EMA Explains Unique Implementation of ICH Q12 Guideline

Regulatory NewsRegulatory News | 04 March 2020 |  By 

While explaining that the EU legal framework always takes precedence over guidelines, the European Medicines Agency (EMA) on Wednesday outlined considerations for implementing the International Council of Harmonisation’s (ICH) Q12 guideline on technical and regulatory considerations for pharmaceutical product lifecycle management.

The guideline, which was adopted by EMA’s Committee for Medicinal Products for Human Use in January, has some conceptual differences with the EU legal framework, which EMA says, “have an impact on how the full operational and regulatory flexibility as laid down in the ICH Q12 guideline can be implemented in the EU.”

For instance, EMA says that industry can adopt some of the tools and concepts foreseen in the ICH Q12 guideline by merely following the current EU variations framework.

“However, additional scientific risk-based approaches to defining Established Conditions and associated reporting categories, as described in Chapter 3.2.3, and the Product Lifecycle Management (PLCM) Document, as described in Chapter 5, are not considered compatible with the existing EU legal framework on variations,” EMA adds.

In addition, the regulator notes that the definition of “Established Conditions” and their reporting categories must follow the requirements laid down in the current EU variations regulation and associated EU guidelines.

“With respect to the Product Lifecycle Management (PLCM) document, in case such a document is submitted, it cannot be currently recognised in the EU due to the fact that it is not referred to in the EU legal framework. With regard to Chapter 6 ‘Pharmaceutical quality system (PQS) and change management’ and Chapter 7 ‘Relationship between regulatory assessment and inspection’, while the expectations on industry and regulators are broadly in line with current practice in EU, some additional clarifications regarding demonstration and evaluation of PQS effectiveness and communication between regulators will require further consideration during implementation of the guideline,” EMA adds.

Other tools and concepts in the Q12 guideline that are not in the EU legal framework will be considered when this framework is reviewed, EMA adds.

Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy