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Abstract

The worldwide market for over-the-counter (OTC) medications is quickly developing, providing consumers with increased self-medication options while facing substantial regulatory issues due to varied approval procedures, labeling regulations, and safety standards between nations. Despite efforts to standardize regulatory frameworks, differences in component classification, dosage limitations, and risk assessment standards impede producers, healthcare professionals, and lawmakers. This analysis looks at the regulatory environment of over-the-counter pharmaceuticals in major countries, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and regulatory organizations in Asia-Pacific and developing economies, highlighting notable disparities in approval procedures, marketing authorization, and pharmacovigilance. Consumer safety is one of the most important problems in regulatory divergence, since differences in authorized active ingredients, warnings, and recalls can lead to abuse, adverse medication responses, and cross-border product availability anomalies. Furthermore, the lack of standardized testing and quality control procedures hampers international trade and public health policy. Emerging threats, such as antimicrobial resistance (AMR), counterfeit OTC goods, and digital health breakthroughs, necessitate a more integrated and adaptable global regulatory framework. This assessment also looks at continuing harmonization efforts by organizations such as the International Council for Harmonization (ICH) and the World Health Organization (WHO), as well as best practices for expediting global regulatory procedures. Addressing regulatory divergence with data-driven decision-making, digital pharmacovigilance, and risk-based categorization frameworks can help enhance consumer safety, market efficiency, and public health outcomes. The future of over-the-counter medication regulation lies in collaborative policymaking, real-time safety monitoring, and rapid adaptability to changing healthcare concerns.

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2025-07-03
2025-10-19

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References

  1. Andy Adinarayana Andy Divya Tharayil Aman Suresh The Role of pharmacists in ensuring the safe and effective use of over-the-counter (OTC) products in retail pharmacies. Inter. J. Multidiscipl. Res. 2024 6 2 1 9
    [Google Scholar]
  2. Nonprescription drug product with an additional condition for nonprescription use. 2024 Available from: https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/nonprescription-drug-product-additional-condition-nonprescription-use
  3. Legal framework. 2019 Available from: https://www.ema.europa.eu/en/about-us/what-we-do/legal-framework#:~:text=Marketing%20authorisation%20transfer,the%20transfer%20of%20marketing%20authorisations
  4. Global campaign to phase out over-the-counter (OTC) antibiotic sales consultation report. 2023 Available from: https://www.who.int/publications/m/item/global-campaign-to-phase-out-over-the-counter-(otc)-antibiotic-sales-consultation-report
  5. Algarni M. Hadi M.A. Yahyouche A. Mahmood S. Jalal Z. A mixed-methods systematic review of the prevalence, reasons, associated harms and risk-reduction interventions of over-the-counter (OTC) medicines misuse, abuse and dependence in adults. J. Pharm. Policy Pract. 2021 14 1 76 10.1186/s40545‑021‑00350‑7 34517925
    [Google Scholar]
  6. Ray I. Bardhan M. Hasan M.M. Sahito A.M. Khan E. Patel S. Jani I. Bhatt P.K. Sp R. Swed S. Over the counter drugs and self-medication worldwide paranoia and a troublesome situation in India during the COVID-19 pandemic. Ann. Med. Surg. 2022 78 103797 10.1016/j.amsu.2022.103797 35637885
    [Google Scholar]
  7. How FDA strives to ensure the safety of OTC products. 2016 Available from: https://www.fda.gov/drugs/special-features/how-fda-strives-ensure-safety-otc-products
  8. Information on medicinal products. 2015 Available from: https://toolbox.eupati.eu/resources/information-on-medicinal-products/
  9. Sharma A.K. Shrivastava T.P. Singh M.A. Ahuja J. Goyal R.K. Regulations in India. In: Global Regulations of Medicinal, Pharmaceutical, and Food Products. CRC Press 2024 133 152
    [Google Scholar]
  10. Australian Regulatory Guidelines for OTC Medicines (ARGOM). 2025 Available from: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-otc-medicines-argom
  11. A comparison of OTC status of medicines across Europe. 2016 Available from: https://clarivate.com/life-sciences-healthcare/lp/a-comparison-of-otc-status-of-medicines-across-europe/
  12. Narang P. Garg V. Sharma A. Regulatory, safety and economic considerations of over-the-counter medicines in the Indian population. Discov Health Syst. 2023 2 1 17 10.1007/s44250‑023‑00032‑y
    [Google Scholar]
  13. Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers. 2021 Available from: https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers
  14. Makrani MF Goyal A Sayeed SY A comparative overview of global regulatory authorities: Ensuring quality, safety, and efficacy in medicines.
