| アブストラクト | 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 the JFDA as a key global reference agency. METHODS: Personnel 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). RESULTS: The 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. CONCLUSIONS: The 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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| ジャーナル名 | Pharmaceutical medicine |
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| Pubmed追加日 | 2017/6/3 |
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| 投稿者 | Haqaish, Wesal Salem Al; Obeidat, Hayel; Patel, Prisha; Walker, Stuart |
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| 組織名 | Drug Registration, Jordan Food and Drug Administration, Shafa Badran, Amman,;Jordan 11181 Jordan.;Global Development Programme, Centre for Innovation in Regulatory Science, 77;Hatton Garden, London, EC1N 8JS UK.grid.475064.40000000406123781;Pharmaceutical Medicine, School of Pharmacy and Pharmaceutical Sciences, Cardiff;University, Cardiff, Wales.grid.5600.30000000108075670 |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/28572733/ |
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