Provision of information on regulatory authorities’ websites
Several organizations have raised concerns about the excessive secrecy maintained by regulatory authorities around the world, in particular in the European Union, France, UK, Canada and Australia. However, limited research has assessed the provision of information by regulatory authorities. This study aimed to assess the type and availability of information provided on the regulatory authorities’ websites. Methods:
Regulatory authorities’ websites in six countries (USA, Canada, UK, France, Australia and New Zealand) and at the European level (European Medicines Evaluation Agency) were surveyed by two reviewers between October 2005 and March 2006. The survey instrument included 16 criteria organized in 3 domains: information on marketed drugs, information on assessment of drugs and information on drug safety. Results:
There was a great variability in the level of information provided. Several medicine agencies did not provide basic information on marketed drugs, such as the summary of products’ characteristics. Information on registration dossiers was scant on most websites except that of the US Food and Drug Administration. The European Medicines Evaluation Agency, the French agency and the Canadian agency released public assessment reports that contained only summarized information of registration data. Only one country, Canada, provided full access to pharmacovigilance data. The periodic safety update reports that companies have to provide regularly to regulatory authorities were not available in any country. Conclusion:
Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.
Document Type: Research Article
Affiliations: 1: School of Health Policy and Management, York University, Canada 2: LECOM School of Pharmacy, USA 3: Pharmacology, Pharmacokinetics and Clinical Pharmacy Laboratory, University of Lille 2, France 4: Health Action International, The Netherlands 5: Regulatory policies laboratory, Mario Negri Institute for Pharmacological Research 6: Mario Negri Institute for Pharmacological Research, Italy 7: School of Medicine, University of Otago, New Zealand 8: Australian Medicines Handbook, Australia
Publication date: 01 July 2008