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A Biotech Manager's Handbook by M Hopkins, M O'Neill

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10

Successful registration of new therapies in the EU and USA

Gerard McGettigan and Michael O’Neill

Abstract.

This chapter summarises the main regulatory frameworks operating in the major pharmaceutical markets as operated by the Regulatory Authorities in the EU, the USA and with a brief reference to Japan. There is a high degree of convergence in the requirements for a marketing authorisation under the International Convention on Harmonisation but there are still important differences in the content and procedures that need to be taken into account. A huge amount of detailed information is now available on-line from the regulatory agencies. Considerable time and care is still required to navigate through the different regulatory processes. ...

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