European Medicines Agency vs Food and Drug Administration for approving new medicines 

by | Jul 10, 2024 | European Medicines Agency, Marketing Authorisation Application

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

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.  

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, you will be given a negative validation.1 

Timeline of the EMA's MAA evaluation timeline

For more information on the specific things you must do leading up to submitting your MAA to the 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 notice.2

If your application is filed successfully, the FDA has between 6 to 10 months3 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 documents required as part of the application.4-5

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.

You must submit the MAA pre-submission interactions form and include specific draft annexes relating to Module 1 of the MAA dossier.

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

  • 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 (INTERACT).7

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.

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 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 advanced therapy medicinal products (ATMPs)/biologics.8

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

EMAFDA
ApplicationMAANDA/BLA
CommitteesCHMP/CATCDER/CBER
Submission formatCTDCTD
Evaluation timeline210 days + 2 clock stops110 months2
Faster evaluationAccelerated assessmentFast-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.
  • 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 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!

Nicole

Author

Nicole Brooks, Regulatory Consultant / Copywriter
Nicole@somerville-partners.com

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%20drugs

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