Author: PD Dr. Ghazaleh Gouya-Lechner, Founder, Gouya Insights | Last reviewed: June 2026
From 31 January 2025, every new clinical trial in the European Union and European Economic Area must be submitted, managed, and tracked through a single digital platform: the Clinical Trials Information System, known as CTIS. CTIS is the mandatory entry point for your application, your ongoing communications with regulators, and your trial’s public record. There is no alternative national route for trials initiated from that date onwards.
This article covers what CTIS is, how a submission is structured, what the 2024 transparency rules mean for your dossier, country-specific opportunities within the system, the most common submission pitfalls, how secondary use of samples and post-trial access are handled, and practical resources for getting started.
CTIS is the EU-wide platform that replaced 27 separate national submission systems with one. Created under Regulation (EU) No 536/2014, also known as the Clinical Trials Regulation or CTR, it was built to solve a straightforward problem: before CTIS, a sponsor running a trial in Austria, Germany, and France simultaneously had to manage three parallel submissions, three sets of national documents, and three independent review processes. One application now covers it all.
From a regulatory standpoint, CTIS serves four main functions.
A CTIS submission is divided into two parts, assessed by different bodies on different timelines, both of which must be approved before a trial can begin.
Part I covers everything related to the investigational medicinal product and the scientific basis of the trial. This includes the Investigator’s Brochure (IB), the Investigational Medicinal Product Dossier (IMPD), the Clinical Study Protocol (CSP), and the scientific rationale for the study. Part I is assessed collaboratively: one member state takes the lead as the Reporting Member State, and the other participating countries review and comment in parallel.
Part II covers the national and site-specific elements: ethics committee review, patient-facing documents including the informed consent form, and any country-specific requirements related to local regulations, privacy law, or reimbursement.
Both parts must be fully approved before any trial site can be activated. They are submitted as one single document. Managing both timelines is one of the most common operational challenges in first CTIS submissions. Sponsors need to assign roles within the platform, plan their redaction strategy, and track Part I and Part II timelines in parallel from the start, since delays in either stream affect the overall timeline.
Since 18 June 2024, most information about an authorized trial becomes public through the CTIS portal. This includes the protocol, the scientific basis of the trial, the results summary, and the lay summary written for patients. Sponsors may prepare both a complete version for assessment by authorities and ethics committees, and a redacted version for publication with confidential information blacked out where justified.
Commercially confidential information (CCI) and personal data can be protected, but only with a documented justification submitted as part of the application. This is not automatic. Sponsors must proactively identify which elements of their dossier qualify and prepare a redaction justification that distinguishes genuine CCI from general scientific information, which does not qualify.
Teams that approach this at the last minute frequently discover that their justifications are insufficient or that they have not drawn the right boundaries between what is and is not protectable. Your redaction strategy should be part of your CTIS preparation. Align your legal, regulatory, and clinical teams on this before submission.
Austria, Belgium, and Germany have the goal to shorten review timelines to less than a third of the EU-wide average. Dossiers there take approximately 35 days, while the EU-wide average sits at around 110 days.
The 35-day timeline is only available to applications that are complete and correct from day one. A submission with gaps in the IB or IMPD, the protocol, or the national documents will not move faster than a standard application.
Across the submissions we have supported, there is a set of problems that accounts for the majority of delays and regulatory questions.
The Most Common CTIS Submission Mistakes (and How to Avoid Them)
IMPD quality deficiencies are the most frequent source of Part I review questions. The recurring issues are insufficient stability data, inadequate comparability justification after manufacturing changes, and missing or poorly justified specifications. Reviewers also expect preclinical data to be framed in terms of human risk: what it means for dose selection, safety monitoring, and patient eligibility. An IMPD that does not make those connections will generate requests for information (RFI).
The same framing problem appears in the Investigator’s Brochure. Reviewers expect the IB to explain what non-clinical findings imply for human risk, which safety signals to monitor, and where the preclinical models have limitations. An IB that reads as a summary of experiments rather than a clinical risk document is a common source of questions, particularly when sponsors have drafted it without regulatory writing support.
Part II is where national differences matter. CTIS harmonized Part I assessment, but each member state retains its own requirements for ethics review, informed consent, data protection, and patient rights. Consent forms that are too generic, too long, or translated accurately but not written for a layperson create revision cycles that delay site initiation.
