Regulatory Review Expediting
In the global effort to speed therapies to market, regulatory agencies are engaging with sponsors and with each other more than ever before. This collaborative spirit benefits not only the agencies, but also patients and sponsors.
China’s focus for joining the ICH centered on resetting its regulatory processes for the approval of innovative therapies. Whereas it used to take roughly two years to obtain approval to conduct a clinical trial in China, it now takes 60 working days to gain approval from the National Medical Products Administration (NMPA).
Pursuing expedited pathways in multiple geographic regions may give sponsor companies several advantages. Tapping into global populations not only serves to increase patient recruitment, but also may help ensure more accurate clinical knowledge of how a product works within diverse patient populations.
In the rapidly changing global regulatory landscape, strategic planning is essential. A sound starting point is to consider a regulatory strategy plan coupled with a clinical development plan, which will assist in awareness of the necessary timing and requirements for expedited pathways. Plans should be flexible and adaptable according to data, intelligence, and results.
A good regulatory partner will have the expertise to know when and where to employ various expedited pathways and to help sponsors decide an optimal strategy. They will also have experience effectively managing relationships with regulatory agencies—from presenting applications in a timely and effective manner, to preemptively answering regulators’ questions and addressing their concerns. Well-thought-out, high-quality submission documents are crucial whether a sponsor is requesting a meeting or applying for a designation.