Drug approval of a new drug is the goal of the long process of drug development. Once the data of preclinical and clinical trial have been collected, a New Drug Application must be submitted to the regulatory authority of the country for approval. Although the requirements for this submission have similarities around the world, until now, the applications have been different In different countries. Regulatory authorities working under the umbrella of the International Conference on Harmonisation. Main objective of the approval procedure is to provide safety,efficacy and qualityof drugs to the society and human beings.so this article contains different new drug approval procedures for countries like India, America, Canada, Europe and Japan.
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