The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore
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Notice bibliographique
Résumé
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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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle