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Multi-country regulatory filing strategy

Multi-country regulatory filing strategy with CTDsThe current issue of RAPS Focus contains an interesting article on how drug companies can use a strategic, multinational approach (PDF link) to greatly increase the chance of marketplace success for both new and existing pharmaceutical products.

At the heart of such a strategy is the Common Technical Document (CTD).
Thanks to ICH M4 guidelines (PDF link), the CTD provides a standardized structure for regulatory submissions across all ICH member countries and, following adoption of a similar ACTD format, across ASEAN countries as well.

Although the CTD is fairly standardized around the globe, there exist significant differences in regulatory filings in the EU, U.S., and other countries and trading blocks. The authors make a good argument for the importance of local knowledge. Their experience has shown that "knowledge of regulatory differences and other country-specific requirements is crucial to the success of any multi-country submissions strategy."

With ever-increasing time-to-market pressures, pharmaceutical companies are increasing their efforts to understand these regional differences and build robust CTDs.


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