Research & Reviews: A Journal of Drug Formulation, Development and Production
Volume 1, Issue 3 (2014)
Published
Table of contents
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Drug Product Registration in US, EUROPE, JAPAN and CANADA for New Drug and Generics
Abstract: Getting a marketing approval includes various junctures such as getting drug substances from approved vendors, finished product development, clinical studies, plant inspection, dossier writing and finally submission to authorities. US, Europe, Japan and Canada are the countries which are regulated for the approval of pharmaceutical products. These countries follow the ICH guidelines for the registration of drug of drug product. But each country has different type of application for the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 1–7 Read article
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Regulatory Requirement for Pharmaceutical Marketing in USA, EU and GCC: A Comparison
Abstract: The Gulf Cooperation Council (GCC) pharmaceutical are known to be a semi-regulated market when compared with European Union (EU) and Unites States of America (USA) drug regulatory market. Product registration in GCC was challenging task in comparison to EU and USA due to lack of proper harmonised guidelines and diversity in registration procedure. The six GCC member states namely Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates have …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 16–21 Read article
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Pharmaceutical Drug Product Registration and Requirements in Latin American Countries
Abstract: The regulatory process to obtain marketing authorization’s (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. This article offers a practical overview of product registration processes in LATAM. Although the International Conference on Harmonization (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. Additionally, a significant amount of mandatory …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 22–29 Read article
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Marketing Authorization Procedure and Their Requirements for Pharmaceutical Products in European Union
Abstract: Developing a new drug requires a great amount of research works in chemistry, manufacturing, controls, preclinical science and clinical trials. European Union (EU) is a hub of political and economic union of 28 member states (MS) and extensive amount of effort was spent by the EU Commission, the EU parliament, the European Medicines Agency (EMEA) and the national authorities in updating the EU regulatory environment for pharmaceuticals and granting marketing …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 8–15 Read article