Characterizing Good Review Practices: A Survey Report Among Agencies of APEC Member Economies

Liu, Li Ling; McAuslane, Neil; Tzou, Meir Chyun; Chern, Herng-Der; Liberti, Lawrence; Ward, Monika A.; Kang, Jaw Jou

doi:10.1177/2168479013494394

Cited by 8 publications

(12 citation statements)

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“…The Centre for Innovation in Regulatory Science (CIRS) developed a three-part standardised questionnaire that was completed by JFDA personnel to determine agency regulatory review processes and practices. This instrument was originally developed to gather information about regulatory systems in jurisdictions with emerging pharmaceutical markets [ 10 ] and subsequently for a study of GRevPs in the Asia–Pacific Economic Cooperation (APEC) region [ 11 ] and in Saudi Arabia [ 3 , 12 ].…”

Section: Methodsmentioning

confidence: 99%

The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore

et al. 2016

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ObjectiveThis 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 the JFDA as a key global reference agency.MethodsPersonnel within the JFDA completed a questionnaire comprising four sections: organisation, key milestones, review timelines, and GRevPs. The same questionnaire was used concurrently to gather information from Australia’s Therapeutic Goods Administration (TGA), Health Canada, the Saudi Food and Drug Authority (SFDA) and Singapore’s Health Sciences Authority (HSA).ResultsThe JFDA conducts an abridged review for new active substances and requires a certificate of pharmaceutical product (CPP) at the time of submission and 6 months of pharmacovigilance data at the time of the final review as well as full pharmaceutical, chemistry, manufacturing and controls (CMC) and clinical data at the time of submission. A written summary and tabulated data are required for non-clinical data. The four comparator agencies conduct full assessments; the SFDA also requires a CPP, and the JFDA and SFDA both require pricing information at submission. All agencies have established target timelines, and the JFDA, SFDA, TGA and HSA currently exceed those targets. All agencies have also developed GRevPs as well as training and continuous-improvement processes.ConclusionsThe JFDA has achieved significant success in its role as a regulatory agency by setting and implementing clear regulations in line with international guidance. It is recognised as a training centre in the region, with considerable achievements in the development of its activities by simplifying and improving requirements, procedures and actions. It also publishes information regarding guidance, procedures, drug application submissions and registration dates for all new chemical entities on its website. The relationship between the JFDA and the pharmaceutical sector in Jordan has resulted in balanced, practical, internationally compatible regulations and demonstrates a viable model of collaboration. To assist the JFDA in its efforts to become a key global reference agency, it is suggested that the agency explore a risk-stratification approach to the regulatory review; accept CPPs after dossier submission or use alternatives to the CPP; conduct pricing evaluations in parallel with scientific assessments; establish defined target times for review milestones and improve internal tracking systems to monitor these milestones; and make certain information transparent to all stakeholders by publishing a summary basis of approval.

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Section: Methodsmentioning

confidence: 99%

The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore

et al. 2016

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“…Regulatory clarity is one of the key elements in GRevP. 11 Rapid advances in innovative science have contributed to brand-new medicinal product development with distinct characteristics, and TFDA must keep pace with and construct appropriate guidelines. In the past few years, TFDA has published a lot of guidance for special categories of new drugs, including botanical, biosimilar monoclonal antibodies, and cell therapy medicinal products.…”

Section: Innovative Regulatory Strategies For New Drug Approvalmentioning

confidence: 99%

Regulation of New Drug Approval in Taiwan

Yang

Huang

Chen

et al. 2016

Ther Innov Regul Sci

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Taiwan Food and Drug Administration (TFDA) was established in 2010 as the nation's principal consumer product protection agency of food, drugs, medical devices, and cosmetics. By integrating 4 agencies (the Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis, and Bureau of Controlled Drugs), TFDA holds the mission of protecting and promoting the public health through regulation modernization to enhance the availability of safe medical products and foods. To address the unmet medical needs and public health, TFDA has utilized regulatory science to evaluate review principles and risk management to properly oversee the overall life cycle of medicinal products. A lot of measures have been accomplished to build an efficient, transparent, and internationally harmonized regulatory system. With the first-in-the-world new drug afatinib approved in Taiwan, TFDA has successfully built up capacity and capability in the review and approval of new drugs. This article summarizes the efforts TFDA has been making in the domain of medicinal product management, highlighting policies and strategies for the future.

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“…In a survey among agencies of APEC member economies, GRevP was defined as a code about the process and the documentation of review procedures that aims to standardize and improve the overall documentation and ensure timeliness, predictability, consistency, and high quality of reviews and review reporst. 2…”

Section: The 2011 Apec Good Review Practice Workhop On Medical Productsmentioning

confidence: 99%

“…However, obstacles such as differences in depth of review, language barriers, and lack of confidentiality agreements must be overcome. 2…”

Section: The 2011 Apec Good Review Practice Workhop On Medical Productsmentioning

confidence: 99%

“…Currently, there is a lack of uniformity in review practices for medical products among Asia-Pacific Economic Cooperation (APEC) economies, as each economy has different regulatory practices, levels of expertise, and capacity. 2,3 However, for transparency and efficiency, implementation of GRevP in each economy can be valuable. Appropriate and effective management of the review process based on scientific considerations would bring safe and effective medical products to the market in a more efficient way.…”

Section: Introductionmentioning

confidence: 99%

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APEC Workshop Report of Good Review Practices on Medical Products

Lin

Chen

Gau

et al. 2015

Ther Innov Regul Sci

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As part of the implementation of the 2020 Good Review Practices (GRevP) Roadmap championed by Chinese Taipei in the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC), the Taiwan Food and Drug Administration (TFDA) organized 2 workshops. The purpose of these workshops was to address the fundamental elements of a well-designed regulatory review system, to provide complementary modules for GRevP and approaches to the exchange and the use of product assessment reports between regulatory authorities, and to further promote regulatory efficiencies and best practices. The workshops brought together 81 regulatory representatives from 15 economies for the basic workshop and 133 from 20 economies for the advanced workshop. Participants forged a common understanding of GRevP and highlighted its importance. While the adoption of GRevP is key to building trust between agencies, each economy should address its needs and adopt its own best practices based on its resources and environment. The outcomes of these workshops could be used as a framework for the development of a GRevP best-practice document or could serve as material for further training in each economy.

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Characterizing Good Review Practices: A Survey Report Among Agencies of APEC Member Economies

Cited by 8 publications

References 1 publication

The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore

The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore

Regulation of New Drug Approval in Taiwan

APEC Workshop Report of Good Review Practices on Medical Products

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