DCP submission refers to the Decentralised Procedure (DCP), a regulatory submission process used in the European Union (EU) for marketing authorisation of pharmaceutical products. It's a system where a company applies for marketing authorisation in multiple EU member states simultaneously, based on an initial assessment done by a chosen Reference Member State (RMS).
Here's a breakdown:
- EU Procedure Type: DCP is a specific type of marketing authorisation procedure within the EU.
- Decentralised Approach: Unlike the Centralised Procedure (where the European Medicines Agency (EMA) grants a single marketing authorisation valid across the entire EU), DCP involves national competent authorities.
- Reference Member State (RMS): The applicant selects one EU member state as the RMS. The RMS assesses the application dossier and prepares an assessment report.
- Concerned Member States (CMS): These are the other EU member states where the applicant wants to market the product. They review the RMS's assessment report.
- Concurrent Review: All CMS review the application and the RMS's assessment report concurrently.
- Mutual Recognition: The goal is for the CMS to agree with the RMS's assessment and grant national marketing authorisations based on that assessment.
Essentially, DCP streamlines the process for obtaining marketing authorisations in multiple EU countries by leveraging a single, comprehensive assessment report.
In simpler terms: Imagine applying for a building permit in multiple towns at once. One town takes the lead in reviewing your blueprints. If the other towns trust the lead town's assessment, they're more likely to approve your permit quickly. That's similar to how DCP works for medicines in the EU.
Key Aspects of DCP Submissions:
- Choice of RMS: Selecting the right RMS is crucial. Factors to consider include the RMS's expertise in the therapeutic area, regulatory efficiency, and language.
- Comprehensive Dossier: The application dossier must be complete, well-organized, and compliant with EU regulatory requirements. This typically follows the Common Technical Document (CTD) format.
- Timelines: DCP has defined timelines for each stage of the process, from submission to granting of marketing authorisations.
- Potential for Disagreement: If CMS have concerns about the assessment report, they can raise objections. The RMS and the applicant then work to address these concerns. If the concerns cannot be resolved, the matter may be referred to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).
- Suitable for Products Not Yet Authorised: DCP is typically used for products that haven't already been approved in any EU member state (unlike the Mutual Recognition Procedure, which is for products already authorised in one EU country).
Why Use DCP?
- Efficient: Allows simultaneous application in multiple EU countries.
- Cost-effective: Reduces duplication of effort compared to submitting separate applications to each member state.
- Market Access: Facilitates quicker access to multiple EU markets.