    [Google Scholar]
  15. Rajput H Raikwar MA The Center for Drug Evaluation and Research uses different requirements for the three main drug product.
    [Google Scholar]
  16. Sng Y.J. Kwok D. Goh E. Tan A. Teo J. Chan C.L. The problems with online health product sales: How can regulations be improved? Drug Saf. 2024 47 6 529 533 10.1007/s40264‑024‑01414‑8 38483769
    [Google Scholar]
  17. International regulatory harmonization. 2025 Available from: https://www.fda.gov/drugs/cder-international-program/international-regulatory-harmonization
  18. Regulatory harmonization. 2014 Available from: https://iris.who.int/bitstream/handle/10665/331132/DI281-3-10-eng.pdf
  19. Willink A. Assi L. Nieman C. McMahon C. Lin F.R. Reed N.S. Alternative pathways for hearing care may address disparities in access. Front. Digit. Health 2021 3 740323 10.3389/fdgth.2021.740323 34901925
    [Google Scholar]
  20. López Vila E.D. Buts C. Jegers M. A quantitative classification of OTC medicines regulations in 30 European countries: Dispensing restrictions, distribution, pharmacy ownership, and pricing systems. J. Pharm. Policy Pract. 2023 16 1 19 10.1186/s40545‑023‑00522‑7 36717949
    [Google Scholar]
  21. Limbu Y.B. Huhmann B.A. Online but unlawful sales of unapproved and misbranded prescription drugs: Internet pharmacy compliance with Food and Drug Administration warning letters. J. Consum. Aff. 2023 57 3 1015 1038 10.1111/joca.12515
    [Google Scholar]
  22. Dcruz A.C. Mokashi V.N. Pai S.R. Sreedhar D. The rise of E-pharmacy in India. Indian J. Pharmacol. 2022 54 4 282 291 10.4103/ijp.ijp_445_21 36204812
    [Google Scholar]
  23. Kumaran H. Long C.S. Bakrin F.S. Tan C.S. Goh K.W. Al-Worafi Y.M. Lee K.S. Lua P.L. Ming L.C. Online pharmacies: Desirable characteristics and regulations. Drugs Ther. Perspect. 2020 36 6 243 245 10.1007/s40267‑020‑00727‑9
    [Google Scholar]
  24. Taylor J.G. Ayosanmi S. Sansgiry S.S. Consumer impressions of the safety and effectiveness of OTC medicines. Pharmacy 2023 11 2 51 10.3390/pharmacy11020051 36961029
    [Google Scholar]
  25. New Drug Application (NDA). 2022 Available from: https://www.fda.gov/drugs/types-applications/new-drug-application-nda#:~:text=Introduction,strength%2C%20quality%2C%20and%20purity
  26. Small business assistance: Frequently asked questions on the regulatory process of over-the-counter (otc) drugs. 2022 Available from: https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-regulatory-process-over-counter-otc-drugs#switch https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
  27. Available from: https://www.cnbctv18.com/india/healthcare/cdsco-forms-sub-committee-to-revise-guidelines-for-over-the-counter-drugs-19412493.html
  28. Chesney E. McGuire P. Freeman T.P. Strang J. Englund A. Lack of evidence for the effectiveness or safety of over-the-counter cannabidiol products. Ther. Adv. Psychopharmacol. 2020 10 2045125320954992 10.1177/2045125320954992 32973998
    [Google Scholar]
  29. Akande-Sholabi W. Akinyemi O.O. Self-medication with over-the-counter drugs among consumers cross-sectional survey in a Southwestern State in Nigeria. BMJ Open 2023 13 5 e072059 10.1136/bmjopen‑2023‑072059 37202127
    [Google Scholar]
