Module 6

04/10/2024

Development of the SmPC

Non Clinical

Clinical Development

MAA

HTA

Lifecycle Management

TPP - Specifies the goals of the development program

Target Product Profile

Company Core Data Sheet

CCDS - Synopsis of the Product Data

SmPC in EU and Product Information or PI in US

Summary of Product Characteristics

PIL Patient Information Leaflet or PL Product Leaflet

Product Leaflet

The Organisation for Professionals in Regulatory Affairs

HTA or HTAR= Health Technology Assessment

11

Target Product Profile (TPP)

● Early in development identify the claims you wish to make

● Multi-disciplinary team

– Medical, Clinical, Regulatory, Marketing, Nonclinical, CMC

● Sets the parameters for the development programme

– The population for the planned indication should be identical to that in the

pivotal studies

– Identifies what is minimally required vs desirable

The Organisation for Professionals in Regulatory Affairs

12

6