Guidance for assessment and evaluation of changes to drug delivery systems

This document provides guidance for assessment and evaluation of planned changes to drug delivery systems that are integral with, packaged with, or cross-labelled for use with a specified medicinal product. This document is applicable to the drug delivery system's lifecycle from registration clinical studies to end-of-life. This document is applicable to the assessment of changes within the following drug delivery systems:

— needle-based injection systems for medical use;

— aerosol drug delivery devices;

— needle-free injectors for medical use.

NOTE These are covered by the ISO 11608 series, ISO 20072 and ISO 21649, respectively.

This document might also be useful for assessing and evaluate changes to other drug delivery devices or systems.

Examples of changes that are within the scope of this document include but are not limited to the following:

a) the same route of administration (e.g. change resulting in including a marketed prefilled syringe to an autoinjector);

b) changes to the drug delivery system design (e.g. change in configuration or layout of electrical and mechanical components);

c) changes to the medicinal product that affect the drug delivery system; includ