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EMA Institution Profile | Drug Discovery & DDS

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INSTITUTION PROFILE

EMA
— The scientific reviewer whose centralized assessment can support approval of a new medicine across the EU

(European Pharmaceutical Agency) is an EU specialized agency and does not make drugs yourself. Rolesevaluate and approve new drug applicationsComment Committees placed within the scope of their evaluationCHMPComment The European Commission is not responsible for the final decision of the sales permit. In this article, you can seeHow much does drug discovery and DDS affect?Squeeze and organize.

Composition: Annual Activity Report (2025), Central Examination, Rapid Review, PRIME, CHMP official page, Science Guidelines, EPAR (European Public Evaluation Report) as primary information / Last updated September 2026

In this article
  1. 30 seconds
  2. What kind of organization is the type of influence?
  3. What is DDS?
  4. Scope of influence (authorization and region)
  5. Companies and organizations involved
  6. Future Prospects
  7. Glossary/Source/Ins ment and Source Response Table

1. 30 seconds

NameEuropean Medicines Agency
(European Pharmaceutical Agency)European Union
RegionEUAmsterdam, Netherlands 1995 - 2019 London
Type of OrganizationEU Professionals (Scientific Evaluation)A legal decision to sell is issued by the European Commission
Year 19952025
Number of people983 peopleTotal of temporary staff, contract staff and dispatch specialists in 2025. Thousands of members cooperate with committees and working groups
Approx. 6 billion euroFinal budget of 2025 €623 million. Income of 91.4% from review
Involvement in drug discovery and DDSCHMP's opinions and guidelinesCentral examination of new active ingredients such as cancer, diabetes, and biopharmaceu s is obliged
Impact rangeEU27+EEA3Iceland Liechtenstein Norway. Valid throughout with one approval
1 point to press

Our Strengths“All EUs in One Review”It is a mechanism. The drug approved by the Central Examination will be valid in all EU member countries and in three countries of EEA FactsHome EU lawitself does not have permission to sellHome European Commission gives a legally binding decision in response to the opinion of CHMP Within 67 days from receiving opinions) FactsHome In other words, the institution is not a "determining organization",Organizations that make the whole EU decisionComment

2. What kind of organization is the type of influence?

The drug discovery and DDS articles will not make medicines yourself, unlike companies. instead ofWhat pathways will affect the industry?is divided into four types.

4 types of drug discovery and DDS The body does not make medicine by yourself. 4 different routes to influence the industry Funding Decide on policies and regulations Set the standard Make a place to your budget Approval Guideline and Inspection International Harmony of Guidelines Presentation of clinical data NIH FDA／EMA／PMDA／NMPA ICH AACR／ASCO What to do What to Market How to apply Who Meets Scope to reach: budget of your country Scope of delivery: Local market Scope to reach: affiliates Scope to reach: Participants "Decide on Policy and Regulation" However, the decision is made by the European Commission. In order to receive one review from EU 27 countries and EEA 3 countries, companies from all over the world want to sell in Europe will be eligible
Figure 1　4 types of drug discovery and DDS related organizations, and the position of . The classification is based on this article, and the name of the organization is shown by eight institutions in this series. the formulation of this paperHome FDA is a type of regulation, but it is different from FDA and PMDA in terms of the right to determine permission is in the European Commission.

3. What is DDS?

The center of the examination isCHMP (Committee for Medicinal Products for Human Use)Comment CHMP is a committee located in the Middle Ages,Experts in science appointed by EU Member Statesof: In the central examination, we will be responsible for the initial evaluation of sales application throughout the EU and evaluation of changes after approval. Facts。

ActivitiesHomeNumbers/Examples (disclosed value)
Central Examination (CHMP)Evaluate and approve new drugs. Up to 210 daysYear 2025Productsapproval of new active ingredients38). 89 items
Procedures to Send FasterQuick review (shortening evaluation period to 150 days), conditional approval, approval under exceptional circumstances2025 Quick review 3, conditional approval 8, exceptional situation 2
PRIMEMarch 2016 Provide early advice to developers of drugs for unsatisfied medical needs174 certifications until July 2026, 445 rejected (Total of 174 applicants) the formulation of this paper). 6 PRIME items approved in 2025
adviceAdvice on developmental testing plans before application for approvalRequest for scientific advice and protocol support in 2025780 foundedHome 5 provide advice to other regulators
Guidelines for modalitiesShows the necessary contents for the application for the manufacture and quality control of new types of drugsDevelopment and manufacturing guidelines for peptides (December 2025)Applicable from June 1, 2026)/Development and manufacturing guidelines for oligonucleotide (nucleic acid) Opinion submission ends on January 31, 2025)
DDS point of view: Peptides and nucleic acids are maintained from the manufacturing guidelines

The two guidelines for this website are:Quality & ManufacturingHandling. The keyword of peptides guidelines is solid phase, liquid phase, and conjugation, FactsHome In nucleic acid drugs that combine peptide drugs such as GLP-1 and ligand, How to make and manage impuritiesis the condition of approval.

