Affiliations: World Health Organization Collaborating Centre for Pharmacoepidemiology & Pharmaceutical Policy Analysis, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands | Quality Assurance and Safety for Medicines, Essential Medicines and Pharmaceutical Policies Department, World Health Organization, Geneva, Switzerland | Medicine Information and Evidence for Policy, Essential Medicines and Pharmaceutical Policies Department, World Health Organization, Geneva, Switzerland
Note: [] Address for correspondence: Dr Samvel Azatyan, Manager, Medicines Regulatory Support Programme, Quality Assurance and Safety: Medicines, Essential Medicines and Pharmaceutical Policies Department, World Health Organization, 20, Avenue Appia, CH-1211, Geneva 27, Switzerland. Tel.: +41 22 791 1506; Fax: +41 22 791 4167; E-mail: [email protected]
Abstract: Background: Medicines Regulatory Authorities (MRAs), among other core regulatory functions, play a vital role in stimulating the rational use of medicines by providing regulatory information of good quality to all stakeholders. Little research has attempted to report on existence and maintenance of MRA websites at global level, as well as the types of information made publicly available. Objectives: To identify functioning MRA websites on a global level, to update a study carried out in 2001 on the development of the quality and types of information of 51 websites, and to identify model components within existing websites. Methods: The Internet was searched and WHO Medicines Regional Advisers and WHO medicines country advisers (National Professional Officers) were contacted in order to identify MRA websites. The 51 websites assessed in 2001 were assessed again, using the same criteria for the quality and types of information as in 2001. Results: The number of MRA websites identified has risen from 53 to 116. Most criteria, such as frequency of updates, pharmacovigilance information and regulatory guidance for applicants for medicines marketing authorization (registration) have improved substantially. However, navigability of websites has weakened. Conclusion: Quantitative growth of the number of MRA websites is impressive. The quality of information provided on the 51 assessed websites has improved. Exemplary website components are proposed to help MRAs to improve transparency by developing and maintaining high-quality websites.
