Master Plan: Dossiers For Pharma

November, 2015
Author: Dr. Rajendra Wable, Sciformix Corporation

The pharmaceutical industry is highly regulated, with rules enforced by the health agencies to protect the consumer. The number of regulatory requirements has grown exponentially as biopharmaceutical companies enter new and disparate markets, but efforts in global regulatory harmonisation have stalled. To support the global growth imperative, regulatory functions must meet the local needs of a greater number of countries, while supporting an expanding list of products and aggressive project timelines. Differing registration requirements across markets are a burden, however, it is possible for them to use the differences to a certain extent. This can be achieved, for example, by registering products in countries like the US or across the EU that has streamlined regulatory requirements and use these initial registrations to support registration in other countries.

Preparing one core dossier first and adapting it to the regional specificities in a second step (the ‘parallel preparation’ approach) can allow optimising resources and may lead to a faster global registration. Similarly, a sequential approach (preparation of the NDA first and then conversion to an MAA, or vice versa) can allow the applicant to obtain feedback from the first agency and make adjustments to the second dossier prior to its submission, if relevant.

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