Centralised Procedure in Europe: A Primer for US-Based Pharmaceutical Companies

The pharmaceutical industry is a vast landscape of innovation, regulatory standards, and international processes. As US-based pharmaceutical companies expand their operations and look to tap into the European market, it’s imperative to understand the regulatory environment. One of the most pivotal regulatory pathways for gaining market access in Europe is the Centralised Procedure. Here’s a comprehensive guide to get you started.

1. What is the Centralised Procedure (CP)?

The Centralised Procedure is a single application process through which a company can obtain a marketing authorization that is valid across all member states of the European Union (EU), as well as in the European Economic Area (EEA) countries: Norway, Iceland, and Liechtenstein.

The European Medicines Agency (EMA) is responsible for overseeing the Centralised Procedure, ensuring that medicines meet rigorous standards of safety, efficacy, and quality.

2. Why opt for the Centralised Procedure?

• Uniformity: A single application under CP eliminates the need for multiple national applications.
• Efficiency: Faster market access to all EU and EEA member states.
• Consistency: One assessment ensures similar standards and interpretations across countries.

3. Who Should Use the Centralised Procedure?

The Centralised Procedure is mandatory for:

• Biotechnological products.
• Orphan medicinal products (intended for rare diseases).
• Medicines for human use that contain a new active substance for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes, autoimmune and other immune dysfunctions, and viral diseases.
• Products derived from certain biotechnological processes.

However, other pharmaceutical companies can also opt for the Centralised Procedure, especially if they anticipate a wider European market.

4. The Centralised Procedure Process:

1. Pre-submission activities: Includes dialogue with EMA to get guidance on the application.
2. Submission of Application: Comprises the dossier with all the necessary data on the medicinal product.
3. Scientific Evaluation: Conducted by the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for Veterinary Use (CVMP). This lasts 210 days excluding the time it takes for the company to answer questions.
4. Opinion by CHMP/CVMP: Within 15 days of concluding the evaluation, an opinion is provided to the European Commission.
5. Decision by European Commission: Within 67 days of the CHMP/CVMP opinion, the Commission issues its decision.

5. After Approval:

Post-approval, the pharmaceutical company can market its product in all EU and EEA countries. Still, they must adhere to pharmacovigilance, post-marketing surveillance, and renewal requirements.

6. Transition from US to European Regulatory Framework:

For US-based companies, there are key differences between the FDA and EMA regulations and procedures. However, many principles of clinical development, safety, efficacy, and quality assessment are shared. Partnering with European regulatory consultants or having a dedicated European regulatory affairs team can smoothen the transition.

Conclusion:

The Centralised Procedure offers a streamlined pathway for US-based pharmaceutical companies to introduce their products to the European market. By understanding its nuances, companies can not only expand their reach but also foster innovation and improve patient access to new and effective treatments across Europe.