  30. Kotwani A. Joshi J. Lamkang A.S. Over-the-counter sale of antibiotics in India qualitative study of providers’ perspectives across two states. Antibiotics 2021 10 9 1123 10.3390/antibiotics10091123 34572705
    [Google Scholar]
  31. Ylä-Rautio H. Siissalo S. Leikola S. Drug-related problems and pharmacy interventions in non-prescription medication, with a focus on high-risk over-the-counter medications. Int. J. Clin. Pharm. 2020 42 2 786 795 10.1007/s11096‑020‑00984‑8 32078108
    [Google Scholar]
  32. Schifano F. Chiappini S. Miuli A. Mosca A. Santovito M.C. Corkery J.M. Guirguis A. Pettorruso M. Di Giannantonio M. Martinotti G. Focus on over-the-counter drugs’ misuse systematic review on antihistamines, cough medicines, and decongestants. Front. Psychiatry 2021 12 657397 657397 10.3389/fpsyt.2021.657397 34025478
    [Google Scholar]
  33. Karłowicz-Bodalska K. Sauer N. Over the counter pain medications used by adults: a need for pharmacist intervention. Int. J. Environ. Res. Public Health 2023 20 5 4505 10.3390/ijerph20054505
    [Google Scholar]
  34. Schjerning A.M. McGettigan P. Gislason G. Cardiovascular effects and safety of (non-aspirin) NSAIDs. Nat. Rev. Cardiol. 2020 17 9 574 584 10.1038/s41569‑020‑0366‑z 32322101
    [Google Scholar]
  35. Bindu S. Mazumder S. Bandyopadhyay U. Non-steroidal anti-inflammatory drugs (NSAIDs) and organ damage current perspective. Biochem. Pharmacol. 2020 180 1 114147 10.1016/j.bcp.2020.114147 32653589
    [Google Scholar]
  36. Taneja S Suri B Gupta K Gupta I Kaur S. Exploring the factors behind otc drug abuse: A data-driven approach. Advances in Artificial-Business Analytics and Quantum Cham Springer 2024 1 8 10.1007/978‑981‑97‑2508‑3_60
    [Google Scholar]
  37. Wang G.S. Reynolds K.M. Banner W. Bond G.R. Kauffman R.E. Palmer R.B. Paul I.M. Rapp-Olsson M. Green J.L. Dart R.C. Adverse events related to accidental unintentional ingestions from cough and cold medications in children. Pediatr. Emerg. Care 2022 38 1 e100 e104 10.1097/PEC.0000000000002166 32576790
    [Google Scholar]
  38. Głowacka K. Wiela-Hojeńska A. Pseudoephedrine-benefits and risks. Int. J. Mol. Sci. 2021 22 10 5146 10.3390/ijms22105146 34067981
    [Google Scholar]
  39. Lehnbom E.C. Berbakov M.E. Hoffins E.L. Moon J. Welch L. Chui M.A. Elevating safe use of over-the-counter medications in older adults narrative review of pharmacy involved interventions and recommendations for improvement. Drugs Aging 2023 40 7 621 632 10.1007/s40266‑023‑01041‑5 37340207
    [Google Scholar]
  40. Gilson A.M. Xiong K.Z. Stone J.A. Jacobson N. Chui M.A. A pharmacy-based intervention to improve safe over-the-counter medication use in older adults. Res. Social Adm. Pharm. 2020 32444347
    [Google Scholar]
  41. Sánchez-Sánchez E. Fernández-Cerezo F.L. Díaz-Jimenez J. Rosety-Rodriguez M. Díaz A.J. Ordonez F.J. Rosety M.Á. Rosety I. Consumption of over-the-Counter drugs: Prevalence and type of drugs. Int. J. Environ. Res. Public Health 2021 18 11 5530 10.3390/ijerph18115530 34064096
    [Google Scholar]
  42. Yu Y.B. Briggs K.T. Taraban M.B. Preventive pharmacovigilance: Timely and precise prevention of adverse events through person-level patient screening and dose-level product surveillance. Pharm. Res. 2023 40 9 2103 2106 10.1007/s11095‑023‑03548‑3 37349651
    [Google Scholar]
