Authors: Bindu Narang and Dr. Rajendra Wable, Sciformix Corporation
For any biopharmaceutical, submitting a new drug application (NDA) is the ultimate goal and a mandatory step for commercialisation. As biopharmaceutical companies plan to put their product out in multiple markets, they have to consider a global regulatory strategy for registration in the developed countries as well as in several emerging
market countries. However, differing registration requirements across markets are a burden. Knowledge of the drug registration processes and submission content is key for effective planning and execution of global regulatory strategy. A step-by-step approach is essential to
make any global submission successful.
This article will discuss regulatory requirements for product registration in different geographic regions, key similarities and differences in the regulatory requirements and the opportunities and challenges in repurposing or reformatting an existing market dossier for registration in new markets worldwide.