Last Updated: October 2026
What are the main types of regulatory submissions in the US (FDA) and the EU (EMA), and how do they compare?
In the US, sponsors file an IND to begin clinical trials and an NDA, BLA, or ANDA for drug marketing approval, while devices go through a 510(k), De Novo request, or PMA. In the EU, the equivalents are the Clinical Trial Application (CTA), filed through CTIS, and the Marketing Authorisation Application (MAA), filed with EMA; devices are CE marked under MDR or IVDR. Most drug dossiers use the eCTD format.
If you're new to regulatory submissions, they can seem a little confusing - and not just because there are so many acronyms to learn. To help you navigate the landscape, we offer this short guide to the most common regulatory submission types in the United States (FDA) and European Union (EMA), with links to more detailed information.
In this guide:
- What Are Regulatory Submissions?
- What Are Common Types of Regulatory Submissions?
- A Comparison of Regulatory Submissions in the US and EU
- Navigating the Regulatory Submission Process
- Avoiding Common Pitfalls in Regulatory Submissions
- Options for Managing Regulatory Submissions
- Regulatory Submissions with Kivo
- Frequently Asked Questions
What are Regulatory Submissions?
Regulatory submissions are comprehensive packages of documents and data submitted to health authorities, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), to demonstrate the safety, efficacy, and quality of a drug, medical device, or biotherapeutic. These submissions are a crucial part of ensuring the safety, efficacy, and quality of therapies, medicines, and devices.
The purpose of regulatory submissions is to provide detailed information about a product or service, including manufacturing processes, clinical trial results, labeling, and proposed usage. Regulatory authorities review these submissions to assess the risks and benefits associated with the product or service and make informed decisions about its approval, labeling, and post-market surveillance.
Understanding the regulatory submission requirements and processes is essential for companies operating in regulated industries, such as pharmaceuticals, medical devices, biotechnology, and food and beverages.
In life sciences, a regulatory submission can be the culmination of many years of work - and is a major factor in bringing a new product to market. Thus it's important to have a complete understanding of the submission process and how to set yourself up for approval!
What are Common Types of Regulatory Submissions?
There are many types of regulatory submissions, each serving a specific purpose on the path to approval in a given country or region. The most common types include:
- Investigational New Drug (IND) Application: Sponsors submit this application to the US Food and Drug Administration (FDA) to initiate clinical trials for new drugs. It includes data on the drug's safety and efficacy, the study protocol, and investigator information. Note that some drugs (or biologics) may qualify for an Emergency Investigational New Drug (EIND) Application. See our guide to submitting an IND.
- Clinical Trial Application (CTA): The CTA is the European equivalent of the IND. To submit a new CTA in the EU, you'll need to use the Clinical Trial Information System (CTIS) portal. Since 31 January 2025, all EU clinical trials, including those that began under the older Clinical Trials Directive, fall under the Clinical Trials Regulation and are managed in CTIS. See our CTA guide.
- Premarket Approval (PMA) Application: This submission is required for the approval of many high-risk medical devices in the US. Note that if your device is similar enough to an existing, approved device, you may be able to submit a simpler 510(k) Premarket Notification instead. For novel, moderate-risk devices with no predicate, there is also the De Novo pathway. It's important to evaluate your device's class and relation to any such 'predicate' devices to determine your submission path. See our guides to PMA, 510(k), and De Novo submissions.
- New Drug Application (NDA): This FDA submission is required for the approval of new pharmaceutical drugs in the US. It includes comprehensive data on preclinical studies, clinical trials, manufacturing processes, labeling, and proposed usage. NDAs are managed by FDA's Center for Drug Evaluation and Research (CDER). See our NDA guide.
- Abbreviated New Drug Application (ANDA): The ANDA option is a streamlined version of the New Drug Application for generic versions of brand-name medicines that have already been approved by the FDA. ANDAs can rely on existing data to demonstrate bioequivalence. ANDAs are regulated by the Office of Generic Drugs (OGD). See our ANDA guide.
- Biologics License Application (BLA): In the US, biologics - that is, drugs that are derived from living organisms - are classified separately for marketing approval. BLAs are overseen by the FDA's Center for Biologics Evaluation and Research (CBER). See our BLA guide.
- Marketing Authorization Application (MAA): This submission is required for the approval of new pharmaceutical drugs in the EU. It includes similar data as the NDA, but follows the guidelines set by the EMA. The Committee for Medicinal Products for Human Use (CHMP) evaluates marketing authorization applications, with input from the Pharmacovigilance Risk Assessment Committee (PRAC) on aspects of the risk-management plan and the Committee for Advanced Therapies (CAT) for advanced-therapy medicines. See our MAA guide.
