
Academic Journal
Q1Therapeutic Innovation and Regulatory Science
About Therapeutic Innovation and Regulatory Science
Therapeutic Innovation and Regulatory Science is a scholarly journal published by Springer Science and Business Media Deutschland GmbH. SCImago 2025 lists it in Q1, with an SJR of 0.902 and H-index of 57.
Coverage: 1970, 1972, 1974-2006, 2008-2011, 2013-2026. Research categories: Pharmacology, Toxicology and Pharmaceutics (miscellaneous) (Q1); Public Health, Environmental and Occupational Health (Q1); Pharmacology (medical) (Q2).
Verified field sources
- Journal Impact Factor: 2.1 — Official source; checked 2026-10-03. Journal metric year and editorial leadership as listed on the Springer Nature journal homepage.
- Impact Factor year: 2025 — Official source; checked 2026-10-03. Journal metric year and editorial leadership as listed on the Springer Nature journal homepage.
Source-backed journal facts
Topics in published research
Health Systems, Economic Evaluations, Quality of Life; Statistical Methods in Clinical Trials; Pharmaceutical Economics and Policy; Biomedical Ethics and Regulation; Ethics in Clinical Research; Pharmaceutical studies and practices.
OpenAlex classifies topics from published works. These topics are not the publisher’s official aims and scope.
Reported open-access list prices
4,090.00 USD; 3,090.00 EUR; 2,690.00 GBP
APC list prices reported by OpenAlex, which obtains this information from DOAJ. Confirm current charges, taxes, waivers and eligibility with the publisher; this is not a fee quotation.
Source: OpenAlex source record. Retrieved 2026-10-03. Source record updated 2026-10-02. OpenAlex metrics are different from SCImago metrics and the Clarivate Journal Impact Factor.
Journal Metrics
Quartile, SJR and the listed SCImago H-index use the 2025 imported SCImago dataset. A quartile may vary by subject category. Values without a source or reporting year are unverified historical entries. Verify the current Journal Impact Factor with Clarivate or the publisher before using it.
Aims & Scope
The publisher’s official aims and scope have not yet been verified for this profile. Use the journal website to check subject fit and accepted article types before submitting.
Recent Research Articles
Latest publications matched automatically by ISSN.
Common Deficiencies in Dossiers of Finished Pharmaceutical Products Submitted for Registration and Related Factors: A Mixed-Method Study in Tanzania
Francis Kittinga, Betty Maganda, Eulambius Mlugu, Stanley Mwita et al.
2026-10-03 · DOI: 10.1007/s43441-026-01053-4Analysis of IMPD Deficiencies in the Clinical Trial Approval Process
Sanja Arsić
2026-09-17 · DOI: 10.1007/s43441-026-01046-3Lean–Agile Product Development in FDA Relevant and Regulated Medical Device Contexts
Alliy Adewale Bello, Kelvin Ebo Rabbles, Victor Osemudiame, Benny Uhoranishema et al.
2026-09-15 · DOI: 10.1007/s43441-026-01048-1Beyond prediction: an evidenced-based framework for assessing site selection decisions
Anh Ninh, Linh Vu, Daniel Butler
2026-09-12 · DOI: 10.1007/s43441-026-01043-6Current Landscape of Investigator-Initiated Decentralized Clinical Trials in Japan: A Nationwide Survey
Yuko Kobayakawa, Kouta Funakoshi, Kenichi Kohno, Yasuko Ikeda-Sakai et al.
2026-09-12 · DOI: 10.1007/s43441-026-01045-4Contribution of Real-World Evidence for the Orphan Medicines Approvals in the European Union Between 2000 and 2025
Luísa Bouwman, Diogo Almeida, Carla Jonker, Hubert Leufkens et al.
