The full form of DCP in the pharmaceutical context is Decentralized Procedure.
Decentralized Procedure (DCP) Explained
The Decentralized Procedure (DCP) is a regulatory pathway used in the European Union (EU) to obtain marketing authorization for medicinal products that are not intended to be authorized through the centralized procedure (managed by the European Medicines Agency, EMA). This procedure is used when a company wants to market a drug in multiple EU member states simultaneously, but the drug has not yet been approved in any of them.
Key Aspects of the Decentralized Procedure:
- Mutual Recognition: DCP leverages the principle of mutual recognition among EU member states. It starts with one member state (the Reference Member State or RMS) conducting a comprehensive assessment of the submitted application dossier.
- Reference Member State (RMS): The RMS evaluates the quality, safety, and efficacy of the medicinal product.
- Concerned Member States (CMS): The applicant identifies the other member states (CMS) where they intend to market the product. These CMS then evaluate the RMS's assessment report.
- Harmonized Assessment: The goal is to achieve a harmonized assessment and approval of the medicinal product across all involved member states.
- Timeline: The DCP has a defined timeline, typically taking around 210 days, excluding clock-stops (periods where the process is paused, typically for the applicant to address questions from the regulatory authorities).
- Potential for Disagreement: If a CMS raises a significant objection related to a potential serious risk to public health, the issue is referred to the Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) for resolution. If the CMDh cannot reach a consensus, the matter is escalated to the EMA's Committee for Medicinal Products for Human Use (CHMP) for arbitration.
In summary, the Decentralized Procedure provides a mechanism for companies to gain market access for their pharmaceutical products across multiple European markets through a coordinated assessment process.
