Stuart Walker's research while affiliated with University of Hertfordshire and other places

Publications (93)

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Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspec...
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Background: The Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the consolidated registration of pharmaceutical products throughout the member states of the Gulf Cooperation Council. Objectives: The objectives of this study were to provide an update of the performance of the GCC-DR cen...
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Introduction ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall median time to recommendation of 12 months. All 16 SADC countries participate in the initiative as either active or non-active member...
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Introduction The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate and conduct joint reviews of applications. One such collaborative medicines registration initiative is the Southern African D...
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Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems of comparable size provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients' access to medicines. The aim of this study was to compare the medicines registration process of the M...
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Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern Afric...
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Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development C...
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Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulatory review processes and the good review practices...
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Purpose The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate the overall performance from 2017 to 2019, identify good review practices, evaluate the quality of decision-making processes, and identify the challenges an...
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Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. This study aimed to develop a new...
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Background: The development of a medicine is not only underpinned by good science but also by Quality DecisionMaking Practices (QDMPs). Indeed, it is important to ensure that all organisations involved in the lifecycle of medicines are aligning their practices in decision-making to the QDMPs to ensure quality, transparent and consistent decisionma...
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Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as a tool to communicate the basis for the decision. The Universal Methodology for Benefit-Risk Assessment (UMBRA) has also been used to effectively communic...
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Background Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into a learning system. Nevertheless, such a correlation can only be achieved by documenting the expected outcome of a decision at the time it is made, e...
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The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa initiative, reflects on what has been realized in six years of operation and what still needs to be achieved. Statistics...
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Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations for the implementation of an abridged review process in South Africa based on good reliance practices (GRelP).MethodsA questionnaire was...
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Introduction The aim of this study was to explore patients’ knowledge and perspectives in Istanbul, Turkey about the pharmaceutical regulatory review and reimbursement processes with respect to patients’ access to new medicines. Methods For the purpose of this study a tailored made paper-based questionnaire, Patient Perspective Questionnaire (PPQ)...
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Background This study was to evaluate the Turkish regulatory review process and timelines between 2016 and 2018 with a view to assess the changes that had taken place since the previous study, which evaluated the Turkish review processes and timelines 2013 to 2015.Methods Data related to the Turkish Medicines and Medical Devices Agency (TİTCK) orga...
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Background:To evaluate the quality of the decision-making processes of pharmaceutical companies during medicines development for evidence generation to support reimbursement of new medicines and the appraisal recommendation decision-making process by health technology assessment (HTA) agencies.Methods:Two questionnaires were developed and subsequen...
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Background Timely access to new medicines may be addressed through strengthening of registration efficiencies and timelines by establishing and refining value-added registration processes, resources, and systems. The aims of this study were to evaluate the timelines of the milestones of the South African review process and the overall approval proc...
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Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move toward achieving their regulatory goals and stakeholders’ demands. The aims of this study we...
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Background:: To evaluate the quality of the decision-making processes of pharmaceutical companies during medicines development for evidence generation to support reimbursement of new medicines and the appraisal recommendation decision-making process by health technology assessment (HTA) agencies. Methods:: Two questionnaires were developed and s...
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Introduction: The Quality of Decision-Making Orientation Scheme (QoDoS) was developed to provide organisations involved in submission, approval and reimbursement of new medicines with a tool to improve the quality of their decision-making processes and is considered the most promising tool for such purpose. This study aimed to further establish the...
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The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date...
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Background: The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practi...
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Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK...
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Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, b...
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Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those or...
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Background: In 2008, a consortium of 4 regulatory authorities, the Australian Therapeutic Goods Administration (TGA), Health Canada, Swissmedic, and Singapore Health Sciences Authority (HSA) approached the Centre for Innovation in Regulatory Science (CIRS) to support the development of a benefit-risk framework and template that could be used by al...
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Objective This study outlines the current regulatory review process and good review practices (GRevPs) at the Jordan Food and Drug Administration (JFDA) and compares them with those of regulatory agencies in Australia, Canada, Saudi Arabia and Singapore to gauge how well the JFDA is performing. We identify opportunities for further development of t...