  43. Alomar M. Tawfiq A.M. Hassan N. Palaian S. Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: Current status, challenges and the future. Ther. Adv. Drug Saf. 2020 11 2042098620938595 10.1177/2042098620938595 32843958
    [Google Scholar]
  44. Amatya E. Fois R. Williams K.A. Pont L.G. Potential for detection of safety signals for over-the-counter medicines using national ADR spontaneous reporting data: The example of OTC NSAID-associated gastrointestinal bleeding. Pharmacy 2020 8 3 174 10.3390/pharmacy8030174 32957485
    [Google Scholar]
  45. Dunn J. Schifano F. Dudley E. Guirguis A. Exploring human misuse and abuse of veterinary drugs descriptive pharmacovigilance analysis utilising the food and drug administration’s adverse events reporting system (FAERS). Toxics 2024 12 11 777 7 10.3390/toxics12110777 39590957
    [Google Scholar]
  46. Liang Z. Hu H. Li J. Yao D. Wang Y. Ung C.O.L. Advancing the regulation of traditional and complementary medicine products: A comparison of five regulatory systems on traditional medicines with a long history of use. Evid Based Complement Alternat Med. 2021 2021 5833945 10.1155/2021/5833945
    [Google Scholar]
  47. Yoffe A. Liu J. Smith G. Chisholm O. Regulatory reform outcomes and accelerated regulatory pathways for new prescription medicines in Australia. Ther Innov Regul Sci. 2023 57 2 271 286 10.1007/s43441‑022‑00465‑2 36271207
    [Google Scholar]
  48. Diantini A. Alfaqeeh M. Permatasari L. Nurfitriani M. Durotulailah L. Wulandari W. Sitorus T. Wilar G. Levita J. Clinical toxicology of OTC cough and cold pediatric medications narrative review. Pediatric Health Med. Ther. 2024 15 243 255 10.2147/PHMT.S468314 39011322
    [Google Scholar]
  49. Pietrusiewicz M. Kopa-Stojak P.N. Pawliczak R. Pharmacist’s recommendations of over-the-counter treatments for the common cold - Analysis of prospective cases in Poland. BMC Fam. Pract. 2021 22 1 216 10.1186/s12875‑021‑01561‑2 34717562
    [Google Scholar]
  50. Jaeschke H. Akakpo J.Y. Umbaugh D.S. Ramachandran A. Novel therapeutic approaches against acetaminophen-induced liver injury and acute liver failure. Toxicol. Sci. 2020 174 2 159 167 10.1093/toxsci/kfaa002 31926003
    [Google Scholar]
  51. Narla S. Lim H.W. Sunscreen: FDA regulation, and environmental and health impact. Photochem. Photobiol. Sci. 2020 19 1 66 70 10.1039/c9pp00366e 31845952
    [Google Scholar]
  52. Regulation of over-the-counter drug products should be streamlined. 2017 Available from: https://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2017/03/regulation-of-over-the-counter-drug-products-should-be-streamlined
  53. Adams AJ Frost TP The over‐regulation of pharmacist services: Why over‐the‐counter naloxone should spark conversation about a “standard of care” regulatory approach. JACCP: J. American Coll. Clin. Pharm. 2023 6 6 615 620 10.1002/jac5.1794
    [Google Scholar]
  54. Bansal R. Dhiman A. Nutraceuticals Comparative Analysis of Regulatory Framework in Different Countries of the World. Endocr. Metab. Immune Disord. Drug Targets 2020 20 10 1654 1663 10.2174/1871530320666200519084415 32427089
    [Google Scholar]
  55. Ino H. Nakazawa E. Over-the-counter drug misuse and dependence: Public health ethics’ foray into fight against the codeine crisis. Pharmacy 2022 10 6 155 10.3390/pharmacy10060155 36412831
    [Google Scholar]