These are just a few examples of the various types of regulatory submissions that companies may need to prepare and submit to regulatory authorities. It's important to stay apprised of the differences between countries. Efforts to align and coordinate global submissions, led by the International Council for Harmonisation (ICH) and ISO, are always ongoing.
For a sense of scale, CDER approved 46 novel drugs in 2025, and EMA issued positive opinions on 104 medicines in 2025, 38 of them new active substances. Each of those approvals rested on a submission package that had to be complete, consistent, and traceable.
A Comparison of Regulatory Submissions in the US and EU
The table below maps each major submission purpose to its US and EU counterpart.
| United States (US) | European Union (EU) | |
| Regulatory Authority | Food & Drug Administration (FDA) | European Medicines Agency (EMA), working with national competent authorities |
| Authorization for Clinical Investigations | Clinical Trial Application (CTA), submitted through CTIS | |
| Pre-Authorization (for Medical Devices) |
Premarket Approval (PMA) Application De Novo classification request |
No EMA premarket approval for most devices; conformity assessment with a Notified Body under MDR or IVDR leads to CE marking (see EU MDR vs. FDA regulations) |
| Marketing Applications | Marketing Authorisation Application (MAA) | |
| Dossier Format | eCTD for most drug and biologic applications | eCTD for medicinal product applications |
Navigating the Regulatory Submission Process
The regulatory submission process typically moves through four stages: preparation, compilation, review, and an approval decision. It requires careful planning and coordination. Some key steps in the process often include:
Preparing for the Submission
Companies need to gather all the required data and documentation for the submission, ensuring compliance with regulatory guidelines and requirements. In many cases, teams will request preliminary meetings with representatives from the relevant agency, which can be helpful in determining areas of focus for their submissions. Leveraging regulatory software to assist with authoring, submission building, and project management can significantly reduce human errors and ensure your documents will meet compliance requirements. For more on mapping timelines across markets, see how a RIM system supports global submissions planning.
Submission Compilation
The collected data and documentation are compiled into a submission package in the required format, which may include forms, reports, clinical trial data, labeling, and manufacturing information. For FDA submissions, the required format for most drug and biologic applications is the Electronic Common Technical Document (eCTD) format. Teams typically use specialized software to 'publish' their submissions in the eCTD format.
The eCTD standard itself is evolving. CDER and CBER have accepted new applications in eCTD v4.0 format since September 16, 2024; the FDA page we reviewed announces no mandatory date, so v3.2.2 remains in use alongside it. Read more in our guides to eCTD 4.0 and eCTD viewers.
Submission Review
Regulatory authorities review the submission package, assessing the data and information provided. This may involve multiple rounds of questions, clarifications, and additional data requests. Sponsor teams will often track this agency correspondence carefully, as it can be critical to their successful approval.
Approval Decision
Based on the review, the regulatory authority makes a decision on the approval or rejection of the submission. They may also provide specific labeling requirements or post-market surveillance obligations.
Navigating the regulatory submission process requires expertise in regulatory affairs, a thorough understanding of the applicable regulations, and effective communication with regulatory authorities. Kivo has been fortunate to partner with a number of excellent regulatory consultants - just let us know if you'd like a recommendation! For a deeper walkthrough, see our guide to the regulatory submission process.
Avoiding Common Pitfalls in Regulatory Submissions
The most common submission pitfalls are inadequate data, non-compliance, poor communication, and inconsistent documentation. The regulatory submission process can be complex, and being aware of these pitfalls helps companies both increase their likelihood of approval and avoid delays on their path to market.
- Inadequate Data: Insufficient or incomplete data can lead to delays or rejection of the submission. It is crucial to gather robust and comprehensive data to support the safety, efficacy, and quality of the product or service. Preliminary agency meetings early in the submission process can be a great way to learn which areas may be most important to support with comprehensive data.
- Non-compliance: Failing to comply with regulatory guidelines and requirements can result in rejection of the submission. It is essential to stay updated on the latest regulations and ensure full compliance throughout the submission process. A key mistake we often see is documents stored in file sharing systems that do not meet Part 11 requirements. This can be mitigated with a fit-for-purpose RIM system that will automatically assemble the audit trail as well as capture digital signatures.
