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Common European Submission Platform: Pilot The Common European Submission platform (ESP) is an initiative under the remit of the Heads of Medicines Agency (MA), a group of Agencies and Industry Representatives

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What is common european submission platform?

Common European Submission Platform (CESP) is an online platform designed to facilitate the electronic submission of regulatory information for medicinal products to the European Medicines Agency (EMA).

Who is required to file common european submission platform?

Pharmaceutical companies and other stakeholders involved in the development, approval, and post-approval activities of medicinal products are required to file the Common European Submission Platform (CESP).

How to fill out common european submission platform?

To fill out the Common European Submission Platform (CESP), users need to create an account on the platform, provide the required information and documentation as per the specific submission requirements, and submit the application electronically through the platform.

What is the purpose of common european submission platform?

The purpose of the Common European Submission Platform (CESP) is to streamline and harmonize the submission process for regulatory information related to medicinal products across European Union member states. It aims to improve efficiency, transparency, and collaboration among stakeholders.

What information must be reported on common european submission platform?

The specific information that must be reported on the Common European Submission Platform (CESP) depends on the type of submission. Generally, it includes product data, clinical trial data, quality data, safety data, and other relevant regulatory information.

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