Technical Guidance Papers

Filed under:

Regulatory affairs

Introduction

Here you can find an archive of ECPA Technical Guidance Papers (TGPs). The first TGP has been developed in 2011 and the aim is to have common standards that can be used by industry to provide standardized submissions to meet numerous requirements set out within the framework of Regulation 1107/2009.

ECPA Technical Guidance Paper, No: 2011/1

Technical guidance for applicants in preparing a concise efficacysummary as part of a draft Registration Report (dRR)

This Technical Guidance Paper (available for download below) has been developed to provide guidance for applicants in preparing a concise efficacy summary within the framework of the draft Registration Report (dRR), part of the Core Assessment relevant for EU product evaluations.

If you have any comments and/or suggestions for the further development of the Technical Guidance Paper, please send them to aurelie.dhaussy@ecpa.eu

Attachments:

TGP for applicants in preparing a concise efficacy summary as part of a dRR (130 KB doc)