In our previous article, we introduced the application of the Centralised Procedure (CP) in the European drug registration process. This article presents a comprehensive guide to the Decentralised Procedure (DCP).
The Decentralised Procedure (DCP) applies to medicinal products that have not yet received marketing authorisation in any EU Member State. This pathway allows applicants to simultaneously submit applications to multiple EU Member States without relying on a central authority. A designated Reference Member State (RMS) leads the scientific evaluation, while the Concerned Member States (CMSs) review the results and work towards a consensus.
The greatest advantage of DCP lies in its ability to coordinate resources across multiple countries, thereby improving review efficiency. It is especially suitable for generic drugs, biosimilars, and multinational pharmaceutical companies looking to launch products across several EU countries simultaneously.
Compared to the CP, the DCP process is generally more flexible and adaptable in terms of product types, innovation levels, and market entry strategies. However, applicants must still strictly adhere to the regulatory requirements of each participating country and ensure the consistency and compliance of submission materials. The national marketing authorisations obtained through DCP are legally equivalent to those granted via the CP but are issued by the national competent authorities of the Member States rather than the European Commission.
Applicable Scenarios:
For medicinal products that do not fall under the scope of the EMA’s Centralised Procedure, applicants may seek marketing authorisation simultaneously in several EU Member States where the product is not yet authorised, without requiring prior approval in any country.
Core Steps of the DCP Process:
1. Initial Submission:
Submit eCTD sequences containing both the common content and country-specific information to all participating Member States. Each country must receive a separate Module 1 envelope, and the procedure type must be indicated as “decentralised.”
2. Technical Validation:
If any technical defects are identified in the submission, the applicant must promptly resubmit a corrected version with the same sequence number.
3. Content Validation and Evaluation:
During validation, updates are communicated via email. The final corrected eCTD sequence must be submitted as a “validation-response”. All responses must be submitted in a universal format—country-specific responses are not allowed.
A timeline of the DCP assessment process is provided in the table below. For more details, please refer to the HMA official website.
Phase | Timeline | Key actions | Participants |
Pre-procedural Phase | Before Day -14 | Applicant contacts RMS to obtain procedure number | Applicant、RMS |
Day -14 | Submission of application dossier; technical validation by RMS/CMSs within 14 days | Applicant、RMS、CMSs |
Assessment Phase I | Day 0 | RMS officially starts the procedure and notifies CMSs | RMS、CMSs |
Day 70 | RMS issues Preliminary Assessment Report (PrAR) to CMSs and applicant | RMS、CMSs、Applicant |
Day 70–100 | CMSs submit comments; RMS coordinates feedback | RMS、CMSs、Applicant |
Clock Stop | After Day 100 | Applicant submits responses within 3 months (extendable) | Applicant、RMS |
Assessment Phase II | Day 120（restart） | RMS submits final Draft Assessment Report (DAR) and draft product documents | RMS、CMSs、Applicant |
Day 145 | CMSs provide final comments | RMS、CMSs、Applicant |
Day 150–210 | - If consensus is reached: procedure ends and moves to national approval
- If no consensus: referral to CMDh | RMS、CMSs、Applicant |
CMDh Referral Phase | After Day 210 | CMDh arbitrates disagreements (by Day 270 at latest); CHMP involvement if needed | CMDh、CHMP |
Post-procedure | Within 30 days | National marketing authorisations issued (subject to translation submission) | RMS、CMSs |
4. Post-Procedure Steps:
Once the procedure is completed, subsequent lifecycle management is carried out through the Mutual Recognition Procedure (MRP), and the envelope procedure type must be updated to “mutual-recognition.”
5. eCTD Submission Route:
All eCTD sequences for DCP must be submitted via CESP (Common European Submission Portal).
As a professional institution specializing in global drug registration and technical support services, Beijing BrilliantMed Pharma Tech Co., Ltd. has conducted in-depth research on the registration pathways of various countries/regions worldwide, including the European Union. It is committed to providing pharmaceutical enterprises with one-stop registration solutions:
- Strategy design (such as recommendations for selecting member states in EU registration).
- Full-process review of registration dossier content and optimization of electronic format.
- eCTD publishing and electronic submission via Gateway (e.g., EMA Gateway/CESP).
- Communication and coordination with official Health Authorities (e.g., EMA/RMS/CMS).
- Preparation of technical responses and lifecycle management support.
In the next article, we will introduce the remaining two EU registration procedures: MRP and NP. Subscribe to us to learn more.
