8
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Pharmaceutical laws and regulations in Iran: An overview

      review-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          The pharmaceutical legal framework is a very important infrastructure in achieving predefined goals in pharmaceutical sector: Accessibility, quality, and rational use of medicine. This study aims to review the current pharmaceutical sector-related legal provisions in Iran where the Food and Drug Organization (FDO) is in charge of regulating all issues related to the pharmaceutical sector. The main laws and regulations enacted by parliament and cabinet and even internal regulations enacted by the Ministry of Health or Iran FDO are reviewed. Different laws and regulations are categorized according to the main goals of Iran national drug policy.

          Related collections

          Most cited references13

          • Record: found
          • Abstract: not found
          • Article: not found

          The nature of innovation market failure and the design of public support for private innovation

            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Market Failure and the Poverty of New Drugs in Maternal Health

            A new survey finds that only 17 drugs are under active development for maternal health indications, which is less than 3% of the pipeline in cardiovascular health (660 drugs).
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Drugs for neglected diseases: a failure of the market and a public health failure?

              Infectious diseases cause the suffering of hundreds of millions of people, especially in tropical and subtropical areas. Effective, affordable and easy-to-use medicines to fight these diseases are nearly absent. Although science and technology are sufficiently advanced to provide the necessary medicines, very few new drugs are being developed. However, drug discovery is not the major bottleneck. Today's R&D-based pharmaceutical industry is reluctant to invest in the development of drugs to treat the major diseases of the poor, because return on investment cannot be guaranteed. With national and international politics supporting a free market-based world order, financial opportunities rather than global health needs guide the direction of new drug development. Can we accept that the dearth of effective drugs for diseases that mainly affect the poor is simply the sad but inevitable consequence of a global market economy? Or is it a massive public health failure, and a failure to direct economic development for the benefit of society? An urgent reorientation of priorities in drug development and health policy is needed. The pharmaceutical industry must contribute to this effort, but national and international policies need to direct the global economy to address the true health needs of society. This requires political will, a strong commitment to prioritize health considerations over economic interests, and the enforcement of regulations and other mechanisms to stimulate essential drug development. New and creative strategies involving both the public and the private sector are needed to ensure that affordable medicines for today's neglected diseases are developed. Priority action areas include advocating an essential medicines R&D agenda, capacity-building in and technology transfer to developing countries, elaborating an adapted legal and regulatory framework, prioritizing funding for essential drug development and securing availability, accessibility, distribution and rational use of these drugs.
                Bookmark

                Author and article information

                Journal
                J Res Pharm Pract
                J Res Pharm Pract
                JRPP
                Journal of Research in Pharmacy Practice
                Medknow Publications & Media Pvt Ltd (India )
                2319-9644
                2279-042X
                Jul-Sep 2016
                : 5
                : 3
                : 155-161
                Affiliations
                [1 ]Pharmaceutical Management and Economics Research Center, Tehran University of Medical Sciences, Tehran, Iran
                [2 ]Department of Pharmacoeconomics and Pharmaceutical Administration, Tehran University of Medical Sciences, Tehran, Iran
                [3 ]Department of Pharmaceutics, Tehran University of Medical Sciences, Tehran, Iran
                [4 ]Department of Economics, Shahid Beheshti University, Tehran, Iran
                Author notes
                Corresponding author: Prof. Abbas Kebriaeezadeh, E-mail: kebriaee@ 123456tums.ac.ir
                Article
                JRPP-5-155
                10.4103/2279-042X.185709
                4966232
                27512704
                5c9cda2c-2f24-4f89-8b52-b59a96d37037
                Copyright: © 2016 Journal of Research in Pharmacy Practice

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

                History
                : February 2016
                : May 2016
                Categories
                Review Article

                accessibility,availability,counterfeit medicines,pharmaceutical trade-related aspects,rational use of medicine

                Comments

                Comment on this article