Taking On the World: One Size Does Not Fit AllMaximising international opportunities can create a substantial administrative headache, which is why standardisation offers such a positive way forward. But, says Adam Sherlock, this could - and should - mean different things to different companies.

摘要

Simultaneous multimarket entry is a growing reality for the pharmaceutical industry as regulatory agencies worldwide move to further standardise the format and structure for submissions. Growing acceptance of the electronic common technical document (eCTD) standard for submissions is paving the way for standardisation and greater efficiencies, certainly, but there is still some way to go.Beyond the US market, where efficient, modern electronic submission standards have been accepted and bedded down, the regulatory environment remains complex and inconsistent.Outside the US, submission requirements still vary considerably from one country to the next, especially across Europe. This renders the situation challenging, particularly in markets where internal resources begin to thin out - for example, where the responsibility for managing submissions falls to small affiliates that may be overstretched already.