. It influences the entire conduct of the study, from protocol design to database lock.
How Datacapt Helps Manage Multicenter and International Trials
In a multinational trial, teams must ensure consistent data collection across countries, sites, and protocol versions.
With Datacapt, sponsors, CROs, and medical device manufacturers can configure their data collection environment according to the study organization:
- multilingual eCRFs
- management of sites and access rights
- roles adapted to local teams, investigators, monitors, and data managers
- consistency checks to limit data entry errors
- queries to track corrections
- data completion monitoring
- complete audit trail
- structured exports for analysis
- ePRO, eConsent, or randomization according to protocol needs
Datacapt helps teams work in a validated, traceable, and auditable environment aligned with applicable requirements such as FDA 21 CFR Part 11, EU Annex 11, ICH GCP, and ISO 14155 depending on the study context.
This configuration makes it easier to maintain data consistency across sites and limits risks related to versions, access rights, and manual corrections.
Conclusion
Clinical trial regulations vary by country, but also by study type. A drug trial, a medical device investigation, an IVD study, an observational study, or a post market study do not always fall under the same procedures.
For sponsors and CROs, the success of an international trial depends on two complementary dimensions: identifying the right regulatory framework for each country and ensuring consistent data collection across sites.
A well-configured eClinical environment helps manage eCRFs, access rights, languages, queries, audit trails, and exports more effectively. This preparation reduces operational risks and helps teams run multicenter studies with greater consistency.
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