Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998

Rawson, Nigel S.B.; Rawson, N S
February 2000
CMAJ: Canadian Medical Association Journal;2/22/2000, Vol. 162 Issue 4, p501
Academic Journal
journal article
Background: The timeliness with which national regulatory agencies approve new drugs for marketing affects health care professionals and patients. An unnecessarily long approval process delays access to new medications that may improve patients' health status. The author compared drug approval times in Canada, Australia, Sweden, the United Kingdom and the United States. Methods: Application and approval dates of new chemical or biological substances (excluding diagnostic products, and new salts, esters, dosage forms and combinations of previously approved substances) approved for marketing in the 5 countries from January 1996 to December 1998 were requested from the relevant pharmaceutical companies. Data on new drug approvals during the study period were also obtained from the national drug regulatory agencies in Canada, Australia and Sweden and from publications of the US Food and Drug Administration. Results: A total of 219 new drugs were identified as being approved in at least one of the countries during the study period: 23 (10.5%) in all 5 countries, 23 (10.5%) in 4, 27 (12.3%) in 3, 42 (19.2%) in 2, and 104 (47.5%) in 1 country. By individual nation, 97 drugs were identified as being approved in Canada, 94 in Australia, 107 in Sweden, 55 in the UK and 123 in the US. Approval times in Canada and Australia were similar (medians 518 and 526 days respectively), but both countries had significantly longer approval times than Sweden (median 371 days), the UK (median 308 days) and the US (median 369 days). This pattern was consistent across all 3 years and for the 23 new drugs approved in all 5 countries during the 3-year period. Median approval times in Canada were similar in all of the reviewing divisions of Health Canada's Therapeutic Product Program (539-574 days) except the Central Nervous System Division (428 days) and the Bureau of Biologics and Radiopharmaceuticals (698 days). Interpretation: Median drug approval times during 1996-1998 decreased by varying amounts from the 1995 values in all 5 countries. However, the median approval time in Canada continues to be significantly longer than the times achieved in Sweden, the UK and the US, and it remains considerably longer than Canada's own target of 355 days for all new drugs.


Related Articles

  • Rare incentives. Hughes, Bethan // Nature Reviews Drug Discovery;Mar2008, Vol. 7 Issue 3, p190 

    The article investigates the incentives and the challenges for orphan drug development in the U.S. and the European Union (EU). The incentives include tax credits for the cost of clinical research and assistance in clinical-study designs in the U.S., and protocol assistance to optimize...

  • Drug reimport won't save much, study finds.  // Drug Topics;5/17/2004, Vol. 148 Issue 10, p10 

    Reports that according to an issue brief from the U.S. Congressional Budget Office, allowing reimportation of U.S.-made medications would reduce drug spending by only about one percent.

  • The problem of orphan drugs: Incentives to make orphan drugs should be proportionate to their benefits. Ferner, Robin E.; Hughes, Dyfrig A. // BMJ: British Medical Journal (Overseas & Retired Doctors Edition;11/20/2010, Vol. 341 Issue 7782, p1059 

    The authors ponder on the problems surrounding orphan drugs, or the drugs developed for life threatening or chronically debilitating rare disorders. They cite the aim of the orphan drug legislation in the U.S. and Europe, along with the unintended consequences of such legislation. They explain...

  • Abstracts of China's Laws and Regulations Related to Pharmaceutical Sector.  // China Chemical Reporter;1/26/2009, Vol. 20 Issue 3, p7 

    The article provides an overview of China's pharmaceutical policy. According to the Drug Administration Law of China that took effect on January 7, 2009, any drug-making company must be approved by authorities at provincial, autonomous regional or municipal levels, and must obtain a production...

  • Pharmacogenomics in Japan. Tamaoki, M.; Gushima, H.; Tsutani, K. // Pharmacogenomics Journal;2004, Vol. 4 Issue 5, p288 

    Explores the trend in pharmacogenomics in Japan. Establishment of infrastructure for pharmacogenomics; Ethical aspects of pharmacogenetics; Pharmaceutical laws related to pharmacogenomics; Application of the concept of pharmacogenomics in drug development.

  • PRICE COMPETITION AND THE EFFICACY OF PRESCRIPTION DRUGS: CONFLICTING OBJECTIVES? Jadlow, Joseph M. // Nebraska Journal of Economics & Business;Autumn72, Vol. 11 Issue 4, p121 

    Examines the effect of the 1962 drug amendments on price competition in drug markets in the U.S. Goals of the amendments; Impact of the amendments on drug research costs; Influence of the amendment on drug development; Description of the drug market in the country.

  • Tracking the Pulse of the Pharmaceutical Industry. Siew, Adeline // Pharmaceutical Technology Europe;Aug2014, Vol. 26 Issue 8, p6 

    An introduction is presented for the issue which discusses 25 years of pharmaceutical industry in Europe, views of several experts for advancements of technology in drug development and changes in European medicine regulations.

  • FDA: Pancreatic enzyme drygmakers must submit NDA. Gebhart, Fred // Drug Topics;5/17/2004, Vol. 148 Issue 10, p18 

    The U.S. Food and Drug Administration (FDA) dropped a long-awaited bombshell on makers of exocrine pancreatic insufficiency drug products. Manufacturers have four years, from 2004, to submit a New Drug Application for each of their products and receive marketing approval. Products not receiving...

  • The status of paediatric medicines initiatives around the world-what has happened and what has not? Hoppu, Kalle; Anabwani, Gabriel; Garcia-Bournissen, Facundo; Gazarian, Madlen; Kearns, Gregory; Nakamura, Hidefumi; Peterson, Robert; Sri Ranganathan, Shalini; Wildt, Saskia // European Journal of Clinical Pharmacology;Jan2012, Vol. 68 Issue 1, p1 

    Purpose: This review was conducted to examine the current status of paediatric medicines initiatives across the globe. Methods: The authors made a non-systematic descriptive review of current world situation. Results: Two regions, the United States (US) and the European Union (EU), and the World...

  • Novartis: market experience will help Tasigna.  // PharmaWatch: Monthly Review;Jan2007, Vol. 6 Issue 1, p6 

    The article reports that Novartis has completed its regulatory submission for its cancer drug Tasigna in the U.S. and European Union. Tasigna is intended for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia, that has become resistant or intolerant to prior therapy. It...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics