Prescription Drug Approval Process: Asia

In most economically thriving parts of Asia, current regulatory procedures governing prescription drugs are basically similar to those found in other major markets around the world. Even so, when negotiating and adopting global standards for the availability and accessibility of pharmaceuticals, Asian states have a range of different interpretations and focuses.

The process of approving new drugs in Asia begins with the sponsors applying either for investigational new drug (IND) or new drug application (NDA) status for their products and submitting to the regulatory authorities all [Page 1142]the necessary information regarding quality, safety, and efficacy. On the basis of the submissions, the regulatory authorities either approve or reject the applications. Unlike benchmark agencies in the United States and Europe, many regulatory agencies in Asia ask external ...