Advances in Pharmaceutical Market Integration in Mercosur and Other Latin American Countries
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ADVANCES IN PHARMACEUTICAL MARKET INTEGRATION IN MERCOSUR AND OTHER LATIN AMERICAN COUNTRIES MARCELOJ. VERNENGO,PHD Universidad de Belgrano, Buenos Aires, Argentina
KEES DE
JONCHEERE, MSC, MBA
Regional Office for Europe, World Health Organization, Copenhagen, Denmark
ENRIQUEFEFER,PHD Program Coordinator, Essential Drugs and Technology, Pan American Health Organization, World Health Organization, Washington, Disfrict of Columbia
This paper reviews the developments in the pharmaceutical sector in the MERCOSUR countries which have resultedfrom the renewed efforts of economic integration in Latin America. MERCOSUR refers to the “Mercado Comun del Sur,” the common market that has been under development since 1991 by Argentina, Brazil, Paraguay, and Uruguay. In MERCOSUR the underlying principles for harmonization of pharmaceutical legislation and regulations are that there is no centralized approval system (apharmaceutical product needs to be registered at the national level before it can be marketed in a country) and that requirements and procedures for registration should be the same in all countries. By the end of 1995, the MERCOSUR countries had adopted common good manufacturing practice (GMP)guidelines for production of large parenteral solutions and an inspection guide, a common guide for inspection of production facilities of pharmaceutical products, common requirements for production facilities for pharmaceutical ingredients and raw materials, an inspection guide for raw materials’ production facilities, common guidelines on GMP and quality control of blood products, and a strategy for the transition period stretching until 1999. It is concluded that the opening of markets has already brought not only adoption of GMP standards but general movement toward clearly defined technical requirements for the registration ofproducts. This will strengthen national regulatory systems and consumer protection. The harmonization process will strive to reach international standards, with the World Health Organization (WHO) and the International Conference on Hannonization (ICH) as references. Multinational companies will review their production policies and plant locations. National companies will review their portfolio of products looking for specific “niches” in the pharmaceutical market; and they will need to be prepared for increased competition from foreign companies. Further concentration of the domestic industry is likely to OCCUT. Key Words: Economic integration; Regulatory harmonization; Latin America; MERCOSUR; Pharmaceutical markets
Reprint address: Enrique Fefer, PhD,Program Coordinator, Essential Drugs and Technology, Pan American Health N. W..from Washington, 20037. Organization, 525 23rd Street, Downloaded dij.sagepub.comDC at Univ Politecnica De Valencia on May 29, 2015
M.J. Vernengo, K. de Joncheere, and E. Fefer
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INTRODUCTION IN RECENT YEARS, political and economic developments have resulted in renewed efforts of economic integratio
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