بررسی مقایسه ای الزامات ثبت دارو در کشورهای CIS در مقایسه با الزامات ثبت دارو در ایران

بررسی مقایسه ای الزامات ثبت دارو در کشورهای CIS و مقایسه با الزامات ثبت دارو در ایران در این پزوهش تحقیقاتی کلیه موارد مربوط به نظام داویی کشورهای حوزه CIS با الزامات کشور خودمان سازمان غذا و دارو مقایسه گردید 

Introduction: Drug is one of the most important commodities in today's human trade and its impact on human health and today the pharmaceutical industry itself is one of the key and very important strategic industries in the world. These industries are different in the world markets than other high-tech industries, because they are the function of innovative research, investment, and government regulations. And the cost of investment to creating innovate in these industries is more than the other industries because its nature. [1] The world's pharmaceutical market value exceeds 1 billion$ in a year. The entry into this important market and strategy always has been a concern for economists and the governments. The production massive of the products of this industry is based on high-tech manufacturing, For this reason, this industry is categorized in the Upper Industrial class and Knowledgebase. For this reason, having such an industry is one of the important criteria for developing countries. [2] On the other hand, the quality, safety and efficacy of pharmaceutical products are always one of the important issues that are among consumers, manufacturers, regulatory and regulatory systems, national and international standardization systems, and drug policy makers. [3] Because the lack of quality, safety and efficacy in pharmaceutical process will danger the lives of people in society, the wasting of financial resources, and people's uncertainty to ministry of health and professionals and regulatory systems. [95] If medicinal products have good quality, affordable, with reasonable consumption and accessible prices and are used, finally, ultimate goal of the health system is promotes the health of the community will be realized. In each community, the government for promote and improve the health of the community, is ultimate goal of MOH, formulated and develops health policies by MOH. national drug policies Part of the health policy system. One of the key components of the national drug policy in the countries is the necessity for providing laws and regulations for all the section of the pharmaceutical system and having appropriate structures for the pharmaceutical system in the field of manufacturing, registration, distribution, prescription, traceability and pharmaceutical information to ensure quality, safety And the efficacy of pharmaceutical products, and the need for the continuous implementation and improvement of the pharmaceutical system is to have a strong and clear Drug Regulatory Authority in each country [4].