ArticleFrontiers in medicine2022
RNA-based drugs and regulation: Toward a necessary evolution of the definitions issued from the European union legislation.
Article in Frontiers in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- QbD product development: rapid optimization and scale-up of PBAE-based siRNA deliveryRSC pharmaceutics · 2026Article
- Synthesis of 2'-O,4'-Cα-Dimethyl Ribonucleoside Analogs and Their Effects on RNA and Modulation of ADAR Editing.Chemistry (Weinheim an der Bergstrasse, Germany) · 2026Article
- Regulatory Science: exploring an emerging scientific discipline in health care.Frontiers in medicine · 2026Article
- siRNA and mRNA-Based Preventive and Therapeutic Strategies for HPV-Induced Cervical Cancer.Advanced pharmaceutical bulletin · 2025Review
- "Snip, snip, cure"? Philosophical, legal and biomedical perspectives on novel somatic genomic therapies.Medicine, health care, and philosophy · 2025Article
- Pharmacoeconomic Profiles of Advanced Therapy Medicinal Products in Rare Diseases: A Systematic Review.Healthcare (Basel, Switzerland) · 2025Review
- Considerations for mRNA Product Development, Regulation and Deployment Across the Lifecycle.Vaccines · 2025Review
- mRNA-1273 is placenta-permeable and immunogenic in the fetus.Molecular therapy. Nucleic acids · 2025Article
- Circular RNA in hepatocellular carcinoma: emerging therapeutic strategies.Frontiers in immunology · 2025Review
- What's in a word? Defining "gene therapy medicines".Molecular therapy. Methods & clinical development · 2024Article
- Advancing Therapeutic and Vaccine Proteins: Switching from Recombinant to Ribosomal Delivery-A Humanitarian Cause.International journal of molecular sciences · 2024Review
- Targeting Lipoprotein(a): Can RNA Therapeutics Provide the Next Step in the Prevention of Cardiovascular Disease?Cardiology and therapy · 2024Review
- Breaking the mold with RNA-a "RNAissance" of life science.NPJ genomic medicine · 2024Review
- COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign.Cureus · 2024Review
- Anti-Idiotypic mRNA Vaccine to Treat Autoimmune Disorders.Vaccines · 2023Review
- mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues.International journal of molecular sciences · 2023Review
Corrections and comments
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Authors and funding
2 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Many RNA-based drugs, both vaccines and non-vaccines, are under development or even approved. They include coding mRNAs and non-coding (nc) RNAs among them antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), micro-RNAs (miRNAs), small activating RNAs (saRNAs), RNA aptamers and RNA guides. According to the European Union (EU) legislation, these products can be currently categorized into different regulatory statuses, depending, for vaccines, on their target (infectious disease or not) and, for other drugs, on how they are obtained (chemically or biologically). This classification is fundamental to the type of marketing authorization (MA), and therefore to the controls to be performed, from preclinical stages through clinical trials to pharmacovigilance, to meet the safety requirements for patients. However, the current rules raise several problems, in particular the risk, because technology is evolving, to have similar RNA drugs being covered by very different legal statuses and the lack of international harmonization. The objectives of this study are (i) to review how RNA medicinal products are currently legally categorized in the EU and especially whether they fall under the status of gene therapy medicinal products (GTMP), a regulatory status belonging to advanced therapy medicinal products (ATMP), (ii) to discuss the issues generated by this classification, with a focus on the heterogeneity of statuses of these products, the differences with the American and ICH definitions and the potential impact on the safety requirements.
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