This guideline provides a framework to facilitate the management of post-approval CMC changes in a
more predictable and efficient manner.
The examples provided in Annex IA through IF are mock examples provided for illustrative purposes. They only suggest how the tools described in chapters 3, 4, and 5 could be applied, and should not be
used as a template or the sole basis for a regulatory submission.
The ICH Q12 guideline provides regulatory tools and enablers with associated guiding principles,
which are intended to harmonise globally the management of quality related post-approval changes.
Some of its principles have been inspired by the current EU legal framework on variations.
This Reflection Paper is focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission guide to GMP refers, in several places, to MAHs and their responsibilities in relation to GMP.
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR) (hereafter
called the Medical Devices Regulations) have been adopted and entered into force on 25 May 2017.
The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics.
This document provides practical guidance for GMP inspectors when seeking to evaluate the effectiveness of a company’s pharmaceutical quality system (PQS) in relation to risk-based change management.
Area of operations / items
Questions/Show me
References (where applicable)
This Question and Answer (Q&A) document provides practical considerations concerning the
implementation of the medical devices and the in vitro diagnostic medical devices regulations
Compliance with good clinical practice (“GCP”) is mandatory for clinical trials that are conducted in the EU. These Guidelines develop the GCP requirements that are specific to clinical trials conducted with ATMPs. These Guidelines are to be read in conjunction with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on good clinical practice,3 which are also applicable to ATMPs.
