ICH Q12 Guideline: Prospects for Implementation in the EAEU Legislation

INTRODUCTION. In 2019, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted the new ICH Q12 guideline on pharmaceutical product lifecycle management. It covers all change categories listed in Module 3 (Quality) of drug Registration dossiers and Master files for the pharmaceutical substance and other products. Its application is expected to help optimise change management, reduce approval and implementation time, and mitigate the risks for patients. As of August 1, 2025, the document is considered implemented in three ICH member countries: USA, Japan, and China.

AIM. This study aimed to discuss implementation prospects of ICH Q12 guideline in the EAEU legislation.

DISCUSSION. Eight tools and mechanisms recommended for post-approval change management regarding quality were assessed for their novelty in relation to existing commonly accepted principles and approaches to drug quality regulation. The analysis included experience of ICH member countries that have implemented or are implementing the guidance; pilot projects conducted; and changes related to legislation and internal procedures. So far, only the USA managed a full-fledged implementation of the document. The authors have considered the experience of pharmaceutical companies that made changes according to ICH Q12. Analysed current EAEU legislation regarding regulation of pharmaceutical products has shown that, in order to effectively apply the regulatory tools and mechanisms of the ICH Q12 Guideline, a number of fundamental amendments to Eurasian Economic Council documents (Decisions No. 77, 78, 84, and 91) is warranted, as well as an EAEU-adapted version of the Q12 Guideline, the restructured internal procedures of regulatory authorities and their subordinate expert institutions, and a pilot project to test the new administrative procedures.

CONCLUSIONS. The Q12 guidance will help transform quality change management for approved pharmaceuticals, currently a bureaucratic hurdle, into a mechanism for innovation, scientific and technological progress, and continuous product improvement. Implementing the guidance will require both legislative modifications and improved internal procedures of regulatory bodies and pharmaceutical companies. Among the proposed Q12 mechanisms, change management protocols have been the most successful experience. The Eurasian Economic Union (EAEU) provides all the basic prerequisites for Q12 implementation; however, a number of fundamental and technical issues remains unresolved, including national drug regulation systems of the EAEU member states, changes to existing documents, and the development of new ones.

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