4. Scope of influence (authorization and region)

What you haveNot having
CHMPscientific opinions on how to approveDetermination of the status of rapid screening, PRIME certification, scientific adviceLegal Decision on Sales (Ex)ted by the European Commission)
RegionEU27+EEA3Home New active ingredients such as cancer, diabetes, and neurodegenerative diseases, biopharmaceu s, advanced medicines, and rare diseases are obliged to central examinationApproval of many postpartum products and general medicines (reviewed by the authorities of each member country)
Relationship with Member StatesThe members of the CHMP are appointed by members and evaluated by thousands of membersPermission to replace the examination of member countries for drugs not covered by central examination
International LocationThe FDA and PRIME Breakthrough Therapy have joint guidelines. ICH Joins EU as a Founding Member, EC, EuropeAuthorities for determining the availability of sales outside the EU
Notes on reading numbers

983 peopleTotal coverage including animal medicines and safety monitoringNumber FactsHome Because most of the valuation practices are carried out by the authorities of the member country, only the number of employees on this website does not represent the scale of the examination system. Personnel and amounts used only for drug discovery and DDS review are not published Undetermined / Future。

5. Companies and organizations involved

Central Examination Flow (EU) CH CHMP summarizes opinions and the European Commission makes decisions. The decision is valid in all EU and EEA countries Company Profile Daiichi Sankyo Europe Alnylam Netherlands Applicants listed in EPAR EMA CHMP Up to 210 days 150 days European Commission Legal binding decisions Within 67 days from receipt of opinion EU Member States Appoint a member of the CHMP and give an expert to evaluation EU27+EEA3 Example: Datroway (ADC) CHMP Opinion January 30, 2025 → Approval April 4, 2025
Figure 2　The flow of central examination of the Guest. Source:isation "Authorisation of medicines", "Ac rated assessment", CHMP introduction page, Datroway and Amvuttra's EPAR. The company lists only the candidates for the company commentary of this series, as well as those confirmed by the EPAR.
ProductApplicant (EPAR)CHMP Opinion → Approval
Datroway（datopotamab deruxtecan、ADC）Daiichi Sankyo Europe GmbHJanuary 30, 2025 → April 4, 2025
Amvuttra（vutrisiran、siRNA）Alnylam Netherlands B.V.21 July 2022 → 15 September 2022

6. Future Prospects

ReadPrimary Information
The EU's pharmacy law amendments, such as central examination and CHMPCommittee compositionSubstitute the frame by around 2028Oligonucleotide guidelines include solid phase, hosmidite, and linker conjugation
Specific examination period and data protection period after amendmentSpecifically, the revised text and changes are shown in detail during 2026.Undetermined / Future
The final version of the Origonucleotide guidelines and application dateCall for opinions ended on January 31, 2025. The final version is not yet on the left pageUndetermined / Future

7. Glossary

CHMP
Pharmaceuticals Committee. In the committee in the , an expert appointed by the member state evaluates and approves the application of new drugs.
Central Examination
Procedures evaluated by the European Commission. Effective in all EU and EEA countries with one approval
PRIME
A system of measures to boost the development of drugs for un ed medical needs with early advice. Lead to quick review.
Conditional Approval
A mechanism to quickly approve and submit complete data after approval.
EPAR
European Public Evaluation Report. Publish the contents of evaluation and approval recipients for each drug approved by the Central Examination.

