Emerging Markets and Emerging Agencies: A Comparative Study of How Key Regulatory Agencies in Asia, Latin America, the M
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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 Neil McAdane, BSc, MSc, PhD Director, CMR International Institute for Regulatory Science, United Kingdom Margaret Cone, BPharm, MRPhormS Director, Regulatory Publications, CMR International Institute for Regulatory Science, United Kingdom Jennifer Collins,' MA, BSc, MSc CMR Institute for Regulatory Science, United Kingdom Stuart Walker, BSc, PhD, MFPM, FRSC, FlBiol, FinrtD, FRCPath Vice President and Founder, CMR International Institute for Regulatory Science, United Kingdom
Key Wards Regulatory review: Emerging markets: New medicines: Quality measures:Asia, Latin America. Middle East, and Africa Correspondence Address Dr. Neil Mduslane. CMR International Institute for Regulatory Science, The Johnson Building, 77 Hatton Gardens, London ECl N 8JS.United Kingdom (email: [email protected]).
'Ms. Collins was formerly with CMR International Institute for Regulatory Science and is now with GlaxoSmithKline. Weybridge. Surrey, UK.
An ongoing study has been set up by the CMR InternationalInstitutefor Regulatory Science to record and analyze the regulatory procedures for the authorizationof new medicines in I3 key countries, outside the ICH regions, where the pharmaceutical ma& is expanding or the regulatory agency plays an important role in regional development. These countries are Argentina, Brazil, Mexico, Egypt, Saudi Arabia, South Afnca, 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 PASS) and major line extensions (MLEs). The quality measures being applied by the agencies to monitor those proce-
INTRODUCTION When the regulatory review and approval of new medicines is studied at a global level, it is apparent that the division between the International Conference on Harmonization (ICH) regions and the rest of the world is changing and is no longer so well defined. The CMR International Institute for Regulatory Science (hereafter the Institute) has been studying the regulation of medicines in some of the so-called emerging markets in order to benchmark and analyze these changes, particularly in relation to the availability of new medicines to patients in the countries studied. For the purposes of this study, the term emerging markets was used to encompass not only those countries with an expanding phar-
dures 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 ess
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