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Market Access in Europe: Navigating Regulations for Orphan Drug Launches

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"Market Access in Europe: Navigating Regulations for Orphan Drug Launches"

Learn how to navigate EU regulations, secure orphan designation, negotiate with EU countries, and succeed in introducing rare disease medicines in the European market as a US biotech firm.

US biotech firms looking to enter the European market can very quickly become overwhelmed with the number of regulations and procedures required to approve and roll out new rare disease medicines.

Approval not only has to be sought on a Europe-wide level, but each individual country also has its own requirements.

For any biotech company looking to gain a foothold in the European market, an understanding of the rare disease medicine regulatory system is essential for success.

To help you to navigate the complexities of EU regulations and distribution, our guide covers these key topics to help you thrive in the European market:

  • Requirements from European Medicines Agency (EMA)
  • The process of gaining ‘orphan designation’
  • Negotiating with individual EU countries
  • The importance of early phase engagement
  • Product packaging issues


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