Mastering an EU drug product launch: strategies for overcoming regulatory complexities

Navigating the EU market's regulatory landscape is a daunting task for biopharma companies aiming to launch new drug products. With 27 member states, each with its own local Health Agencies and regulatory requirements, thorough preparation and strategic planning are essential for success.

Key regulatory submission strategies

To market a medicinal product in any EU member state, companies must obtain a marketing authorization (MA). There are four main regulatory pathways to consider:

Centralized Procedure (CP): A single MA application that, once approved, is valid across all EU Member States. Ideal for products derived from biotechnology processes, treatments for widespread diseases, advanced therapy medicines, and orphan drugs.
Decentralized Procedure (DCP): Allows applicants to choose the member states they want to access, and which country's regulatory authority will lead the assessment.
Mutual Recognition Procedure (MRP): Suitable for products already authorized in one member state, allowing recognition by other member states.
National Procedure (NP): Permits access to a single country without needing consensus from multiple member states.

The choice of regulatory procedure depends on the medicinal product, launch strategy, target market, and commercial objectives. For instance, products with significant therapeutic, scientific, or technical innovation may benefit from the centralized procedure.

Important regulatory considerations for a successful launch

Local representation requirements vary by country and activity. Regulatory affairs representatives handle local regulatory actions, while scientific services ensure compliance with advertising and educational materials. Pharmacovigilance (PV) representatives maintain the EudraVigilance database and ensure local compliance.

National medicinal databases are managed by state authorities in most EU countries. The Marketing Authorization Holder (MAH) is responsible for updating these databases with product information. Requirements for national identification numbers and serialization also vary across countries.

Finalizing regulatory artwork and shared pack strategy is crucial for commercial and supply chain efficiency. Considerations include outer packaging layout, labeling text, blue-box requirements, serialization, and Braille format.

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Navigating the complexities of the European market requires a strategic approach and thorough understanding of regulatory requirements. IQVIA's successful EU launch strategy involves collaboration with global and local stakeholders, leveraging regulatory intelligence services and best practice guidelines. By strategically navigating regulatory complexities, companies can minimize market entry delays and maintain compliance, ensuring a successful drug product launch in the European market.

For a more detailed guide on mastering the European market's regulatory landscape, download and read our comprehensive white paper, Navigating the European Market’s Regulatory Complexities.

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Key regulatory submission strategies

Important regulatory considerations for a successful launch

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