Global agency meetings:

Regulatory authorities share sponsors’ goal of delivering safe and effective drugs to patients – and of doing so as efficiently as possible. They offer a number of different opportunities for sponsors to seek their advice and direction at various stages of development.

Sponsors who take advantage of this collaborative approach to drug development can align their development plans with agency expectations and are in the best position to ensure that their licensing applications meet with approval following a smooth and timely assessment. Ultimately, of course, this benefits patients by ushering medicinal products to market faster. Each global region, however, has its own specific consultation offerings, procedural steps, and timelines.

In this briefing document we explain what types of agency meetings can be sought in the EU, the US, Japan, China, and Canada, and provide details to guide sponsors in requesting and preparing for successful agency interactions.