  56. Regulation of cross-border OTC derivatives activities: Finding the middle ground. 2013 Available from: https://www.sec.gov/newsroom/speeches-statements/2013-spch040613ebwhtm
  57. Feeney A.J. Goad J.A. Flaherty G.T. Global perspective of the risks of falsified and counterfeit medicines critical review of the literature. Travel Med. Infect. Dis. 2024 61 102758 8 10.1016/j.tmaid.2024.102758 39218049
    [Google Scholar]
  58. Pashkov V Soloviov O Harkusha A. Digital marketing: problems of internet pharmacies legal regulation. Facul. Law Elect. Scient. J. Law 2021 3 21 191 203 10.25143/socr.21.2021.3.191‑203
    [Google Scholar]
  59. Lockwood E. From bombs to boons: Changing views of risk and regulation in the pre-crisis OTC derivatives market. Theory Soc. 2020 49 2 215 244 10.1007/s11186‑020‑09386‑1
    [Google Scholar]
  60. Cross-border fragmentation of global OTC derivatives: An empirical analysis. 2014 Available from: https://www.isda.org/a/cSiDE/cross-border-fragmentation-an-empirical-analysis.pdf
  61. Schinasi G. J. Safeguarding financial stability. Theory Pract. 2005 1 9 10.5089/9781589064409.071
    [Google Scholar]
  62. Ahmed J. Modica de Mohac L. Mackey T.K. Raimi-Abraham B.T. A critical review on the availability of substandard and falsified medicines online: Incidence, challenges and perspectives. J. Med. Access 2022 6 23992026221074548 10.1177/23992026221074548 36204527
    [Google Scholar]
  63. Ammerdorffer A. Laws M. Awiligwe A. Erb F. Im-Amornphong W. Gülmezoglu A.M. Chinery L. Lucido B. Narasimhan M. Regulatory standards and processes for over-the-counter availability of hormonal contraception and drugs for medical abortion in five countries in the Eastern Mediterranean Region. Health Res. Policy Syst. 2021 19 S1 Suppl. 1 51 10.1186/s12961‑020‑00661‑2 33882941
    [Google Scholar]
  64. Geyikçi U.B. Özyıldırım S. Deviations from covered interest parity in the emerging markets after the global financial crisis. J. Int. Financ. Mark. Inst. Money 2023 85 101765 10.1016/j.intfin.2023.101765
    [Google Scholar]
  65. Alenezi S. Alanazi M. Aljazaeri R. Almuzaini M. Alrasheidi S. Shamlan W.B. Aljohani R. Alhawiti G. Alqarni M. Aljabri E. Qmmash M. Kanan M. Community pharmacies in the asian countries of developing health system: Formation, regulation, and implication. Pharmacy 2023 11 4 127 10.3390/pharmacy11040127 37624082
    [Google Scholar]
  66. Barman P. Thukral T. Chopra S. Communication with physicians tool for improving appropriate antibiotic use in the absence of regulatory mechanisms. Curr. Treat. Options Infect. Dis. 2021 13 1 1 13 10.1007/s40506‑020‑00241‑6
    [Google Scholar]
  67. Kamba P.F. Nambatya W. Aguma H.B. Charani E. Rajab K. Gaps and opportunities in sustainable medicines use in resource limited settings situational analysis of Uganda. Br. J. Clin. Pharmacol. 2022 88 9 3936 3942 10.1111/bcp.15324 35342977
    [Google Scholar]
  68. Hassen H.K. Mekasha Y.T. Tegegne A.A. Ozalp Y. A narrative review on problems in product quality, regulatory system constraints, and the concept of quality by design as a solution for quality assurance of African medicines. Front. Med. 2024 11 1472495 10.3389/fmed.2024.1472495 39421861
    [Google Scholar]
  69. Marathe P.A. Kamat S.K. Tripathi R.K. Raut S.B. Khatri N.P. Over-the-counter medicines. J. Postgrad. Med. 2020 66 1 28 34 10.4103/jpgm.JPGM_381_19 31898596
