6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

Select Page
a

EUROPEAN MEDICINES AGENCY VS FOOD

AND DRUG ADMINISTRATION FOR
APPROVING NEW MEDICINES
by Nicole Brooks | Jul 10, 2024 | European Medicines Agency, Marketing Authorisation
Application

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 1/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

Highlights
Introduction
New drug evaluation process
EMA
FDA
Interactions with the EMA and FDA
EMA
FDA
Type A meeting
Type B meeting
Type B End of Phase (EOP) meeting
Type C meeting
Type D meeting
INTERACT meeting
Parallel EMA/FDA Scientific Advice
Table 1 – Summary of EMA vs FDA drug approval
How Somerville Development Partners can help
Get in touch
Author
References
Subscribe to our Monthly Regulatory Intelligence Scan

The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) are
responsible for evaluating and approving new medicines. But how are they similar and how do
they differ?

Highlights
The different drug approval evaluation processes

Types of interactions developers have with the EMA and FDA

Fast-to-market pathways

EMA vs FDA evaluation timelines

Introduction
2
The EMA is responsible for evaluating and approving medicines throughout the European Union
and its associated member states, whereas the Food and Drug Administration (FDA) approves
medicines for the United States.

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 2/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

The application to the EMA is known as a Marketing Authorisation Application (MAA) and covers
both small molecules, biologics and cell and gene therapies (known as advanced therapy
medicinal products (ATMPs) in Europe). Applications to the FDA are known as a New Drug
Application (NDA) or a Biologics License Application (BLA) – the latter includes cell and gene
therapies.

Both the EMA and FDA accept application submissions in the form of the Common Technical
Document (CTD).

New drug evaluation process

EMA
The Committee for Medicinal Products for Human Use (CHMP) is responsible for evaluating MAA
applications relating to small molecules and the Committee for Advanced Therapies (CAT)
oversees applications for ATMPs.

Before the scientific evaluation even begins, your MAA dossier will be validated by the EMA. If
your MAA dossier passes validation, the scientific evaluation will begin. If your MAA dossier
doesn’t pass validation, the EMA will request Validation Supplementary Information (VSI), and
you will be given 2 months to provide this information. If you do not meet the 2-month deadline,
1
you will be given a negative validation.

For more information on the specific things you must do leading up to submitting your MAA to the

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 3/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

EMA, please read our blog on how to get a drug approved by the EMA.

FDA
When you submit an NDA/BLA to the FDA, it will initially be reviewed for filing issues, which will
be expressed to the applicant within 14 days after an initial 60-day filing date. If the FDA decides
that there are significant issues with the NDA/BLA application, they will serve a refuse-to-file
2
notice.
3
If your application is filed successfully, the FDA has between 6 to 10 months to evaluate and
approve your medicinal product. Committee members conduct reviews on different sections of
your application, e.g., a medical officer and statistician will review the clinical sections and a
pharmacologist will review the non-clinical sections. The FDA inspectors will also conduct
inspections of your clinical study sites.

A designated project manager will compile individual reviews into an ‘action package’, the final
document reviewed by the FDA.

Both NDA and BLA applications require the application form FDA 356-h, which stipulates the
4-5
documents required as part of the application.

The FDA recently published a guidance detailing how it assesses the benefits and risks of new
medicines.

Interactions with the EMA and FDA

EMA
The EMA offers medicine developers Scientific Advice from early development stages. This is an
opportunity to ask the EMA integral questions about your development strategy. You can receive
advice from different experts on quality, non-clinical, clinical, and general development aspects of
your product development to date.

You can—and the EMA recommends—that you open MAA pre-submission interactions with the
committees within the EMA before you submit your MAA. This is to ensure you meet the relevant
legal and regulatory requirements in advance of your MAA submission and to promote a smooth
evaluation of your MAA once it has been submitted.

At the time of submitting your MAA, the EMA offers pre-submission interactions, allowing you to
meet the EMA project lead and other EMA team members involved in evaluating your MAA.
Depending on the topics you wish to discuss, members of different committees within the EMA
(orphan medicines, SME, paediatric medicines, CMC, and specialised disciplines) may be called
upon to assist you. 2
You must submit the MAA pre-submission interactions form and include specific draft annexes
relating to Module 1 of the MAA dossier.

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 4/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

The EMA will discuss your questions internally and respond in writing within 3 weeks of your
6
request. To highlight the usefulness of the EMA pre-submission interactions, their written
6
responses may also include additional guidance such as:

A proposed revision to the legal basis for your MAA,

views on the possibility of requesting approval under exceptional circumstances or conditional
approval, and
proposed revisions to MAA dossier modules based on the data you provided.

FDA
The FDA offers meetings throughout your drug development process and during the NDA/BLA
evaluation procedure, and they are categorised into different types: A, B, (end of phase; EOP), C,
D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER Products
7
(INTERACT).

Type A meeting
These are predominantly used for stalled products to discuss clinical holds; important safety
issues and in response to the FDA submitting a refusal-to-file letter.

Type B meeting
These meetings are held to discuss pre-investigational new drug (IND) and pre-NDA concerns,
as well as the development programme for medicines granted breakthrough therapies.

Type B End of Phase (EOP) meeting

Much like the EMA’s scientific advice procedures, these meetings occur at the end of phases 1
and 2 of medicine development.

Type C meeting
These are reserved for any other type of discussion a medicine developer needs regarding
development or product review.

Type D meeting
These types of meetings are intended to discuss a small set of issues that arise at important
decision points during a development programme. This meeting should only include two focused
subjects.

