Frost & Sullivan Research Service   Published: 22 Dec 2008
Drug Approval Process in Europe - An Outlook
   Research Overview

This Frost & Sullivan research service titled Drug Approval Process in Europe - An Outlook provides an insight into the mutual recognition procedure, centralised procedure, price controls, and parallel trading. In this research, Frost & Sullivan's expert analysts thoroughly examine the European Union (EU) regulatory processes, comparing the EU and the U.S.A.’s drug approval processes, price controls and parallel trading, biosimilars approval, and bi-lateral and tri-lateral integration.

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Market Overview

Transatlantic Regulatory Integration of Drug Approval Process Fundamental for the Success of the Global Pharmaceutical Industry

The diverse regulatory environment across the EU and the United States needs to be integrated to overcome challenges during drug launches. Different regulations impact the drug launches as less-price controlled markets witness quicker launches, while it takes longer in regulated markets. The pharmaceutical industry along with the regulatory agencies has been working closely with the The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to develop a standard set of regulatory process for Europe, the United States, and Japan. “The future of the pharmaceutical industry lies in the globalization of the drug approval processes,” notes the analyst of this research. “Pan-European integration and transatlantic coordination on the regulatory front is high on the agenda for Europe, Middle East and Africa (EMEA) and the Food & Drug Administration in the United States.” Several companies are venturing into manufacturing biosimilars, since biologics are on the verge of patent expiry. This has led to the formation of new regulatory pathways for biosimilar approvals in the EU. The EU has pioneered the creation of a regulatory pathway for biosimilars in Europe.

However, the gap between European regulatory authorities and national pricing authorities needs to be bridged. Although centralised procedures authorise the sale of drugs in all member states, pharmaceutical companies still have to file for price or reimbursement approvals. Some countries have distinct methods of drug price approvals and their processes are not always transparent, making it difficult for drug manufacturers to do business in Europe. “The unfavourable regulatory environment, varying price controls across member states, and parallel trading hinder the growth of the pharmaceutical industry in Europe,” explains the analyst. “Due to the varied price regulations across EU, research-intensive firms undertake R&D activities in less price controlled markets.”

EU-wide synchronisation will make the approval process faster, reducing delays in drug launches. Transatlantic co-ordination will also aid in streamlining regulatory costs. Transatlantic regulatory convergence will have immense benefits such as faster technology transfer, regulating approval of unsafe drugs, and patent law harmonisation. “EMEA should encourage frequent dialogues with patient and industry representatives to ensure a transparent approval process,” concludes the analyst. “Such interaction will also aid in redefining the clinical trial design and streamline the drug approval process.”

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  Table Of Contents

   List of Figures

Chapter 3

  • Drug Approval Process: Top Industry Challenges (Europe), 2008

Chapter 4

  • Drug Approval Process: National Competent Authorities (Europe), 2008
  • Drug Approval Process: Comparing the Drug Approval Systems in Europe and the United States (Europe), 2008
  • Drug Approval Process: Comparing the Biotech Industries in Europe and the
    United States (Europe), 2008

Chapter 5

  • Drug Approval Process: Methods Used for Price Comparison (Europe), 2008
  • Drug Approval Process: List of Countries Based on Drug Pricing (Europe), 2008
  • Drug Approval Process: National Pharmaceutical Pricing Regulation (Europe), 2008

Chapter 8

  • Decision Support Database: Number of Biotech Companies (World), 1999-2006
  • Decision Support Database: Number of Biotechnology Patents Filed at/Granted by the European
  • Patent Office (EPO) (World), 1996-2000
  • Decision Support Database: Number of Biotech Patents granted by USA Patent and Trademark Office (World), 1996-2000
  • Decision Support Database: Government R&D Investment in Biotechnology in Million USD (World), 1999-2006
  • Decision Support Database: Private Investment in Biotechnology in Million USD (World), 1999-2006

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