SUMMARY

Pre-Sub Activities refer to the regulatory activities conducted by an National Regulatory Agency (NRA) prior to the submission of a marketing authorization application for a medicinal product.
These activities aim to ensure that the submitted data and documentation meet the regulatory requirements and address any potential gaps or deficiencies before the formal submission of the application, and can include scientific advice, protocol assistance, and qualification of novel methodologies to ensure the quality, safety, and efficacy of medicines before they are approved for market release.
During Pre-Sub activities, the NRA engages in discussions with the applicant to provide guidance and feedback on various aspects of the submission. This includes discussions on study design, data collection, analysis plans, and regulatory requirements. The purpose is to help the applicant understand the NRA’s expectations and requirements, and to ensure that the submission is complete, accurate, and of high quality. This includes FDA CDER’s Pre-Investigational New Drug Application (IND) Consultation Program, also EMA procedural advice, drug designation, PIP-, SA-, ITF-, SME- meetings, etc.