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Objectives: To evaluate the national regulatory, health technology assessment (HTA), and reimbursement pathways for public health care in Australia, Canada, England, and Scotland, to compare initial Canadian national HTA recommendations with the initial decisions of the other HTA agencies, and to identify factors for differing national HTA recomme...
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Background: The CADTH Common Drug Review was established in 2002 to prepare national health technology assessment reports to guide listing decisions for 18 participating drug plans. The aim of this study was to compare the nonmandatory recommendations from the Common Drug Review in Canada with the listing decisions of provincial payers to determin...
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Background: Although the quality of decision making (QDM) in the development and regulatory review of medicines influences the delivery of new products, there appears to be no suitable instrument to assess QDM in this area. The aim of this study was to assess differences in QDM using a validated instrument, the Quality of Decision-Making Orientati...
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Introduction: The impact of decision-making during the development and the regulatory review of medicines greatly influences the delivery of new medicinal products. Currently, there is no generic instrument that can be used to assess the quality of decision-making. This study describes the development of the Quality of Decision-Making Orientation S...
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Background: The science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is research into decision making in medicines research and development. The aims of this study were to determine the current decision-making practices and methodologies for measuring the quality of the d...
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Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence. Methods: A questionnaire completed by the SFDA in...
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Structured frameworks for benefit-risk analysis in drug licensing decisions are being implemented across a number of regulatory agencies worldwide. The aim of these frameworks is to aid the analysis and communication of the benefit-risk assessment throughout the development, evaluation, and supervision of medicines. In this review, authors from reg...
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The aim of this study was to examine the views and experiences of the Gulf Cooperation Council (GCC) states and pharmaceutical companies to identify the strengths and weaknesses of the GCC centralized registration procedure (GCC-CP). Results of a questionnaire designed for the study and completed by GCC regulatory authorities and pharmaceutical com...
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The importance of a framework for a systematic structured assessment of the benefits and risks has been established, but in addition, it is necessary that the benefit-risk decisions and the processes to derive those decisions are documented and communicated to various stakeholders for accountability. Hence there is now a need to find appropriate to...
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Objective This study sought to assess the current regulatory review process in Saudi Arabia, identify the key milestones, evaluate the measures used for Good Review Practices (GRevP) and to suggest opportunities for an enhanced regulatory review of medicines. Methods A questionnaire completed by the Saudi Food and Drug Authority (SFDA) was divided...
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PurposeCurrently, there is no qualified understanding of the influences, behaviours and other factors that impact the decision-making of individuals and organisations involved in the development of new medicines. The aim of this qualitative study was to investigate and identify the important issues that influence quality decision-making.Methods Sem...
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The current climate in regulatory science seeks transparency of decision-making and communication to stakeholders for accountability. The results from Chap. 3 showed that both regulatory agencies and pharmaceutical companies believe that a benefit–risk framework would enhance the quality (transparency and consistency) of decision-making; provide do...
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Currently, there is a need to understand why different regulatory agencies come to different outcomes despite having the same data submitted for their assessment. This has led to an increasing pressure on agencies to improve transparency and accountability and establish appropriate document governance for their decision-making processes. A universa...
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Drug regulatory authorities are constantly challenged to develop and improve their capacity to regulate pharmaceutical products. Therefore, it is critical to develop regulations based on two broad objectives, namely, to provide technical assistance in establishing and implementing effective strategies for monitoring quality and correcting deficienc...
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The historical implementation of the central registration system was subject to several criticisms with challenges from both the pharmaceutical industry and government. The GCC-DR received 1,824 medicinal product applications out of which 1,165 (64 %) applications were approved during the 11 years from 1999 to 2010. The pharmaceutical industry was...
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The benefit–risk assessment of medicines is a critical process in regulatory decisions, resulting in their approval or rejection. Regulatory authorities bear the responsibility to ensure that the approved products demonstrate the efficacy and safety as shown in the clinical trial data submitted. However, such regulatory decisions are largely based...
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The regulation of medicines has evolved over the last five decades in response to serious adverse events in relation to medicinal products. The early regulatory standards, which mainly relate to ensuring the quality of pharmaceutical products and subsequent advances in the early 1960s, led to the development of new standards for assessing the safet...