INTERACT meeting
This type of meeting is reserved for novel medicinal products and novel development
programmes, which often present unique developmental challenges. 2
Parallel EMA/FDA Scientific Advice
If you’re planning to file a new drug application (NDA) in the US and an MAA in Europe, parallel

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 5/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

scientific advice (PSA) between the EMA and the FDA may be helpful.

Areas of therapeutic and developmental interest between the EMA and FDA include oncology,
paediatric medicines, orphan medicines, vaccines, nanotechnologies, blood products, and
8
advanced therapy medicinal products (ATMPs)/biologics.

You will receive separate advice letters from each agency to review. This is an important feature
of PSA because separate scientific advice comments could provide invaluable guidance to
increase your chances of gaining approval for your MAA and NDA.

Be aware that the scope of changes you may be advised to make—particularly to your pivotal
clinical trial designs—may change due to receiving comments from both the FDA and EMA in
parallel.

Table 1 – Summary of EMA vs FDA drug approval

EMA FDA

Application MAA NDA/BLA

Committees CHMP/CAT CDER/CBER

Submission format CTD CTD

1 2
Evaluation timeline 210 days + 2 clock stops 10 months

Faster evaluation Accelerated assessment Fast-track

How Somerville Development Partners can help

We can support every aspect of your MAA filing, including the following:
Developing a Common Technical Document (CTD) table of contents for the submission.
Conducting a gap analysis to ensure that all submission components have been identified and
planned.
Preparing key messaging and the company core data sheet.
Preparing regional labelling such as the Summary of Product Characteristics and US
Prescribing Information.
Planning the data presentation, analysis and discussion in the dossier.
Conducting detailed reviews of the data (tables, figures and listings) shells to ensure the
required analysis and outputs are planned.
Writing Modules 1–5 of the electronic CTD.
Publishing and submitting the completed submission. 2
Responding to questions from the agency during the evaluation.
We frequently, work as part of the global filing team for parallel submission to the US, EU and
additional authorities. If possible, it is worthwhile writing a submission with common US and EU

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 6/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

Module 2–5 components, especially the Module 2 summaries, so that multiple consistent
submissions can be made to streamline regulatory agency interactions.
We can also provide peer review of existing projects, to stress-test the work that has been
done and recommend solutions to address any gaps. Peer review may be especially useful to
prepare for the MAA submission, where an additional perspective may help to highlight any
potential risks.

Get in touch
We welcome the opportunity to discuss scientific advice and regulatory strategy with
you!

Email Tom

Author
Nicole Brooks
[email protected]

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 7/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

References

1. European Medicines Agency. (2024). The evaluation of medicines, step-by-step. Available at:
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/evaluation-
medicines-step-step

2. FDA (2018). NDAs and BLAs: Filing Review Issues. Manual of Policies and Procedures.
Center for Drug Evaluation and Research. MAPP6010.5. Available from:
https://www.fda.gov/media/72700/download

3. FDA (2017). The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective.
Available from: https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-
review-process-ensuring-drugs-are-safe-and-
effective#:~:text=In%20accordance%20with%20the%20Prescription,six%20months%20for%20priority%20dru

4. FDA (2022). New Drug Application (NDA). Available from: https://www.fda.gov/drugs/types-

applications/new-drug-application-nda

5. FDA (2021). Biologics License Applications (BLA) Process (CBER). Available from:
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-
license-applications-bla-process-cber

6. European Medicines Agency (2024). Human regulatory-Marketing Authorisation-Pre-

authorisation Guidance. Available at: https://www.ema.europa.eu/en/human-regulatory-
overview/marketing-authorisation/pre-authorisation-guidance

7. FDA (2023). Formal meetings between the FDA and Sponsors or Applicants of PDUFA
products: Guidance for Industry. Draft guidance. Procedural revision 1. Available from:
https://www.fda.gov/media/172311/download

8. European Medicines Agency (2021). General Principles EMA-FDA Parallel Scientific Advice
(Human Medicinal Products). Available at:
https://www.ema.europa.eu/en/documents/other/general-principles-european-medicines-agency-
food-drug-administration-parallel-scientific-advice_en.pdf

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 8/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application

Subscribe to our Monthly Regulatory Intelligence

Scan
Our monthly newsletter gives you the latest European and UK regulatory intelligence. We
bring you new and interesting approvals; fast-to-market applications, orphan
designations; paediatric applications and therapy area-specific news.

Your first name Your last name

Email address

Subscribe

You can unsubscribe at any time from the link in the newsletter footer. Read our Privacy Policy
here.

SERVICES

Regulatory Planning and Due Diligence

Scientific Advice and Protocol Assistance

WORK WITH US Priority Medicines Initiative (PRIME) and Innovation

Licensing & Access Pathway (ILAP)

Paediatric Investigation Plan (PIP)

Orphan Drug Designation

Marketing Authorization Application

Medical Writing

Target Product Profile (TPP) Development

RESOURCES CONTACT

Articles [email protected]
2
Webinars
United Kingdom
Applying for Orphan Designation
Somerville Development Partners Ltd
Submitting Marketing Applications 2 Victoria Square, Fountain Court,
St Albans, Hertfordshire, AL1 3TF
Creating an effective Regulatory Plan

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 9/10
6/19/25, 1:40 PM EMA Marketing Authorisation vs FDA New Drug Application
Agreeing a Paediatric Investigation Plan with the +44 800 0209150
Paediatric Committee Company Number 14359932

Taking scientific advice and protocol assistance

(PRIME and ILAP) Netherlands
Somerville Development Partners BV
Glossary of Regulatory Deliverables Herengracht 420, 1017 BZ, Amsterdam
+31 20 244 6813
Company Number 88942198

Copyright © 2024 | All rights reserved | Privacy Notice | Cookies | Terms and Conditions

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/?utm_source=chatgpt.com 10/10