European Centralized Procedure Underutilized, Say Industry Experts

As Changes Are Recommended To EU Pharmaceutical Legislation

 
• By Akriti Seth
  
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The key advantages of the European centralized procedure, its usage by generics and biosimilars developers and the EU Pharmaceutical strategy and legislation were discussed at length in a recent webinar hosted by Medicines for Europe.

Advantages
Industry acknowledges the many plus points of the centralized procedure • Source: Alamy

Jonathan Rousell, vice president of regulatory affairs for Europe and International markets at Teva, has insisted that it is advantageous for generics and biosimilars developers to use Europe’s centralized procedure for marketing authorizations, while discussing the topic of “upgrading marketing authorization procedures to increase availability and tackle shortages and supply chain resilience” at a recent Medicines for Europe webinar.

“The centralized procedure is very much an attractive option for some companies and for specific products,” said Rousell. “It's currently...

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