Operational gaps in first submissions are common and preventable. Once a submission is in, timelines are largely fixed and the main obligation is responding to any RFI within the deadline. The most avoidable gap is not preparing for those RFIs before they arrive, which means identifying where the dossier is weak before the authority does. Underestimating the time required for redaction strategy is another frequent oversight.
Two elements that sponsors overlook are secondary use of biological samples and post-trial access arrangements, both of which are country-specific.
Secondary use of samples refers to whether biological samples collected during the trial can be used for purposes beyond the primary research question, such as biomarker research or future studies. Each member state has its own legal and ethical framework for this, and the informed consent form must reflect the specific permissions being requested in that country.
Post-trial access (PTA) refers to whether or how patients can continue to access the investigational treatment after the trial has ended. This is relevant for rare diseases, oncology or other severe or life-threatening diseases where patients may have no alternative treatments. The arrangements should be specified in the protocol and the patient-facing documents, and they need to be realistic given the regulatory and commercial status of the product at the time the trial closes.
Sponsors who address these points with default text copied from a previous trial in a different country often receive ethics committee questions that add weeks to the Part II review.
| Resource | What It Covers | Where to Find It |
|---|---|---|
| EMA CTIS Sponsor Handbook (March 2026) | Primary operational guide: role management, submission workflows, publication settings, deadline tracking | Download Sponsor Handbook (PDF) |
| EMA Sponsor FAQ | Current questions on CTIS functionality, CTR interpretation, and country-specific submission points. Updated regularly. | Download FAQ Document (PDF) |
| EMA Walk-in Clinics and Bitesize Talks | Training and support page listing all upcoming live sessions where sponsors can ask operational questions directly to EMA staff. | EMA Training & Support Page |
| EMA CTIS Service Desk | Support for platform access issues, technical errors, and submission system questions | EMA Contacts Directory |
| EudraLex Volume 10 | The full clinical trials regulatory framework: CTR text, guidance documents, Q&A, and national contact points for each member state | EudraLex Volume 10 Hub |
| National Contact Points | Country-specific requirements for Part II documents, ethics review, and consent form content — listed in Annex III of the Q&A document | Download Annex III Q&A (PDF) |
The problems sponsors encounter at submission time are usually created during preclinical and early drug development, when no one is thinking about the clinical steps.
One company came to us to develop the clinical study protocol for a topical drug for skin damage. They were ready to enter the clinical stage. When we reviewed the development package, we found two gaps. The first was formulation: the drug had been developed as a solution, but a solution does not stay in place in the skin. The appropriate formulation was a gel or cream, but switching formulation requires demonstrating that the molecule retains its properties in the new form and releases appropriately. The second gap was treatment duration: the indication selection was chronic damage, which required a minimum of four weeks of treatment to generate meaningful clinical data, but the company’s toxicology studies covered only one week of exposure. Both gaps required new experiments before the trial could proceed.
These problems had the same root cause. The team had moved through preclinical development without picturing the clinical trial requirements. If those questions had been part of the development plan from the start, the formulation program and toxicology package would have been designed accordingly.
This is one of the most common patterns we see. CTIS does not create these problems, but it makes them visible at the point where they are already costly to fix. The investment in early regulatory planning is what determines whether a submission moves smoothly through review or triggers a cascade of questions and clock stops.
What does CTIS stand for and what is it used for?
CTIS stands for Clinical Trials Information System. It is the EU-wide platform for submitting clinical trial applications, managing the trial lifecycle, and publishing trial information under Regulation (EU) No 536/2014. Every sponsor planning a clinical trial in the EU or EEA must use it.
Do I have to use CTIS for my clinical trial in Europe?
Yes. Since 31 January 2025, all new clinical trial applications in the EU and EEA must go through CTIS. There is no national submission alternative for trials initiated after that date.
How long does it take to get a clinical trial approved in Europe through CTIS?
It depends on the member state and the quality of the dossier. Austria, Belgium, and Germany aim for approximately 35 days for mono-national applications, less than a third of the EU-wide average of around 110 days. The 110-day figure reflects real calendar time from submission to decision, which includes split timelines between authorities and sponsor for information requests and validation periods. Dossiers with gaps extend the review process and may not be feasible to answer RFIs within the given time, triggering a rejection of the application.
