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• | In Jordan, Jordan Food and Drug Administration (JFDA) is the sole reference competent authority responsible for the safety and efficacy of medicinal products as well as the safety and quality of food in Jordan. |
• | JFDA practices its critical role and achieves significant success by setting and implementing clear regulations in-line with international guidelines such as those of EMA, US-FDA, ICH, and WHO. |
• | Since 2009, JFDA has started to evaluate the submitted biosimilars’ applications based on an exercise to demonstrate similarity in terms of quality, safety and efficacy of an already approved reference product, similar to what's required by European Medicines Agency (EMA) biosimilars’ related guidelines [ 2European Medicines Agency [homepage on the internet]. Available from: https://www.ema.europa.eu/en.
Cliquez ici pour aller à la section Références, 3European Medicines Agency. Guideline on Similar Biological Medicinal Products [homepage on the internet]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf.
Cliquez ici pour aller à la section Références, 4European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substances: Quality Issues [homepage on the internet]. Available from: https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance.
Cliquez ici pour aller à la section Références, 5European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues [homepage on the internet]. Available from: https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical-clinical-issues.
Cliquez ici pour aller à la section Références]. |
• | In May 2015, JFDA biosimilars registration guidance was approved officially and published on its website. This guidance has adopted EMA biosimilar guidelines, which are considered the most well established guidelines globally in this arena. |
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In 2015, JFDA approved its biosimilars registration guidelines [1JFDA. Guideline for registration of biosimilars in Jordan [homepage on the internet]. Available from: http://www.jfda.jo/EchoBusV3.0/SystemAssets/PDF/AR/Laws AndRegulation/Drug/RegisterSection/10_303.pdf.
Cliquez ici pour aller à la section Références] officially. Many steps have been taken before achieving this progress. This paper summarizes briefly JFDA efforts that were done in the previous years and the actions taken to approve JFDA biosimilars registration guidance which was based on EMA related guidelines [2European Medicines Agency [homepage on the internet]. Available from: https://www.ema.europa.eu/en.
Cliquez ici pour aller à la section Références, 3European Medicines Agency. Guideline on Similar Biological Medicinal Products [homepage on the internet]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf.
Cliquez ici pour aller à la section Références, 4European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substances: Quality Issues [homepage on the internet]. Available from: https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance.
Cliquez ici pour aller à la section Références, 5European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues [homepage on the internet]. Available from: https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical-clinical-issues.
Cliquez ici pour aller à la section Références], and its impact on enhancing the affordability of safe, effective and high quality biosimilars for patients.
Le texte complet de cet article est disponible en PDF.
En 2015, la FDA jordanienne (JFDA) a officiellement approuvé les guidelines nationales pour l’enregistrement des médicaments biosimilaires en Jordanie [1JFDA. Guideline for registration of biosimilars in Jordan [homepage on the internet]. Available from: http://www.jfda.jo/EchoBusV3.0/SystemAssets/PDF/AR/Laws AndRegulation/Drug/RegisterSection/10_303.pdf.
Cliquez ici pour aller à la section Références]. Ce progrès aura nécessité de franchir de nombreuses étapes. Cet article résume brièvement les efforts déployés par la JFDA durant les années qui l’ont précédé; les mesures prises pour approuver ses guidelines, inspirées des guidelines de l’Agence européenne du médicament (EMA) [2European Medicines Agency [homepage on the internet]. Available from: https://www.ema.europa.eu/en.
Cliquez ici pour aller à la section Références, 3European Medicines Agency. Guideline on Similar Biological Medicinal Products [homepage on the internet]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf.
Cliquez ici pour aller à la section Références, 4European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substances: Quality Issues [homepage on the internet]. Available from: https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance.
Cliquez ici pour aller à la section Références, 5European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues [homepage on the internet]. Available from: https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical-clinical-issues.
Cliquez ici pour aller à la section Références], ainsi que leur impact sur l’amélioration de l’accessibilité de biosimilaires sûrs, efficaces et de haute qualité pour les patients en Jordanie.
Le texte complet de cet article est disponible en PDF.
Keywords : Biosimilars, Reference biological product/reference product (RBP), EMA, US-FDA, ICH, WHO
Mots clés : Biosimilaires, Jordanie, Directives d’enregistrement, Produit de référence, EMA, US-FDA, ICH, OMS
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Académie Nationale de Pharmacie. Publié par Elsevier Masson SAS. Tous droits réservés.