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Drug Product Registration in US, EUROPE, JAPAN and CANADA for New Drug and GenericsBy Thomas S., Dixit M., Charyulu R.N., Bengre P., Rao M.S., Shetty A
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 →