Drug Discovery Units Need to Undergo Stringent Government Approval Procedures to Witness Growth

The European drug discovery industry’s key concerns lie in the continuously mounting cost pressures, shorter product life cycles and various issues relating to clinical trial data management. Notwithstanding the best efforts of pharmaceutical manufacturers, drug labelling remains an obstacle in obtaining regulatory approvals for pharma and biotech companies. It involves printing a wide range of information sought by investigators, subjects and pharmaceutical companies. Moreover, as participant enterprises are required to undergo strict government approval procedures, risks such as delays, non-approval as well as loss of time and money pose problems, thus increasing their dependence on the follow-up procedures.

This Frost & Sullivan research service is a strategic analysis of the regulatory hurdles prevalent in the European drug discovery markets. It provides an overview of the European Community directives along with the regulatory environment prevalent in the drug discovery markets. Further, it also investigates factors affecting the level of competition as well as identifies future trends in demand and investment in the industry.

Market Unification Could Offer Substantial Opportunities to European Pharma Enterprises

Continuous efforts by the members of the European Union (EU) to present themselves as a single market entity offer vast scope for the drug discovery and pharmaceutical industries. Increasingly, pharmaceutical companies in Europe are becoming accustomed to the new regulatory procedures, especially the centralised and mutual recognition ones. These regulatory processes started gaining momentum in 1998, when the transition period expired, and since then, they have widely been accepted as pharma registration models in the EU.

"In general, regulatory guidelines pertaining to drug discovery aim to maintain, update and simplify EU pharma legislations, wherever feasible, along with drafting new ones," notes the analyst of this research service. "They also aid national-level marketing authorization decisions in gaining recognition, ensure conformity with the appropriate standards pertaining to consumer protection and provide guidance on the implementation of pharma legislations within the EU."

Proactive Policies in the Pharmaceutical Industry Propel the European Drug Discovery Markets

Enterprises in the drug discovery industry are under constant pressure to provide enhanced value on their existing products, which in turn, increases their cost. Presently, a key concern for these enterprises is that less than 1.0 per cent of the drugs in the discovery and development stages reach the marketplace. Often, the failure rates are high and the non-viability of the whole course becomes apparent during the latter stages of drug development, after having already devoured substantial time and resources. Hence, companies need to devise tactics constantly to tackle concerns such as costly bottlenecks, inefficiencies and unacceptably huge failure rates. They also have to create quicker and more efficient processes to develop more market-feasible discoveries.

"Overall, factors such as more number of strict regulations, conscious compliance with good manufacturing practices (GMP) and improved clear-cut legislations for an efficient and competitive environment are expected to act as crucial drivers for the drug discovery markets in western and eastern Europe," observes the analyst.

1. Regulatory Hurdles in European Drug Discovery
        1. Overview
                1. Overview
        2. Research Scope & Methodology
                1. Research Scope & Methodology
        3. Key Definitions and Abbreviations
                1. Key Definitions and Abbreviations
        4. Introduction
                1. Introduction
        5. Overview of EC Directives
                1. Overview of EC Directives
        6. European Authorisation Procedure
                1. European Authorisation Procedure
        7. Regulatory Policy
                1. Regulatory Policy
        8. State Members of the European Union
                1. State Members of the European Union
        9. Applicants and Other European Countries
                1. Applicants and Other European Countries
        10. Regulatory Challenges
                1. Regulatory Challenges
        11. Regulatory Hurdles in Austrian Drug Discovery
                1. Regulatory Hurdles in Austrian Drug Discovery
        12. Regulatory Hurdles in Belgium Drug Discovery
                1. Regulatory Hurdles in Belgium Drug Discovery
        13. Regulatory Hurdles in Czech Republic Drug Discovery
                1. Regulatory Hurdles in Czech Republic Drug Discovery
        14. Regulatory Hurdles in Danish Drug Discovery
                1. Regulatory Hurdles in Danish Drug Discovery
        15. Regulatory Hurdles in Finnish Drug Discovery
                1. Regulatory Hurdles in Finnish Drug Discovery
        16. Regulatory Hurdles in French Drug Discovery
                1. Regulatory Hurdles in French Drug Discovery
        17. Regulatory Hurdles in German Drug Discovery
                1. Regulatory Hurdles in German Drug Discovery
        18. Regulatory Hurdles in Greek Drug Discovery
                1. Regulatory Hurdles in Greek Drug Discovery
        19. Regulatory Hurdles in Hungarian Drug Discovery
                1. Regulatory Hurdles in Hungarian Drug Discovery
        20. Regulatory Hurdles in Italian Drug Discovery
                1. Regulatory Hurdles in Italian Drug Discovery
        21. Regulatory Hurdles in Polish Drug Discovery
                1. Regulatory Hurdles in Polish Drug Discovery
        22. Regulatory Hurdles in Portuguese Drug Discovery
                1. Regulatory Hurdles in Portuguese Drug Discovery
        23. Regulatory Hurdles in Slovakian Drug Discovery
                1. Regulatory Hurdles in Slovakian Drug Discovery
        24. Regulatory Hurdles in Spanish Drug Discovery
                1. Regulatory Hurdles in Spanish Drug Discovery
        25. Regulatory Hurdles in Swedish Drug Discovery
                1. Regulatory Hurdles in Swedish Drug Discovery
        26. Regulatory Hurdles in the United Kingdom Drug Discovery
                1. Regulatory Hurdles in the United Kingdom Drug Discovery
        27. Conclusion
                1. The Future
        28. Decision Support Databases
                1. Decision Support Databases