    [Google Scholar]
  70. Ramírez-Telles M. Argotti-Rodríguez U. Regulation of drug prescribing information in latin america and the caribbean. Ther. Innov. Regul. Sci. 2022 56 4 536 551 10.1007/s43441‑022‑00396‑y 35380375
    [Google Scholar]
  71. Available from: https://www.eximbankindia.in/Assets/Dynamic/PDF/PublicationResources/ResearchPapers/92file.pdf
  72. Huynh‐Ba K. Good manufacturing practices (GMPs) and the quality systems. Analyt. Test. Pharma. GMP Laborat. 2022 9 26 56
    [Google Scholar]
  73. Sharma B. Gurung A. Pradhan P. Darjee D. Kotla N.K. Navigating the regulatory landscape: Key trends shaping today’s regulatory affairs environment. Int. J. Drug Regul. Aff. 2023 11 4 87 92 10.22270/ijdra.v11i4.639
    [Google Scholar]
  74. Personal Importation. 2024 Available from: https://www.fda.gov/industry/import-basics/personal-importation#:~:text=Foreign%20Nationals:Copy%20of%20Prescription%20(in%20English)
  75. Indrayanto G. Regulation and standardization of herbal drugs: Current status, limitation, challenge’s and future prospective. Profiles Drug Subst. Excip. Relat. Methodol. 2024 49 153 199 10.1016/bs.podrm.2023.11.003 38423707
    [Google Scholar]
  76. Pezoulas VC Fotiadis DI The pivotal role of data harmonization in revolutionizing global healthcare: A framework and a case study. Conn. Health Telemed. 2024 3 300004 10.20517/chatmed.2023.37
    [Google Scholar]
  77. Raut N Bajaj K Matte P Building bridges: Harmonization efforts for enhanced collaboration between developed and developing countries. Int. J. Drug Reg. Affairs 2023 11 3 68 69
    [Google Scholar]
  78. Desai M. Njoku A. Nimo-Sefah L. Comparing environmental policies to reduce pharmaceutical pollution and address disparities. Int. J. Environ. Res. Public Health 2022 19 14 8292 10.3390/ijerph19148292 35886145
    [Google Scholar]
  79. Gostin L.O. Wood A.J. Cuff P.A. Regulating medicines in a globalized world with increased recognition and reliance among regulators. JAMA 2020 324 2 145 146 10.1001/jama.2019.21793 32134427
    [Google Scholar]
  80. Bhavna O.A. International Council for Harmonisation (ICH) guidelines. Regulatory Affairs in the Pharmaceutical Industry 2022 47 74
    [Google Scholar]
  81. Siji-Fasole K. Self -Regulation of Derivatives: The Role of ISDA. Rochester, NY Social Science Research Network 2023
    [Google Scholar]
  82. Shamim M.A. Shamim M.A. Arora P. Dwivedi P. Artificial intelligence and big data for pharmacovigilance and patient safety. Journal of Medicine, Surgery, and Public Health 2024 3 Sep 100139 10.1016/j.glmedi.2024.100139
    [Google Scholar]
  83. OTC PharmaceuticalMarketing Trends. Available from: https://www.snipp.com/otc-pharmaceutical-marketing-trends
  84. Almond S.A.M. Warren M.J. Shealy K.M. Threatt T.B. Ward E.D. A systematic review of the efficacy and safety of over-the-counter medications used in older people for the treatment of primary insomnia. Sr. Care Pharm. 2021 36 2 83 92 10.4140/TCP.n.2021.83 33509331
    [Google Scholar]
  85. Mirdad Abeer Hussain Farookh Khadeer Hussain Omar Khadeer A systematic literature review on pharmaceutical supply chain: Research gaps and future opportunities. Inter. J. Web Grid Servic. 2023 19 2 1 9 10.1504/IJWGS.2023.131243
    [Google Scholar]
