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Open research questions in Pharmaceutical Quality and Counterfeiting

88 gap statements mined from Pharmaceutical Quality and Counterfeiting papers in our 4.5M-paper local library, which holds 464 papers on the topic — drawn mostly from each paper's own stated research gap, future-work, challenge and limitation notes, and its abstract. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one.

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What the literature leaves open

  • Substandard and falsified medicines are a concern in low- and middle-income countries. The quality of commercially available amlodipine tablet brands in Nigeria is unknown.

    QUALITY CONTROL ASSESSMENT OF THE COMMERCIALLY AVAILABLE AMLODIPINE TABLET BRANDS IN PORT HARCOURT, NIGERIA · 2026 · DOI

  • Future research will focus on conducting comparative analyses of the opportunities for implementing telepharmacy in Bulgaria in relation to other European Union Member States and countries worldwide to identify best practices and context-specific challenges.

    Telepharmacy as an innovative concept for the delivery of pharmaceutical services in Bulgaria · 2026 · DOI

  • The lack of real-time verification, fragmented inventory management, delayed shortage identification, and poor transparency in medicine distribution. The limitations of traditional pharmaceutical monitoring systems that rely heavily on manual inspection and fragmented databases.

    Pharma Watch AI: Counterfeit Medicine Detection and Shortage Prediction System · 2026 · DOI

  • Regulatory heterogeneity and limited capacity remain significant challenges. Restrictive pricing and reimbursement structures, insufficient real-world evidence guidance, and evolving intellectual property considerations also pose operational challenges.

    Advances in Regulatory Review Pathways in the Middle East: A Narrative Review of Reliance, Expedited Approvals, and Digitalization in Medicine Registration · 2026 · DOI

  • Lack of standardized workflows and automated tracking. Errors and redundancy in manual processing of applications.

    Web-based Dossier Management System (DMS) and Emerging Technologies to Facilitate Faster Registration and Access to Human Drugs: NAFDAC’s Experience · 2026 · DOI

  • The implementation of AI-enabled QA systems is hindered by regulatory barriers. The lack of standardized metadata and data integration creates challenges for AI-enabled QA systems. The processing of employee records and supplier information through AI systems creates potential privacy issues.

    STANDARDIZATION AND DATA INTEGRATION CHALLENGES IN AI-ENABLED PHARMACEUTICAL QUALITY ASSURANCE SYSTEMS: REGULATORY BARRIERS AND FUTURE DIRECTIONS · 2026 · DOI

  • Future research directions include the development of advanced regulatory frameworks and digital systems. Future research directions include the evaluation of the potential of AI and machine learning to enhance process efficiency and predictive analytics.

    STANDARDIZATION AND DATA INTEGRATION CHALLENGES IN AI-ENABLED PHARMACEUTICAL QUALITY ASSURANCE SYSTEMS: REGULATORY BARRIERS AND FUTURE DIRECTIONS · 2026 · DOI

  • The lack of clear status of marketplaces creates risks for consumer health. The lack of liability of aggregators for the quality of medicines is a problem.

    FEATURES OF REQUIREMENTS FOR THE CIRCULATION OF MEDICINES ON MARKETPLACES IN RUSSIA · 2026 · DOI

  • AND rural leaving To appreciate why e-pharmacies found such rapid acceptance in India, it is necessary to first understand the limitations of the traditional pharmacy infrastructure the country relied upon for decades. India's retail pharmacy network, though numerically large with nearly 900,000 licensed outlets, has historically suffered from multiple structural problems.

    Rise of E-Pharmacies in India: A Case Study on Growth, Operational Models, Regulatory Framework, and Future Prospects · 2026 · DOI

  • While the linkage between pharmaceutical risk control and disciplinary supervision has been established, the long-term impact of this “technological anti-corruption” mechanism on physicians’ prescribing behaviors and their underlying psychological motivations remains unexplored through systematic qualitative or longitudinal analysis.

    The role of digital pharmaceutical governance in alleviating health inequality: a case study of the “Sanya Model” for centralized regional prescription review · 2026 · DOI

  • In contrast, research centred on technological innovation or ecological challenges presents differing outcomes, underscoring that purely technical or environmental frameworks are insufficient (Sharma & Kant, 2025; Maharajh, 2025).

    The Political Economy of Substandard and Falsified Medicines: A Theoretical Framework for Supply Chain Analysis in the Greater Horn of Africa · 2026 · DOI

  • Dose-specific education modules: Since 41% of pharmacists incorrectly identified the 2.5 mg dose (instead of 10 mg) as food-independent, continuing education should focus on dosage-specific administration guidelines using case-based scenarios.

    Assessment of community pharmacists’ knowledge on rivaroxaban drug and food interactions in Sudan · 2026 · DOI

  • There is a need to understand the marketing authorization procedures in different countries. The regulatory frameworks, clinical evaluations, and post-marketing surveillance involved in the procedures are not well understood.

    MARKETING AUTHORIZATION OF PHARMACEUTICALS IN UNITED STATES (US), EUROPEAN UNION (EU) AND INDIA · 2026 · DOI

  • The lack of a clear understanding of the implications of the EU REACH restriction on synthetic polymer microparticles for the pharmaceutical industry. The need for an operational decision-making framework to interpret the restriction for pharmaceutical excipients and drug-delivery systems.

