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Drug Product Registration in US, EUROPE, JAPAN and CANADA for New Drug and Generics

Thomas S., Dixit M., Charyulu R.N., Bengre P., Rao M.S., Shetty A


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 approval of new drug and generic drug. Europe follows different kinds of procedures for the approval of drugs. There is also difference in the duration required for the approval of drug to reach the market. Even though these countries follow harmonized procedures, it is impractical to get global marketing approval at same time and launch in all the regions at one go due to different type of applications and the different procedures. This article discusses the basic requirements for a drug product to reach the market.


Keywords: NDA, ANDA, PMDA, TPD

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