Drug Approval Process in Europe - An Outlook

 

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This research deals with the drug approval process in Europe by focussing on the various marketing authorisation procedures, price controls and parallel trading. A snapshot of the biosimilars approval process is also provided along with the key strategic recommendations.

Table of Contents

Drug Approval Process in Europe - An Outlook, Executive SummaryExecutive Summary of the Drug Approval Process in EuropeOverview of the European Drug Approval ProcessDrug Approval Process in Europe - An Outlook, Research MethodologyResearch Methodology for Drug Approval Process in EuropeThe MethodologyScope and ObjectivesDrug Approval Process in Europe - An Outlook, Regulatory ChallengesMajor Industry ChallengesIntroductionRegulatory Challenges in the European UnionDrug Approval Process in Europe - An Outlook, Overview of the Marketing Authorisation in European UnionMarketing Authorisation ProceduresMarketing Authorisation Procedures in EuropeComparing the Regulatory Systems in Europe and the United StatesDrug Approval Process in Europe - An Outlook, Price Control and Parallel TradingOverview of the Price Control and Parallel Trading in EuropeAnalysis of Price Control and Parallel TradingDrug Approval Process in Europe - An Outlook, Regulatory Approval for BiosimilarsApproval Process for BiosimilarsBiosimilars in EuropeDrug Approval Process in Europe - An Outlook, Strategic RecommendationsKey FindingsRecommendations for the European Drug Approval ProcessDrug Approval Process in Europe - An Outlook, AppendixDecision Support Database Number of Biotech CompaniesNumber of Biotetchnology Patents-European Patents OfficeNumber of Biotechnology Patents - USA Patents and Trade Mark OfficeGovernment R&D Investment in BiotechnologyPrivate Investment in Biotechnology




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