Pharmaceutical Regulatory Industry

Published - Jan 2006| Analyst - Shalini Shahani Dewan| Code - PHM047A
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Report Highlights

  • The total number of new drugs approved by the FDA and EMEA dropped to 121 in 2005. Approvals will increase to 201 by 2010, at an AAGR of 10.7%.
  • There were about 1,934 recalls in 2003 (including all batch recalls and product recalls), and the rate increased to 2,072 in 2005. It is expected to increase at an AAGR of 5.1% to reach 2,616 by 2010.
  • The most recalls in 2005 were seen in pain management, anti-inflammatory, anesthetics and antiallergic drugs.
  • Spending in the regulatory and surveillance industry is expected to rise at an AAGR of 10% to reach $265 billion by 2010, with the emphasis on oncology, cardiovascular, hormonal, contraceptive and mental disorder drug markets.


Since Congress enacted the Pure Food and Drugs Act of 1906, the regulatory agency spawned by this law, the U.S. Food and Drug Administration (FDA), has come to directly regulate between one-fifth and one-quarter of U.S. gross domestic product (GDP). It possesses significant power over product entry, the ways in which food and drugs are marketed to consumers, and the manufacturing practices of food and drug firms.

Drug regulatory agencies play a key role in ensuring that medicines available for use are safe and effective. Recent efforts to improve access to medicines in the developing world have led to a focus not only on prices and international barriers to trade, but on national drug regulatory agencies (DRAs) and their role in registering drugs for use.

This comprehensive report covers current and potential aspects of the regulatory industry in the pharmaceutical . It provides a complete analysis of the new drugs being approved, the recalls/withdrawals experienced by the pharmaceutical industry, and spending in the regulatory sector.

The study explores the past, present and future strategies and policies used in regulatory compliance for drug development and postmarketing issues. Also included are product forecasts for new drugs and recalls, as well as the regulations, types of regulatory agencies and the approval process for drug products.


The report contains:


  • Coverage of regulatory environments worldwide
  • Analyses of each market by drug category
  • Discussions of the process and time involved in approval - NDA, BLA, EMEA
  • Postmarketing issues
  • Market trends with historical perspectives
  • Five-year market projections for new approvals and recalls
  • Drug safety spending data
  • Company profiles.



A comprehensive literature search was conducted. The literature included technical newsletters and journals, as well as many other sources. The data were collected through interviews and correspondence with various analytical/chemical/ pharmaceutical experts. Projections were based on estimates such as the current number of approvals or recalls or surveillance changes, likely spending for each drug product, rates of consumption and market trends.


BCC surveyed many companies to obtain data for this study. Included were manufacturers, researchers and the end users of pharmaceuticals. A lot of data was obtained from regulatory agencies as well. We spoke with officials and physicians, consulted newsletters, company literature, product literature, a host of technical articles, journals, indexes, and abstracts. Exhaustive investigations of databases by key terminology were performed. In addition, we compiled data from current financial and trade information and government sources.


Shalini Shahani holds a master's degree in pharmaceutical chemistry. She has covered many research topics, including Studies on Compounds of Potential Pharmaceutical Interest, from Ibuprofen to 2-Naphthyl Acetic Acid. Shahani was awarded a Gold Medal by the prime minister of India for her work and has worked with top companies in India and in the U.S. Some of her other reports with BCC are Reagents of Chromatography, Spectroscopy: An Enduring Market, Advanced Drug Delivery Systems, Orthopedic Drugs, Implants and Devices and Imaging Reagents.

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