Global and Regional Drug Regulatory Harmonization Initiatives
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Global and Regional Drug Regulatory Harmonization Initiatives
'"' Global M'Regulatory L'kkis' pbD' Affairs, RAC Merck Koy Words Pharmaceutical regulatory harmonization; European harmonization: Global Cooperation Group; ASFAN; APEC; GCC; PAHO: PANDRH; SADC; WHO Corrrspondrnco Addrrss Maha M. Lukkis. PhD, RAC, Merck. Global Regulatory Affairs, 2000 Galloping Hill Road, Mail Stop: K6-1429, Kenitworth, NJ 07033 (email: [email protected]).
The diversity of pharmaceutical regulatory requirements makes marketing new drugs a very complex and costly process that delays public access to innovative and essential drugs. In recent years, the pharmaceutical industry has become increasingly multinational, taking advantage of the growing opportunities in the mpidly expanding new markets in Asia, Latin America, the Middle East, and Afica. This globalization trend created the need for a new strategic approach to pharmaceutical regulations, leading to more international cooperation and hmmonization. Globalization of pharmaceutical regulatory standards has become a necessity and a goal for many groups of neighboring countries in several regions of the
IN T R O D U C T l O N Marketing of pharmaceutical products is highly regulated because it involves several ethical and human health and safety implications. Pharmaceuticals are regulated by governments via specialized drug regulatory authorities that have the responsibility to ensure the quality, safety, and efficacy of medicines before approving their marketing by granting marketing authorizations to qualified medicines, which allows their availability to the public. One of the main obstacles to international approval of pharmaceutical products is that different models for regulation of medicines exist in countries across the world. The diversity of the regulatory requirements in different countries makes pharmaceutical drugs' applications and marketing a very complex and costly process that often delays access of the public to essential and often life-saving drugs. In addition, lack of respect for the Trade-Related Intellectual Property Rights (TRIPS) agreement, strong price controls, and generic competition in most emerging and developing countries remain a challenge for pharmaceutical compa-
wdd to reduce unnecessary and duplicative requirements, mtionalize time and costs, and create a transparent regulatory process that improves access to medicines. Regional hannonization is chamcterized by a number of initiativesdriven mainly by common economical and social needs and supported by global organizations such as WHO and ICH. This artide provides an introduction to the major global and regional drug regulatory hannonization initiatives. These initiatives are at dinerent stages of development and maturity, those including the more established counties being at more advanced stages than the lessresourced ones.
nies and hinder the marketing of innovative drugs in these markets. Historically, drug regulations in different countries evolved independently of each other, affecte
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