Argentina Regulatory Issues
Argentina Regulatory Issues
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With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
Publisher: Datamonitor Healthcare
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Unpredictable IP environment poses threat for multinationals
With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America. However, an unpredictable regulatory environment presents a significant barrier for multinational pharmaceutical companies’ expansion in the country.
Summary
- Copy drugs or similares are allowed to thrive in Argentina as the regulatory agency ANMAT does not require bioequivalence studies to approve drugs.
- Argentina was a hugely popular South American destination for clinical trials over 2005–11, second only to Brazil.
- There are no provisions for data exclusivity in Argentina, and lack of linkage between regulatory reviews and patent status leads to increased risks of patent infringement
Table of Contents
4 EXECUTIVE SUMMARY
5 REGULATORY OVERVIEW
5 ANMAT is the key drug regulatory body
9 CLINICAL TRIALS REGULATION
9 Healthcare and regulatory infrastructure foster a positive environment for clinical trial
outsourcing
14 INTELLECTUAL PROPERTY RIGHTS
14 Argentina’s IP system’s shortcomings place it on the US Trade Representative Priority Watch
List
18 BIBLIOGRAPHY
List of Figures
10 Figure 1: Approval and set up process in Argentina
11 Figure 2: Number of Phase II and Phase III trials in key Latin American markets, 2005–11
12 Figure 3: Clinical trial sponsors (Phase II and III trials) in Argentina, 2005–11
List of Tables
9 Table 1: Clinical trial timelines in Argentina
Table 1: Clinical trial timelines in Argentina
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