8. Source

  1. EMA　Authorisation of medicines (no license to sell to you, the decision of the European Commission is valid within 67 days, in all EU member countries and in EEA three countries, the scope of the obligations, and after-sale examinations). https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
  2. EMA　Annual activity report 2025. 780 scientific advice and 5 provide advice, the final budget of 2025 €623 million, the breakdown of income, the number of employees (TA, CA, END) 983 people. https://www.ema.europa.eu/en/documents/annual-report/annual-activity-report-2025_en.pdf
  3. EMA　History of (founded in 1995, 1995-2019, 30th anniversary, thousands of members) https://www.ema.europa.eu/en/about-us/history-ema
  4. EMA　Committee for Medicinal Products for Human Use (CHMP) https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp
  5. EMA　Accelerated assessment (up to 210 days for central examination, 150 days for rapid examination, and PRIME start in March 2016). https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment
  6. EMA　PRIME: priority medicines (the purpose of the system, the number of applicants who apply until July 2026, and the FDA joint guidelines). https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines
  7. EMA　Development and manufacture of peptide peptides - guide guideline (published on December 9, 2025, applied on June 1, 2026). https://www.ema.europa.eu/en/development-manufacture-synthetic-peptides-scientific-guideline
  8. EMA　Development and manufacture of oligonucleotides - opinion guideline (drafts, proposals, proposals, and keywords). https://www.ema.europa.eu/en/development-manufacture-oligonucleotides-scientific-guideline
  9. EMA　Reform of the EU Pharmaceutical legislation (Poli。 Agreement on December 11, 2025, the efficacy of 2026, the transition period by 2028, the main field of amendment) https://www.ema.europa.eu/en/about-us/what-we-do/reform-eu-pharmaceutical-legislation
  10. EMA　Datroway EPAR (Approved by Daiichi Sankyo Europe GmbH, CHMP Opinion January 30, 2025, approval April 4, 2025, structure combined with antibodies and drugs). https://www.ema.europa.eu/en/medicines/human/EPAR/datroway
  11. EMA　Amvuttra EPAR (Alnylam Netherlands B.V., CHMP Opinion July 21, 2022, approval September 15, 2022, siRNA). https://www.ema.europa.eu/en/medicines/human/EPAR/amvuttra
  12. ICH　Members & Ob。s (Regulators at the time of establishment: EC, Europe/FDA, United States/MHLW/PMDA, Japan) https://www.ich.org/page/members-observers

9. Response table of claims and sources

Content
The European Commission decides within 67 days without permission to sell to the outside director, valid in all EU member countries and in EEA three countries, the scope of the obligation to central examination, and post-delivery, etc.FactsSource 1 https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
20 approved recommendations for 2025 (New active ingredient 38), 89 adaptation, 780 rapid review, conditional approval, exceptional situation, PRIME, 780 scientific advice, 5 concurrent advice, 623 million euro budget and 91.4% income, 983 employeesFactsSource 2 https://www.ema.europa.eu/en/documents/annual-report/annual-activity-report-2025_en.pdf
Established in 1995, in the London era, headquartered in Amsterdam, with thousands of expertsFactsSource 3 https://www.ema.europa.eu/en/about-us/history-ema
The role of CHMP and the composition of members appointed by expertsFactsSource 4 https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp
Up to 210 days, 150 days with rapid review, PRIME started in March 2016FactsSource 5 https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment
Purpose of PRIME, Authorization and Disapproval Number by Applicant, Joint Guidelines with the FDAFactsSource 6 https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines
Release and application date and keyword of peptides peptide guidelinesFactsSource 7 https://www.ema.europa.eu/en/development-manufacture-synthetic-peptides-scientific-guideline
Origonucleotide’s guideline proposals and period of time for submission, keywordsFactsSource 8 https://www.ema.europa.eu/en/development-manufacture-oligonucleotides-scientific-guideline
Poli Agreement, Effectiveness, Transition Period and AmendmentFactsSource 9 https://www.ema.europa.eu/en/about-us/what-we-do/reform-eu-pharmaceutical-legislation
Datroway Applicant and CHMP Opinion and Approval DateFactsSource10 https://www.ema.europa.eu/en/medicines/human/EPAR/datroway
Date of CHMP opinion and approval with Amvuttra approval recipient, siRNAFactsSource11 https://www.ema.europa.eu/en/medicines/human/EPAR/amvuttra
ICH, EU, EC, EuropeFactsSource12 https://www.ich.org/page/members-observers
174 PRIME certifications and 445 rejections (Total number of applicants)the formulation of this paperTotal number of source 6
Engine Four Mold Segmentthe formulation of this paperPurpose of this article
Personnel and amount used only for drug discovery and DDS reviewUndetermined / FutureNot specified in Source 2. This article does not estimate
Chapter 6 Prospects ()ulation 1 item / Undetermined 2 item)Interpre of this paper from the description of source 8 and 9

Last Updated:September 26, 2026/Troy Technical
This document is based on the official website, annual activity report, scientific guidelines, EPAR, and ICH. This is an interpretation that reads from primary information. This article does not recommend certain medicines.

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