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Bacteriophages [Phage] and their end products such\nas enzymes, virus-like particles, and vectors are being used for varied applications such as basic\nand applied research for the field of phage therapeutics. Phage-based products and services such\nas viral vectors for gene therapy\/vaccines, imaging agents, diagnostics as well as drug delivery\nagents form a wide range of useful innovative therapeutics that are under development. Regulatory\ncompliances are hence essential for safely implementing phage in varied applications.\nProduct compliances ensure safety, efficacy, stability, and quality control in preclinical as well\nas manufacturing and marketing processes. A well-established regulatory framework ensures\ninnovative product development with high rates of successful clinical translation and development\nof phage therapeutics as effective alternatives to antibiotics or for consideration in integrated\npathogen management strategies. This review highlights the importance of regulatory\nstandards in different stages of phage therapy- during preclinical research as well as different\nregulatory bodies in the manufacturing, clinical evaluation, and market approval of phage-based\nproducts. Global trends in facilitating phage therapeutics' regulatory frameworks and compliances\nare discussed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2174\/0113892010347488250113171505","type":"journal-article","created":{"date-parts":[[2025,1,23]],"date-time":"2025-01-23T01:23:43Z","timestamp":1737595423000},"page":"334-346","update-policy":"https:\/\/doi.org\/10.2174\/bsp_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Navigating Regulatory Frameworks and Compliances for Bacteriophages as Therapeutic Agents"],"prefix":"10.2174","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2196-7224","authenticated-orcid":true,"given":"Shilpa Deshpande","family":"Kaistha","sequence":"first","affiliation":[{"name":"Department of Biotechnology, School of Life Sciences &amp; Biotechnology, Chhatrapati Shahu Ji Maharaj University,Kanpur, 208024, UP, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pramila","family":"Devi","sequence":"additional","affiliation":[{"name":"Departmentof Microbiology, School of Life Sciences &amp; Biotechnology, Chhatrapati ShahuJi Maharaj University, Kanpur, 208024, UP, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nisha","family":"Sharma","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences, Chhatrapati Shahu Ji MaharajUniversity, Kanpur, 208024, UP, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sadhana","family":"Sagar","sequence":"additional","affiliation":[{"name":"Caliciviruses Section, Laboratory of Infectious Diseases, National Institute ofAllergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"965","reference":[{"key":"ref=1","doi-asserted-by":"publisher","first-page":"411","DOI":"10.1007\/978-1-0716-3549-0_24","volume":"2738","author":"Tumban E.","year":"2024","unstructured":"Tumban E.; Bacteriophage virus-like particles: Platforms for vaccine design. 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