Therapeutic Innovation & Regulatory Science

Therapeutic Innovation & Regulatory Science (TIRS) is the official peer-reviewed scientific journal of the Drug Information Association (DIA), published bimonthly by Springer Nature. It carries a Clarivate Journal Impact Factor of 2.1 (with a 5-year Impact Factor of 2.1) in the Science Citation Index Expanded, serving as a primary academic forum for biopharmaceutical product development, clinical trial methodology, and global regulatory policy.

ByCASRAI Editorial Board

· Last updated 7 Nov 2026

What Therapeutic Innovation & Regulatory Science Measures and Covers

Therapeutic Innovation & Regulatory Science (NLM ID: 101597411, Medline abbreviation: Ther Innov Regul Sci) is an international peer-reviewed journal published six times per year. Originally launched in 1967 as the Drug Information Bulletin and subsequently known for decades as the Drug Information Journal, the publication adopted its current title in January 2013 under volume 47. Formerly published by Sage Publications, the journal has been published by Springer International Publishing (part of Springer Nature) since 2020.

The journal focuses on the intersection of biomedical science, biostatistics, pharmaceutical policy, and regulatory administration. Key coverage areas include:

Clinical Trial Design and Methodology: Complex innovative trial designs, adaptive protocols, master protocols, and decentralized trial execution.
Regulatory Harmonization and Policy: Practical implementation of International Council for Harmonisation (ICH) guidelines, including sponsor oversight under ICH E6(R3) and GCP quality management.
Biostatistics and Data Standards: Estimands, real-world data (RWD), real-world evidence (RWE), and statistical modeling for regulatory submissions.
Outsourcing and Operational Governance: Sponsor-vendor relationships and governance models relevant to our clinical trial outsourcing decision framework and sponsor vs CRO operations.

Journal Citation Metrics and Calculation

In Clarivate’s Web of Science Core Collection, TIRS is indexed in the Science Citation Index Expanded (SCIE) under the subject categories Pharmacology & Pharmacy and Medical Informatics. Its current primary citation metrics include:

Two-Year Journal Impact Factor: 2.1. This metric is calculated by dividing the total citations received in the JCR evaluation year to citable items (original research articles and review papers) published by TIRS during the two preceding calendar years by the total number of citable items published during those same two years.
Five-Year Impact Factor: 2.1. This measures the ratio of citations received in the evaluation year to articles published across the preceding five years, offering a broader citation horizon that accounts for the longer adoption timelines typical of regulatory and clinical policy research.
Standard Identifiers: Print ISSN 2168-4790; Electronic ISSN 2168-4804.

Interpreting TIRS Metrics and Responsible Evaluation

While an Impact Factor of 2.1 situates TIRS as an established, specialist publication in regulatory affairs and drug development science, authors and research evaluators should apply responsible assessment principles in line with the San Francisco Declaration on Research Assessment (DORA) and the Leiden Manifesto:

Disciplinary Specificity: Regulatory science and clinical methodology journals operate within a specialized policy ecosystem. Citation velocity in this field differs substantially from basic molecular biology or general medical mega-journals (such as detailed in our guide to Scientific Reports impact factor metrics). A JIF of 2.1 reflects steady citation by regulatory practitioners, biostatisticians, and clinical trial sponsors.
Avoid Journal-Level Proxies: Journal impact factors represent an aggregate mathematical mean of citations across all articles. Highly cited regulatory white papers skew the mean, meaning that a journal-level metric should never serve as a proxy for the quality, regulatory validity, or methodology of an individual clinical trial protocol or study.
Holistic Performance Context: Evaluators should assess individual contributions based on regulatory uptake, citations in health authority guidance documents (e.g., FDA, EMA, PMDA), and methodological robustness rather than relying solely on citation index scores.

Sources

National Library of Medicine. “Therapeutic Innovation & Regulatory Science.” NLM Catalog Record, NLM ID 101597411, 2026. Read November 7, 2026. https://www.ncbi.nlm.nih.gov/nlmcatalog/101597411
Clarivate. “Journal Citation Reports: Therapeutic Innovation & Regulatory Science.” Web of Science Master Journal List, SCIE, 2026. Read November 7, 2026. https://mjl.clarivate.com/
Drug Information Association (DIA). “Therapeutic Innovation & Regulatory Science (TIRS) Official Journal.” DIA Global Resources, 2026. Read November 7, 2026. https://www.diaglobal.org/

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