Regulatory Approval Pathways: EU vs US

Drug Authorization Procedures in the EU 

Sponsors have several options when seeking market approval for a new drug in Europe: a national authorization procedure, a decentralized procedure, a mutual recognition procedure and a centralized procedure. Depending on a product’s eligibility, each of these authorization routes offers different advantages and disadvantages to the sponsor, and these should be considered when setting up the market strategy of a product.

National Procedure

This procedure is used whenever a company wants to commercialize a product in only one EU Member State.

The National procedure is specific to each country. That is, each country within the EU has its own procedures for authorizing a marketing application for a new drug. Sponsors can find information regarding the requirements and procedure of each country on the websites of the regulatory agencies.

ADVANTAGES of National Procedure

There are some advantages in submitting…