  86. Oleszkiewicz P. Krysinski J. Religioni U. Merks P. Access to medicines via non-pharmacy outlets in european countries—a review of regulations and the influence on the self-medication phenomenon. Healthcare 2021 9 2 123 10.3390/healthcare9020123 33530630
    [Google Scholar]
  87. Davis R. Griffith T. Van Ness B. Van Ness R. Modern OTC market structure and liquidity: The tale of three tiers. J. Financ. Mark. 2023 64 Jan 100815 10.1016/j.finmar.2023.100815
    [Google Scholar]
  88. A. N. C Mishra S. M. A Venkatesh M.P. Enhancing OTC monograph drug regulation through user fee program. Int J Pharm Pharm Sci. 2024 16 5 1 6
    [Google Scholar]
  89. OTC Drug Review Process | OTC Drug Monographs. 2023 Available from: https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs
  90. Franco P. Jain R. Rosenkrands-Lange E. Hey C. Koban M.U. Regulatory pathways supporting expedited drug development and approval in ICH member countries. Ther. Innov. Regul. Sci. 2022 36463352
    [Google Scholar]
  91. Gerlach N. Michiels-Corsten M. Viniol A. Schleef T. Junius-Walker U. Krause O. Donner-Banzhoff N. Professional roles of general practitioners, community pharmacists and specialist providers in collaborative medication deprescribing - a qualitative study. BMC Fam. Pract. 2020 21 1 183 10.1186/s12875‑020‑01255‑1 32887551
    [Google Scholar]
  92. Austin T.J. Comber S. Forrester E. Gardner M. Price O.R. Oldenkamp R. Ragas A.M.J. Hendriks A.J. The importance of over-the-counter-sales and product format in the environmental exposure assessment of active pharmaceutical ingredients. Sci. Total Environ. 2021 752 141624 10.1016/j.scitotenv.2020.141624 32892036
    [Google Scholar]
  93. Goetz K. Kalder M. Albert U.S. Jacke C.O. The usage of over-the-counter products by private insured patients in Germany – a claims data analysis with focus on complementary medicine. BMC Health Serv. Res. 2020 20 1 651 10.1186/s12913‑020‑05501‑1 32660646
    [Google Scholar]
  94. Dhanora M Sharma R Park WG Technological innovations and market power: a study of indian pharmaceutical industry. Millennial Asia 2020 12 1 1 5 10.1177/0976399620944272
    [Google Scholar]
  95. Saleem Anis M. Azmi Hassali M. Pharmaceutical marketing of over-the-counter drugs in the current digital era review. Pharmaceutical Sciences Asia 2022 49 2 114 120 10.29090/psa.2022.02.21.102
    [Google Scholar]
  96. Al-Worafi Y.M. Technology for drug safety: Challenges. Comput. Healthc. 2023 129 152
    [Google Scholar]
  97. Jo W. Nam H. Choi J. Opening the OTC drug market: The effect of deregulation on retail pharmacy’s performance. Int. J. Res. Mark. 2021
    [Google Scholar]
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Navigating Global Regulatory Divergence in Over-the-counter Drugs: Addressing Emerging Risks and Harmonization Challenges
Bentham Science Publishers ; https://doi.org/10.2174/0125899775370402250622155744
/content/journals/cdrr/10.2174/0125899775370402250622155744
/content/journals/cdrr/10.2174/0125899775370402250622155744
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  • Article Type:     Review Article
Keywords: safety standards ; regulatory compliance ; Global harmonization ; regulatory fragmentation ; non-prescription access ; efficacy validation

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