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Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019
BackgroundQuality by Design (QbD) is a systematic risk-based approach to development, with predefined characteristics and quality risk management...
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Safety profile of herbal medicines submitted for marketing authorization in Tanzania: a cross-sectional retrospective study
BackgroundThe popular use of herbal medicines necessitates national regulatory authorities to have efficient mechanisms for the control of these...
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Marketing authorization of COVID-19 vaccines across UK, EU, and the US: fact-checking and the implications for future research
While having access to safe and efficient vaccines is essential for eradicating the COVID-19 pandemic, gaining marketing authorisation is a critical...
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Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)
BackgroundThe aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic...
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Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA
PurposeThis research study aims to determine the qualitative and quantitative common deficiencies included in the API section of dossiers submitted...
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Regulatory requirements for the registration of generic medicines and format of drug dossiers: procedures in Sri Lanka in comparison with selected regulatory authorities
BackgroundThe regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities....
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Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022
BackgroundVarious regulatory authorities are experiencing backlogs of applications which result in delayed access to medicines for patients. The...
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Pediatric Market Access: A Qualitative Study
ObjectivesThis qualitative study aims to analyze current PM regulation and market access requirements and proposes potential solutions to mitigate...
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Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries
Regulators and pharmaceutical companies across the world are intensifying efforts to get increasingly complex and innovative drugs to patients with...
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Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future—An Industry View
The COVID-19 pandemic caused considerable disruption to the development, regulatory evaluation, production, and distribution of medicinal products....
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Increased Patient’s Risk Associated with the Canadian Bioequivalence Guidance Due to Outlier Removal
BackgroundThe Canadian guideline on bioequivalence allows identification of outliers through for example studentized residuals, and it explicitly...
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Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA)
BackgroundThe cost of healthcare has become expensive globally, of which the greater part of the money is spent on buying innovator medicines. In...
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Pharmaceutical Quality System
Quality Management, as defined in the EU GMP guide, is a wide-ranging concept, which covers all matters that individually or collectively influence...
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Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities
PurposeThis study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones,...
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Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study
BackgroundCognizant of indispensable role as important health intervention tools, the global medical devices industry continues to bring new medical...
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Liposomal Pharmaceutical Products: Methods of Analytical Characterization and Quality Control
Modern methods of analytical characterization and quality control of liposomal pharmaceutical products are reviewed. Analytical studies are shown to...
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Equity in Access to and Quality Use of Medicines in Low- and Middle-Income Countries
Equitable access for all people to affordable, quality-assured essential medicines and other health technologies, and quality use of them, is needed...
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phactMI™ Benchmarking Survey: Analysis of 27 Medical Information Departments Responses to Inquiries from Health Care Decision Makers
BackgroundThe nature in which health care insurance companies have interacted with drug manufacturers has evolved over the last 50 years, demanding...
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Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry
BackgroundMedical-product companies often outsource research and manufacturing needs to contracting or partnering organizations but then must manage...
