Available on CD-ROM, this interactive tool addresses the Indian regulatory systems for product approval in the areas of drugs, vaccines, biopharmaceuticals, medical devices and diagnostics, and biofortified foods. It compares the Indian and US Food and Drugs approval processes; lists key institutions and individuals in India involved in regulatory approvals; lists organizations, committees, and groups that are part of the regulatory system; and provides a database of referenced extracts of key legislations, forms, and templates. This interactive tool allows users to build and analyze various scenarios of product approval applications. Easy-to-navigate and hyperlinked flowcharts provide indicative timelines for approvals, so users can map the various stages in the approval process.
Corporate author(s): PATH
Publication date: December 2007
Indian Regulatory Systems for Product Approval
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Contact: PATH Publications
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