2026-09-09 · DOI: 10.1007/s43441-026-01044-5Publisher Correction: Review Performance of New Active Substances in Taiwan: A 10-Year Retrospective Analysis (2015–2024)
Chun-Yi Huang, Ling-Kuei Chen, Bi-Kai Hsu, Hwei-Fang Cheng et al.
2026-09-07 · DOI: 10.1007/s43441-026-01042-7Environmental Risk Assessment in Pharmaceutical Regulation: A Comparative Review of EMA, U.S. FDA and CDSCO Guidelines
A. S. Sheena, R. S. Rajesh, Fairoosa Thaikkat
2026-09-03 · DOI: 10.1007/s43441-026-01035-6Review Performance of New Active Substances in Taiwan: A 10-Year Retrospective Analysis (2015–2024)
Chun-Yi Huang, Ling-Kuei Chen, Bi-Kai Hsu, Hwei-Fang Cheng et al.
2026-09-01 · DOI: 10.1007/s43441-026-01038-3Characteristics of Authorized Clinical Trials in Peru, 2017–2025: A National Registry-Based Study
Liz Mendoza-Aucaruri, Alexander Gabriel Acevedo-Cahuana, Fritzi Pilar Villalba-Ugarte, Luis Ttito-Paricahua et al.
2026-08-31 · DOI: 10.1007/s43441-026-01040-9Precision-Based Sample Size Determination: Implications for Decision-Making
Jiwei He, Taekwon Hong, Andrew Giffin, Rongmei Zhang et al.
2026-08-30 · DOI: 10.1007/s43441-026-01039-2Non-Oncology Biomarkers in Precision Medicine: A Narrative Review
Achilleas Livieratos, Laura Goea, Vivek Das, Marie-Karelle Riviere et al.
2026-08-29 · DOI: 10.1007/s43441-026-01041-8AI-Enabled Real-World Evidence in Oncology: A Statistical Perspective for Regulatory Decisions
Lei Gao, Dai Feng, Binbing Yu
2026-08-26 · DOI: 10.1007/s43441-026-01036-5Constructing an Evidence-Based Validity Rationale for a Multi-component Endpoint in Heterogeneous Populations
Bryce B. Reeve, Laine E. Thomas, Kevin P. Weinfurt
2026-08-22 · DOI: 10.1007/s43441-026-01037-4Patient-Reported Outcomes Used for Regulatory Approval of Medicines Indicated for the Treatment of Dermatological Diseases Authorized in the European Union Between 1998 and 2024
Eléonore Coenen, Diogo Almeida, Bruno Sepodes, Carla Torre et al.
2026-08-18 · DOI: 10.1007/s43441-026-01034-7Precision Lipid Management in the Era of Biotechnology and Artificial Intelligence: From Gene Editing to Smart Drug Delivery
Esra Palabiyik
2026-08-14 · DOI: 10.1007/s43441-026-01033-8Exploring the Polyethylene Glycol-Modified Drug Patent Landscape by Deep Learning
Tingting Zhang, Dechao Deng, Xiaoming Zhang, Weijie Chen et al.
2026-08-13 · DOI: 10.1007/s43441-026-01032-9Defining a Clinically Meaningful Within-Person Change Threshold for the Psychomotor Vigilance Test in Narcolepsy Type 1
Brian T. Harel, Robert H. Pietrzak, Shruti Dave, Paul Maruff et al.
2026-08-10 · DOI: 10.1007/s43441-026-01025-8BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity
Kai Chen, Yixuan Zhao, Kentaro Takeda, Ying Yuan et al.
2026-08-10 · DOI: 10.1007/s43441-026-00994-0Psychotropic Drug Scheduling and Benzodiazepine Receptor Agonist Prescribing in Japan: An Interrupted Time Series Analysis
Kota Tatsuoka, Shota Hamada, Sayuri Shimizu, Makoto Tomita et al.
2026-08-08 · DOI: 10.1007/s43441-026-01029-4Reviews
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Version History
October 4, 2026 at 9:01 pm
October 2, 2026