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Purpose <p>The European Medicines Agency (EMA) guideline <i>Declaration of Storage Conditions in the Product Information of Medicinal Products</i> (CPMP/QWP/609/96/Rev.2) was last revised in 2007. Since then, advances in stability science, increased climatic variability, and evolving regulatory expectations have highlighted limitations in the framework, particularly the use of vague descriptors such as “room temperature” or “no special storage conditions.” This work reassesses the scientific and regulatory basis for storage statements, integrating current understanding of mean kinetic temperature (MKT), climate-related risks, and developments in ICH and WHO guidance, and proposes a harmonized revision (Rev.3).</p> Methods <p>A structured analysis of regulatory and scientific principles was conducted, incorporating MKT, climate-related risks, and developments in ICH and WHO guidance. These elements informed a revised framework and model storage statements, including a decision table linking stability outcomes to label statements.</p> Results <p>The proposed update introduces explicit temperature-based statements, strengthens the linkage between stability data and label wording, clarifies requirements for moisture- and light-sensitive products, expands guidance for sterile and reconstituted preparations, and provides contingency instructions for temperature excursions. A decision table mapping stability outcomes to label statements is included to support regulatory implementation.</p> Conclusion <p>This revision provides an updated synthesis of EMA, ICH, and WHO requirements, translating regulatory principles into clear storage statements and contingency guidance. It offers a more precise framework reducing ambiguity, supports justification of storage conditions through stability data and MKT-informed risk assessment, aiming to improve understanding among patients and healthcare professionals, strengthening real-world product quality and contributing to future EMA guideline development.</p> Highlights <p><UnorderedList Mark="Bullet"> <ItemContent> <p> Identifies scientific and regulatory limitations in current “no special storage conditions” terminology;</p> </ItemContent> <ItemContent> <p> Links ICH stability guidelines and climatic variability to precise storage statements;</p> </ItemContent> <ItemContent> <p> Proposes harmonised core label phrases for room temperature, fridge, and freezer;</p> </ItemContent> <ItemContent> <p>Introduces contingency labelling for climate-related and cold-chain excursions.</p> </ItemContent> </UnorderedList></p>

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Reassessing and Updating Regulatory Standards on the Declaration of Storage Conditions in the Product Information of Medicinal Products: An Evidence-Based Proposal under EMA Guidance

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月20日

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  • Helena Pericão,
  • Henrique Cavaco,
  • Miguel Dias,
  • Luís Sarmento,
  • Mário Magalhães,
  • Bernardo Filipe,
  • Herivelto Vieira,
  • João Rita,
  • Pedro Gonçalves,
  • Matilde Vaz,
  • Beatriz Coimbra,
  • Beatriz Monteiro,
  • Beatriz Gomes,
  • Cátia Josué,
  • Ecaterina Fuior,
  • Lara Penso,
  • Maria Ferreira,
  • Maria Leonor Forjaz,
  • Rodrigo Neves,
  • Sofia Azevedo,
  • Constança Lopes,
  • Sofia Rosário,
  • Rita Leal,
  • Pia Erjavec,
  • Felipe Lima,
  • Rui Loureiro,
  • Gracinda M. M. Sanches-Fernandes

摘要

Purpose

The European Medicines Agency (EMA) guideline Declaration of Storage Conditions in the Product Information of Medicinal Products (CPMP/QWP/609/96/Rev.2) was last revised in 2007. Since then, advances in stability science, increased climatic variability, and evolving regulatory expectations have highlighted limitations in the framework, particularly the use of vague descriptors such as “room temperature” or “no special storage conditions.” This work reassesses the scientific and regulatory basis for storage statements, integrating current understanding of mean kinetic temperature (MKT), climate-related risks, and developments in ICH and WHO guidance, and proposes a harmonized revision (Rev.3).

Methods

A structured analysis of regulatory and scientific principles was conducted, incorporating MKT, climate-related risks, and developments in ICH and WHO guidance. These elements informed a revised framework and model storage statements, including a decision table linking stability outcomes to label statements.

Results

The proposed update introduces explicit temperature-based statements, strengthens the linkage between stability data and label wording, clarifies requirements for moisture- and light-sensitive products, expands guidance for sterile and reconstituted preparations, and provides contingency instructions for temperature excursions. A decision table mapping stability outcomes to label statements is included to support regulatory implementation.

Conclusion

This revision provides an updated synthesis of EMA, ICH, and WHO requirements, translating regulatory principles into clear storage statements and contingency guidance. It offers a more precise framework reducing ambiguity, supports justification of storage conditions through stability data and MKT-informed risk assessment, aiming to improve understanding among patients and healthcare professionals, strengthening real-world product quality and contributing to future EMA guideline development.

Highlights

Identifies scientific and regulatory limitations in current “no special storage conditions” terminology;

Links ICH stability guidelines and climatic variability to precise storage statements;

Proposes harmonised core label phrases for room temperature, fridge, and freezer;

Introduces contingency labelling for climate-related and cold-chain excursions.