- Poor Communication: Lack of effective communication with regulatory authorities can lead to misunderstandings and delays. It is important to maintain open and transparent communication, promptly addressing any questions or requests from the authorities.
- Inaccurate or Inconsistent Documentation: Errors or inconsistencies in the submission documentation can raise concerns about the reliability and accuracy of the data. It is crucial to review and double-check all documentation for accuracy and consistency.
By being aware of these common pitfalls and taking proactive measures to address them, companies can increase their chances of a successful regulatory submission.
Options for Managing Regulatory Submissions
Most teams manage submissions with a regulatory information management (RIM) system rather than spreadsheets and shared drives. The table below summarizes how Kivo and two other well-known options approach this, based on each vendor's published product information. This is not an independent ranking: it does not assess implementation quality, market share, or fit for any particular organization, so validate each option against your own requirements, submission volume, and team size.
| Option | Category fit | Typical use | Consider |
|---|---|---|---|
| Kivo RIM | Cloud-based RIM on a shared DMS core, with eTMF and QMS available on the same platform | Clinical-stage biotech sponsors and the partners that support them, pre-IND through approval | Prepares submission-ready packages for a publishing partner and includes a browser-based eCTD viewer; does not include eCTD publishing itself |
| Veeva Vault RIM | Enterprise RIM suite on the Veeva Vault platform, covering registrations, submissions, and publishing | Large, multi-product regulatory organizations with broad process scope | Match scope and implementation effort to your team size; see our Veeva RIM alternatives guide |
| Ennov regulatory suite | Regulatory suite with dossier and submission management and eCTD publishing | Teams wanting a dedicated life sciences regulatory vendor with publishing in the same suite | Review module scope and deployment model against your needs |
Whichever options you shortlist, run the same scorecard on each: compliance with Part 11 and Annex 11, how submissions are assembled and published, how agency correspondence is tracked, and how long implementation and validation take.
Regulatory Submissions with Kivo
Kivo is a cloud-based compliance platform for life sciences with a Part 11-compliant document management core and a RIM module built for clinical-stage regulatory teams. It supports INDs, CTAs, NDAs, BLAs, ANDAs, and more, with pre-built submission structures aligned to agency guidelines, 450+ pre-formatted ICH templates, agency correspondence and commitment tracking, and real-time co-authoring through Microsoft Office. Native electronic signatures are included in every subscription, and Kivo has a G2 rating of 4.9 out of 5 with 200+ sponsor, consultant, and CRO teams on the platform.
Kivo does not include eCTD publishing itself. It prepares submission-ready packages, with automatic change tracking, for handoff to your internal or external publishing partner, and keeps submitted eCTDs viewable in its eCTD viewer, linked back to the source documents. Implementation is measured in weeks, not months.
Frequently Asked Questions
What is the difference between an IND, an NDA, and a BLA?
An IND allows a sponsor to begin clinical trials in the US before a product is approved. An NDA requests marketing approval for a new drug, and a BLA requests approval for a biologic. Both marketing applications rest on completed clinical, nonclinical, and manufacturing data.
What is the EU equivalent of an IND?
The Clinical Trial Application (CTA) is the EU equivalent of the IND. It is submitted through the Clinical Trial Information System (CTIS). Since 31 January 2025, all EU clinical trials, including those started under the older Directive, fall under the Clinical Trials Regulation and are managed in CTIS.
Do medical devices go through the EMA?
Generally no. In the EU, most devices are CE marked after conformity assessment, often with a Notified Body, under MDR or IVDR rather than receiving an EMA approval. In the US, devices go through FDA pathways such as 510(k), De Novo, or PMA depending on risk and predicate availability.
Is eCTD v4.0 mandatory for FDA submissions?
CDER and CBER have accepted new applications in eCTD v4.0 format since September 16, 2024. The FDA page we reviewed announces no mandatory date, so eCTD v3.2.2 is still in use. Confirm current requirements in FDA's eCTD guidance before you compile a submission.
Does a RIM system publish eCTD sequences?
It depends on the system. Some RIM suites include eCTD publishing, while others prepare submission-ready packages for a separate publishing partner and keep submitted sequences viewable and linked to source documents. Confirm who owns publishing, and how it is validated, before you buy.
We hope this guide proves useful as you begin your regulatory journey. As you can see, the path to approval can be somewhat complex and requires a great deal of collaboration - both internal and external. In fact, that's one of the main reasons we created Kivo GO, to help teams work together more efficiently on their path to regulatory approval.