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Long regulatory approval timelines for new medicines delay their access to the market that may have the potential to improve patients’ health status and of alleviating suffering. Variation in the availability of medicines in different countries has been studied since the early 1970s (Rawson 2000), and some marked differences have been identified. R...
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Although an awareness of the important role of drug safety monitoring (pharmacovigilance) in the Gulf states has dramatically improved in recent years, communication of medicines benefits and harms between the various stakeholders, such as regulatory authorities, pharmaceutical industry, healthcare professionals and consumers, lags far behind. Duse...
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Modern-day licensing began in the 1940s with the formation and constitution of the World Health Organization (WHO) and its recommendation that global standards be established in relation to the safety, quality and efficacy of biological, pharmaceutical and similar products and extending this to their labelling and advertising (Crout 1998). However,...
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The evaluation of medicines has traditionally been conducted as separate assessments of efficacy and safety, in which a regulatory decision is based on proven efficacy supported by clinical studies matched with an acceptable safety profile. The trend in the assessment of benefits and risks is currently towards a holistic discussion of the benefits,...
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The approval of medicines in different countries across the world has been and still is performed by regulatory agencies according to their national regulations, although attempts to harmonise the regulations have been made for several years within the GCC region. The harmonisation of the regulatory review processes in the GCC states was initiated...
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With the evolution of the assessment of efficacy and safety towards systematic explicit benefit–risk balance, both regulatory agencies and pharmaceutical companies have developed frameworks albeit each for their own jurisdiction and purpose. Given the individual efforts, this will perpetuate the problem of inconsistency in regulatory decision-makin...
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The primary aim of drug regulation is the protection of public health. However, Hill and Johnson (2004) suggested that for some the balance between regulating pharmaceuticals in the interests of ensuring public health and encouraging the development of pharmaceutical products has shifted in favour of the innovative industry. Furthermore, regulation...
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The assessment of benefits and risks of medicinal products for regulatory approval remains largely a qualitative exercise, although there are ongoing initiatives to introduce a quantitative approach into the review process. Given the current setting, it is important that both the processes and the benefit–risk decisions are transparent and communic...
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The availability of new medicines is influenced by different stakeholder perspectives including those of the regulators, policymakers and the pharmaceutical industry. These differences are reflected in the historical high-profile drug withdrawals and the rising demand for improving medicines development to protect patients from the predictable harm...
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The evolution in the requirements for assessing the benefits and risks of medicinal products has resulted in changes in the evaluation processes. Beyond the separate assessment of benefits and risks, the emphasis is now on the balance between the two, having to justify the potential harms in view of the efficacy claims. In a changing society where...
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The most significant regulatory initiative that the GCC member states have proactively implemented as part of their goal to standardise their regulatory systems is the Common Technical Document (CTD). The CTD format was adopted in all member states in January 2012 as part of the central registration procedure. This initiative reflected the assessme...
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The Centralised Procedure is designed to improve the operation of the ‘single market’ for medicinal products, the avoidance of duplication of scientific evaluation and the reduction of the administrative burden. Apart from these, product safety enhancement and harmonisation are also important for this region. However, the situation in the Gulf cent...
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The Gulf Cooperation Council (GCC) was established on May 25, 1981, with the six Arab states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE). The GCC’s primary role is to formulate standardised regulations in various fields such as economics, finance, trade, customs, tourism, health, legislation and administration, establish scientific researc...
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The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium o...
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The aim of the study was to evaluate the Gulf Cooperation Council (GCC) centralized regulatory review process. Regulatory review times—including submission and application dates for new active substances (NASs) and existing active substances (EASs) using a standardized template for the period of 2006 to 2010—were collected directly from the GCC off...
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Assessing the utility of structured approaches to benefit-risk assessment of medicinal products is challenging, in part due to the lack of a gold standard for results and the uncertainty inherent in the data. In place of conducting formal testing, obtaining feedback from users of structured approaches provides insight into their value and limitatio...
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A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, as it would result in the systematic structured approach to support transparency in decision making. Several organizations have developed f...