Unlike most countries that adopt a single national regulatory system, the European Union has established a highly institutionalized and regionally coordinated framework for drug registration. As one of the most complex and mature regulatory systems in the world, the EU has implemented four complementary and relatively independent marketing authorization procedures to ensure harmonization among its member states. These include: Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP) and National Procedure (NP).
The EU’s registration system differs significantly from the typical "single regulatory authority + nationwide approval" model seen in other countries. Its multi-path, multi-country coordinated approach places higher demands on applicants in terms of regulatory compliance and strategic planning. This tiered system reflects the EU’s commitment to internal market integration, while offering pharmaceutical companies flexible registration options tailored to different product types, therapeutic areas, and market strategies.
This article focuses on the Centralized Procedure (CP), which is coordinated by the European Medicines Agency (EMA) and is intended for innovative medicines, high-risk products, or treatments for serious diseases. Once approved, a CP-authorized product is eligible for marketing across the entire EU, including certain countries in the European Economic Area (EEA), offering the distinct advantage of "one review, EU-wide access." It is the most representative and widely applicable registration pathway within the EU regulatory system.
Application Scenario of CP:
Application Scenario | Type of Medicinal Product | Specific Requirements / Scope |
Mandatory | Human Medicines | - Contains new active substances and intended to treat any of the following diseases: ▶ Human immunodeficiency virus (HIV) / Acquired immunodeficiency syndrome (AIDS) ▶ Cancer, diabetes, neurodegenerative disorders, autoimmune diseases and other immune dysfunctions, viral diseases - Medicines produced using biotechnological processes (e.g., gene-engineered drugs) - Advanced therapy medicinal products (e.g., gene therapy, somatic cell therapy, tissue-engineered medicines) - Orphan medicines (for rare disease treatment) |
Veterinary Medicines | - Veterinary medicines used as growth or yield promoters |
Voluntary | Other Medicines | - Eligible to voluntarily apply for CP if one or more of the following conditions are met: - Contains a new active substance, but the indication does not fall under the mandatory scope - Has significant therapeutic, scientific or technical innovation - The product is of interest for public or animal health at the EU level |
Core process of CP:
1. Application Submission:
The applicant submits a single marketing authorization application to the EMA, covering the entire European Union.
2. Assessment Bodies:
Human medicines are evaluated by the CHMP (Committee for Medicinal Products for Human Use); veterinary medicines are evaluated by the CVMP (Committee for Medicinal Products for Veterinary Use).
3. Scientific Evaluation and Opinion:
The CP evaluation timeline is shown in the table below. For detailed information, please refer to the EMA official website.
Stage | Timeline | Key actions |
Preliminary evaluation | 0–120 days | - The applicant submits the application, and EMA initiates the evaluation. - CHMP drafts the report and identifies issues. - PRAC assesses the Risk Management Plan (RMP). - An initial list of questions is formed. |
First clock stop | Around 3 months | - The applicant responds to the initial questions and updates the RMP. - Up to 3 months, requires CHMP approval. |
Further assessment | 121–180 days | - CHMP evaluates the responses, updates the report, and may issue a list of outstanding questions. |
Second clock stop | Around 1 month | - The applicant responds to the outstanding questions and may request an oral explanation. - Maximum duration: 1 month. |
Final evaluation and approval | 181–210 days | - The applicant responds to objections (if any). - Consultation with external experts. - Final review by CHMP and PRAC, forming the marketing authorization recommendation. - Final opinion issued by Day 210. |
*For medicines of major public health interest, the EMA offers accelerated assessment, shortening the evaluation timeline from 210 days to 150 days.
4. European Commission Decision:
The statutory authorization authority, the European Commission (EC), holds the final approval power and must make a legally binding decision within 67 days after receiving the EMA’s opinion.
Outcomes:
Approval: The medicine can be marketed in all EU member states and European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway).
Rejection: The medicine is not allowed to be marketed within the EU.
5. Post-Marketing Surveillance:
Safety Monitoring: The EMA and member states continuously monitor medicine safety through the Pharmacovigilance Risk Assessment Committee (PRAC), including evaluating risk management measures, collecting suspected adverse reaction reports from patients and healthcare professionals, and reviewing benefit-risk balance reports submitted by pharmaceutical companies.
Urgent Measures: If safety issues are identified, the EU referral procedure can be initiated to quickly implement measures such as revising the product information, restricting use, or suspending marketing authorization.
6. 6.e-CTD Submission Pathway:
All CP e-CTD sequences must be submitted via the EMA e-submission gateway.
The CP registration procedure offers the institutional advantage of “one evaluation, valid throughout Europe,” but this also means higher technical barriers, more complex evaluation processes, and stricter compliance requirements. How to accurately understand the latest requirements of the EMA and CVMP? How to prepare high-quality submission dossiers and efficiently respond to reviews? These are critical challenges that many companies face when entering the European market.
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In the future, we will introduce the other three EU registration procedures: DCP, MRP, and NP. Subscribe to us to learn more.