    Microplastics matter: practical implications of the EU REACH restriction for the pharmaceutical industry · 2026 · DOI

  • Balancing commercial factors such as packaging, labeling, and pricing with the need for product safety and efficacy.

    An Overview of Pharmaceutical Product Lifecycle of An Oral Solid Dosage Form · 2026 · DOI

  • There is a need for an integrated understanding of the scientific, manufacturing, regulatory, and commercial factors involved in the development and lifecycle management of oral solid dosage forms. The pharmaceutical product lifecycle of oral solid dosage forms is complex and involves multiple stages.

    An Overview of Pharmaceutical Product Lifecycle of An Oral Solid Dosage Form · 2026 · DOI

  • The study highlights the need for further research on the phenomenon of pharmaceutical colonialism and its impact on medicines sovereignty.

    Global pharmaceutical sector and ‘medicines security’ of nations in the ground of the sovereignty, security and postcolonial theories – economic and public policy perspective · 2026 · DOI

  • There is a lack of comprehensive information from pharmaceutical companies and TITCK. There is a need for regular preparation of drug recall reports.

    Analysis of Turkish Medicines and Medical Devices Agency Drug Recall Reports Between 2018-2024 · 2026 · DOI

  • Traditional quality oversight has primarily concentrated on the manufacturing phase. There is a disconnection between development, technology transfer, and postapproval stages. This disconnection has frequently led to compliance issues, data gaps, and heightened regulatory scrutiny.

    A QUALITY ASSURANCE FRAMEWORK FOR END-TO-END COMPLIANCE IN THE PHARMACEUTICAL PRODUCT LIFECYCLE: A REVIEW · 2026 · DOI

  • Future studies may address these limitations by: Employing fuzzy-DEMATEL to elucidate causal links among indicators.

    Evaluating digital twin adoption for sustainable supply chains in pharma: a fuzzy MEREC–TOPSIS approach · 2026 · DOI

  • The quality of omeprazole products is a concern in the ASEAN region. There is a need to monitor the quality of medicines sold in pharmacies.

    Quality Control Analysis of Omeprazole Capsules 20 mg in Pharmacies, Vientiane Capital, Lao PDR · 2026 · DOI

  • Future research should focus on addressing the practical challenges in implementing QRM. Future research should also explore the application of QRM in other industries.

    QUALITY RISK MANAGEMENT IN PHARMACEUTICAL INDUSTRY · 2026 · DOI

  • Addressing regulatory heterogeneity and limited capacity. Developing robust frameworks for real-world evidence. Establishing regional centers of excellence or secondment programs between regulatory agencies, academia, and industry.

    Advances in Regulatory Review Pathways in the Middle East: A Narrative Review of Reliance, Expedited Approvals, and Digitalization in Medicine Registration · 2026 · DOI

  • Emerging technologies, such as Artificial Intelligence (AI), Blockchain, and real-time analytics, can be used to improve the efficiency of the drug registration process. The integration of real-time tracking and analytics tools can enhance the DMS.

    Web-based Dossier Management System (DMS) and Emerging Technologies to Facilitate Faster Registration and Access to Human Drugs: NAFDAC’s Experience · 2026 · DOI

  • The future of Next-Gen Quality Assurance is poised for a remarkable transformation. Key areas for research and practice include continuous learning QA agents and explaining AI-driven testing decisions.

    A QUALITY ASSURANCE FRAMEWORK FOR END-TO-END COMPLIANCE IN THE PHARMACEUTICAL PRODUCT LIFECYCLE: A REVIEW · 2026 · DOI

Most-cited papers in Pharmaceutical Quality and Counterfeiting

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Open questions raised by papers listed on this page include: (1) The quality of commercially available amlodipine tablet brands in Nigeria is unknown (“QUALITY CONTROL ASSESSMENT OF THE COMMERCIALLY AVAILABLE AMLODIPINE TABLET…”, 2026); (2) The lack of real-time verification, fragmented inventory management, delayed shortage identification, and poor transparency in medicine distribution (“Pharma Watch AI: Counterfeit Medicine Detection and Shortage Prediction System”, 2026); (3) The lack of standardized metadata and data integration creates challenges for AI-enabled QA systems (“STANDARDIZATION AND DATA INTEGRATION CHALLENGES IN AI-ENABLED PHARMACEUTICAL…”, 2026); (4) The lack of clear status of marketplaces creates risks for consumer health (“FEATURES OF REQUIREMENTS FOR THE CIRCULATION OF MEDICINES ON MARKETPLACES IN…”, 2026); (5) There is a need to understand the marketing authorization procedures in different countries (“MARKETING AUTHORIZATION OF PHARMACEUTICALS IN UNITED STATES (US), EUROPEAN…”, 2026). 88 gap statements have been mined from Pharmaceutical Quality and Counterfeiting papers in our 4.5M-paper local library, which holds 464 papers on the topic; the gaps come from whichever of those papers state one. They are mostly the research gaps the authors state and the papers' abstracts, plus future-work, limitations and challenges passages. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one, so you can read the original claim in context.

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