1、ICON 2023Global agency meetings:A collaborative approach to drug developmentSponsors 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 app

2、roval 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.Here,we explain what types of agency meetings can be sought

3、 in the EU,the US,Japan,China,and Canada and provide details to guide sponsors in requesting and preparing for successful agency interactions.Regulatory authorities share sponsors goal of delivering safe and effective drugs to patients and of doing so as efficiently as possible.They,therefore,offer

4、a number of different opportunities for sponsors to seek their advice and direction at various stages of development.These range from early consultation services to scientific advice meetings on protocol designs to discussions of regulatory issues that arise in the course of development.ICON EU scie

5、ntific adviceThe European Medicines Agency(EMA)and the European Union(EU)national competent authorities(NCA)offer several opportunities for sponsors to engage and discuss scientific,technical,and regulatory topics with the agency(ies)at any stage of the development.Sponsors are encouraged to seek sc

6、ientific advice via the EMA,scientific advice working party(SAWP),or via NCA national or simultaneous national scientific advice(SNSA).Of note,national agency experts serve as members of the EMAs scientific committees,working parties,or in assessment teams.A list of NCAs can be found here.EMA scient