Reliance: a smarter way of regulating medical products - The IPRP survey

Doerr, Petra; Valentin, Marie; Nakashima, Nobumasa; Orphanos, Nick; Santos, Gustavo Alves Andrade dos; Balkamos, Georgios; Saint‐Raymond, Agnès

doi:10.1080/17512433.2021.1865798

Cited by 8 publications

(8 citation statements)

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“…Overall, results of this study support previous recommendations made by Keyter and associates [ 20 ], including the need to continue placing reliance on trusted reference authorities that have met the requirements of standardised regulatory benchmarking tools, with verification that applications submitted to national or regional authorities are materially the same as those submitted by a reference authority. In addition, a survey among 17 NRA members of the International Pharmaceutical Regulators Programme (IPRP) showed that reliance is increasingly being used for medical product oversight, in areas such as marketing authorisations and good manufacturing practices [ 21 ], with the view that such activities enable better resource use within authorities and should facilitate earlier access to safe, effective medicines that are quality assured. Indeed, reliance in regulatory practice should encourage comprehensive exchange of information among the regulatory authorities.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities

et al. 2023

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Background Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to middle-income countries. On the African continent, this is partly due to capacity limitations of National Regulatory Authorities (NRAs). One important approach to address this issue is work sharing and regulatory reliance. Therefore, the aim of this study of regulatory authorities on the African continent was to identify which risk-based approaches are being used as well as their foreseen role in the future. Methods The study employed a questionnaire to identify which risk-based models are used for the regulatory approval of medicines and to determine which frameworks are in place to enable a risk-based approach, as well as to provide insight into the future direction for risk-based models. The questionnaire was sent electronically to 26 NRAs in the African Continent. Results Twenty-one authorities (80%) completed the questionnaire. Work sharing was the most commonly used model, followed closely by unilaterial reliance, information sharing, and collaborative review. These methods were perceived to be an effective and efficient use of resources, enabling faster medicine availability for patients. The unilateral reliance approach by the authorities included abridged (85%), verification (70%) and recognition (50%) models for a range of products. However, challenges included a lack of guidelines to undertake a reliance review together with resource constraints, while access to assessment reports was the most common barrier to using a unilateral reliance model. Conclusions Many authorities in Africa have adopted a risk-based approach to medicines registration and created work sharing, unilateral reliance pathways and regionalisation models to facilitate the availability of medicines. The authorities believe that in future, assessment routes should move from stand-alone reviews to risk-based models. However, this study indicated that there would be challenges to implement this approach in practice, which would include improving resource capacity and the number of expert reviewers as well as implementing electronic tracking systems. Supplementary Information The online version contains supplementary material available at 10.1007/s40290-023-00472-0.

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Section: Discussionmentioning

confidence: 99%

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities

et al. 2023

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“…Among other highlighted lessons from the training, an increased understanding of the concept of reliance in regulatory activities is crucial in fighting the wrong notions that matured NRAs are self-sufficient or that relying on others signifies weakness. In that respect, recent findings have shown the growing use of reliance across many regulatory agencies ( 12 , 13 ). Moreover, lessons on having functional regulatory systems encourage the shift in regulators’ focus towards the creation and strengthening of suitable systems for increased regulatory proficiency.…”

Section: Discussionmentioning

confidence: 99%

“…The reported implementation of various learnt aspects by the trainees underscores the role of regulatory training in the strengthening of regulatory systems in the LMICs. In that, the NRAs in the LMICs can potentially attain more robust and thorough regulatory processes towards better access to safe, effective, and good-quality medical products ( 12 , 13 ). Moreover, the shared success stories from the trainees signify the possibility of implementing sustainable changes in the whole regulatory landscape and in turn gaining more confidence and satisfaction from stakeholders, customers, and the public ( 14 , 18 – 20 ).…”

Section: Discussionmentioning

confidence: 99%

Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

Dehaghi,

Khadem Broojerdi,

Paganini

et al. 2023

Front. Med.

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IntroductionTraining opportunities for health product regulators are among the critical aspects in the strengthening of regulatory systems across the world. The need for training is reasonably higher among the National Regulatory Agencies (NRAs) in the Low- and Middle-Income countries (LMICs) which are faced with many regulatory challenges mostly rooted in the low availability of resources. The current study aimed at evaluating the suitability, impacts, and challenges related to the training of regulators from LMICs offered by the Swissmedic in collaboration with the World Health Organization (WHO).MethodologyAn exploratory case study design using a qualitative approach was adopted to collect data from a total of 17 NRAs in different WHO regions using in-depth interviews and qualitative questionnaires.ResultsThe participation of the trainees in the training was revealed to be motivated by the need to apply the obtained knowledge in addressing various challenges within their NRAs. Many lessons covering all key areas of health products regulation were reported by the trainees, whereby most of the lessons were already being implemented within their respective NRAs. However, challenges related to human, financial, and infrastructural resources were highlighted to hinder the ongoing efforts in putting the learned aspects into practice. Additionally, areas in which further regulatory assistance and suggestions for improving the training activities were pointed out.ConclusionThe highlighted gains from the WHO-Swissmedic collaborative training program call for other agencies and organizations to join hands in offering much-needed support towards addressing critical challenges facing the regulatory sector in the LMICs.

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“…The clustering of reliance and unknown pathway authorizations in non-reference countries may be influenced by non-reference NRAs generally being more resource restricted and less transparent in reporting the nature of the pathways used compared to reference NRAs ( 15 ), since resource limitations incentivize reliance on others ( 16 ), and a lack of transparency is associated with a limited amount of publicly available data about the applied pathway ( 15 ). All authorizations in non-reference countries of which the applied pathway was known used reliance; hence, it might be expected that some or even most of the unknown pathways used by non-reference NRAs were also reliance pathways, especially given that most Latin American countries already had reliance pathways in place ( 10 ).…”

Section: Discussionmentioning

confidence: 99%

Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America

Zee

Vreman

Liberti

et al. 2022

Revista Panamericana De Salud Pública

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Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results. 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions. This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency.

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Reliance: a smarter way of regulating medical products - The IPRP survey

Cited by 8 publications

References 0 publications

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities

Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities

Collaborative training of regulators as an approach for strengthening regulatory systems in LMICs: experiences of the WHO and Swissmedic

Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America

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