Emerging Markets and Emerging Agencies: A Comparative Study of How Key Regulatory Agencies in Asia,Latin America,the Middle East,and Africa are Developing Regulatory Processes and Review Models for New Medicinal Products

Abstract

An ongoing study has been set up by the CMR International Institute for Regulatory Science to record and analyze the regulatory procedures for the authorization of new medicines in 13 key countries, outside the ICH regions, where the pharmaceutical market is expanding or the regulatory agency plays an important role in regional development. These countries are Argentina, Brazil, Mexico, Egypt, Saudi Arabia, South Africa, China, India, Indonesia, Malaysia, Singapore, South Korea, and Chinese Taipei. In the study, data were collected from senior personnel in the national agencies and from multinational pharmaceutical companies on the review and assessment processes for new active substances (NASs) and major line extensions (MLEs). The quality measures being applied by the agencies to monitor those procedures were also recorded. The design of the study collected information for a status report at one time point, as summarized here, but also provides the basis for recording and benchmarking the progress and changes made by the agencies over time. A cross-comparison of information from the authorities indicated that regulatory aspirations, barriers, and priorities are essentially similar across agencies. The review steps are also similar although there are major differences in the assessment process. Most agencies are using risk stratification methods for their review of new medicines, based on the level of regulatory scrutiny the product has already undergone by agencies elsewhere. There is an awareness of the importance of building quality into agencies' regulatory processes and practices and this is a changing and evolving area.