Evidence map›Paper›PMID 42162533›Full record

ArticlePharmaceutical research2026

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.

Helena Pericão, Henrique Cavaco, Miguel Dias, Luís Sarmento, Mário Magalhães, Bernardo Filipe, Herivelto Vieira, João Rita, Pedro Gonçalves, Matilde Vaz and 17 more

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In one paragraph

Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Helena PericãoiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Henrique CavacoiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Miguel DiasiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Luís SarmentoiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Mário MagalhãesiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Bernardo FilipeiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Herivelto VieiraiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
João RitaiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Pedro GonçalvesiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Matilde VaziBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Beatriz CoimbraiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Beatriz MonteiroiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Beatriz GomesiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Cátia JosuéiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Ecaterina FuioriBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Lara PensoiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Maria FerreiraiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Maria Leonor ForjaziBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Rodrigo NevesiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Sofia AzevedoiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Constança LopesiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Sofia RosárioiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Rita LealiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Pia ErjaveciBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Felipe LimaiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal.
Rui LoureiroFaculdade de Farmácia, Universidade de Lisboa, Avenida Professor Gama Pinto, 1649-003, Lisbon, Portugal.
Gracinda M M Sanches-FernandesiBB, Institute for Bioengineering and Biosciences, Department of Bioengineering, Instituto Superior Técnico, Universidade de Lisboa, Avenida Rovisco Pais, 1049-001, Lisbon, Portugal. gracindasanches@tecnico.ulisboa.pt.ORCID http://orcid.org/0000-0003-1621-3855

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe 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).

methodsA 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.

resultsThe 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.

conclusionThis 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.

Indexed as

Drug StorageDrug LabelingDrug StabilityGuidelines as TopicHumansPharmaceutical PreparationsTemperaturePharmaceutical PreparationsEMA guidelineLabellingMedicinal productsStabilityStorage conditions

Identifiers

PMID42162533
PMCPMC13593696

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