What is the difference between Part I and Part II in CTIS?
Part I covers the scientific and product-level content of the application and is assessed in a coordinated way across all participating member states. Part II covers national and site-specific elements, including ethics review and patient-facing documents, and is assessed independently by each member state. CTIS harmonised the submission process and the Part I assessment, but Part II remains national. Each member state retains its own legal requirements for ethics review, informed consent, and data protection, which the CTR did not standardize. However, the communication with the local ECs is facilitated as the documents are submitted in one portal and forwarded internally.
What information about my clinical trial will become public through CTIS?
Since 18 June 2024, once a trial is authorized, most core information becomes publicly available through the CTIS portal, including the protocol and results summaries. Commercially confidential information and personal data can be protected, but only with a documented justification submitted as part of the application. This is not automatic and must be planned before submission.
Can I start a clinical trial in just one EU country through CTIS?
Yes. CTIS supports both mono-national and multi-country applications. For early-phase trials, starting in a single country such as Austria is a common and practical approach that allows sponsors to move faster before expanding.
What is an Investigator’s Brochure?
The Investigator’s Brochure (IB) is the document that compiles all available clinical and non-clinical information about the investigational product to guide investigators conducting the trial. It is the primary document where non-clinical findings are expected to be contextualized for human use, covering what safety signals to monitor, what the preclinical models can and cannot tell us, and what the findings imply for patient risk.
Why does an Investigator’s Brochure frequently require revision?
Sponsors who draft their own IB without regulatory writing support often produce a document that reads as a summary of experiments rather than a clinical risk document, which is one of the most common sources of questions during Part I review.
What is an IMPD and what does it cover?
The Investigational Medicinal Product Dossier (IMPD) contains the quality and manufacturing information for the investigational product. The quality module covers specifications, stability data, and comparability justification following manufacturing changes. A separate non-clinical module exists but is optional and is less commonly the primary source of regulatory questions, since most non-clinical data are addressed in the IB. The IMPD quality module is typically prepared by manufacturing vendors, but sponsors remain responsible for ensuring it is complete and current before submission.
How early should we start preparing a CTIS submission?
For a first submission, preparation should begin at least one year before the target submission date, when work on the main regulatory documents (e.g., the clinical study protocol) starts. The final three to six months should be dedicated to the operational CTIS activities. This allows time to resolve IMPD gaps, prepare national documents, develop a redaction strategy, assign platform roles, and align the clinical and regulatory team before the review process starts.
Why do informed consent forms still need to be adapted per country if CTIS has harmonized the process?
CTIS harmonized the submission platform and the Part I scientific assessment, but Part II remains national. Informed consent forms must reflect the legal requirements of each member state, including national data protection rules and language expectations, which the CTR may not standardize. The same applies to secondary use of samples and post-trial access, both of which are governed by national bioethics and data protection law.
References
[1] European Medicines Agency. Clinical Trials Regulation (EU) No 536/2014 and CTIS transparency rules applicable from 18 June 2024. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-regulation
[2] European Commission and Member States. Joint Recommendations on Recurrent Submission Deficiencies in CTIS Applications. EudraLex Volume 10. https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en
[3] Pharma Intelligence. Clinical Trial Approvals in EU: Pharma Pushes for 60-Day Standard as CTR Delays Persist. September 2025. https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/clinical-trial-approvals-in-eu-pharma-pushes-for-60-day-standard-as-ctr-delays-persist-CY6FBHYTVNGCHN6RQDSQ3RFCLY
[4] BASG (Bundesamt für Sicherheit im Gesundheitswesen). Clinical trials of medicinal products. Austrian Federal Office for Safety in Health Care. https://www.basg.gv.at/en/healthcare-professionals/clinical-trials/clinical-trials-of-medicinal-products.
[5] European Medicines Agency. CTIS Sponsor Handbook (March 2026). https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-sponsor-handbook_en.pdf
[6] European Medicines Agency. CTIS Sponsor Frequently Asked Questions (March 2026). https://www.ema.europa.eu/en/documents/presentation/clinical-trial-information-system-ctis-frequently-asked-questions_en.pdf
[7] European Medicines Agency. CTIS Training and Support — Walk-in Clinics, Bitesize Talks, and Sponsor Resources. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-ctis-training-support
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.
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
