{"id":49841,"date":"2022-04-02T10:06:21","date_gmt":"2022-04-02T09:06:21","guid":{"rendered":"https:\/\/jazairhope.org\/?p=49841"},"modified":"2022-04-02T10:06:21","modified_gmt":"2022-04-02T09:06:21","slug":"medicaments-generiques-les-etudes-de-bioequivalence-une-alternative-pour-garantir-des-medicaments-de-qualite","status":"publish","type":"post","link":"https:\/\/jazairhope.org\/fr\/medicaments-generiques-les-etudes-de-bioequivalence-une-alternative-pour-garantir-des-medicaments-de-qualite\/","title":{"rendered":"M\u00c9DICAMENTS G\u00c9N\u00c9RIQUES : LES \u00c9TUDES DE BIO\u00c9QUIVALENCE, UNE ALTERNATIVE POUR GARANTIR DES M\u00c9DICAMENTS DE QUALIT\u00c9"},"content":{"rendered":"

ALGER – Le ministre de l’Industrie pharmaceutique, Abderrahmane Lotfi Djamel Benbahmed, a mis en avant, jeudi \u00e0 Alger, l’importance des \u00e9tudes et essais de bio\u00e9quivalence sur les m\u00e9dicaments g\u00e9n\u00e9riques pour assurer de m\u00e9dicaments locaux efficaces, \u00e9quivalents aux m\u00e9dicaments r\u00e9f\u00e9rentiels internationaux, mais \u00e0 moindre co\u00fbt, en sus de contribuer \u00e0 la promotion de l’exportation.<\/strong><\/p>\n

Intervenant \u00e0 l’ouverture d’une journ\u00e9e d’\u00e9tudes organis\u00e9e \u00e0 la facult\u00e9 de pharmacie sous le th\u00e8me “Essais de bio\u00e9quivalence: enjeux et d\u00e9fis strat\u00e9giques”, M. Benbahmed a relev\u00e9 “l’importance des \u00e9tudes de bio\u00e9quivalence dans le syst\u00e8me de qualit\u00e9 des m\u00e9dicaments g\u00e9n\u00e9riques”, arguant que ces \u00e9tudes permettent d’\u00e9valuer l’efficacit\u00e9 et la qualit\u00e9 des m\u00e9dicaments et partant de renforcer les innovations th\u00e9rapeutiques et d’analyser les aspects strat\u00e9giques, les d\u00e9fis et enjeux de ce type d’\u00e9tudes en Alg\u00e9rie.<\/p>\n

\u00c0 cet effet, le ministre a soulign\u00e9 le r\u00f4le des m\u00e9dicaments g\u00e9n\u00e9riques favorisant l’orientation des investisseurs vers la production locale des produits \u00e0 forte valeur ajout\u00e9e, repr\u00e9sentant ainsi une alternative directe \u00e0 l’importation et un outil \u00e9l\u00e9mentaire de nature \u00e0 faciliter l’acc\u00e8s aux m\u00e9dicaments.<\/em><\/strong><\/p><\/blockquote>\n

Le ministre a rappel\u00e9, dans ce sens, les projets lanc\u00e9s par le groupe public “Sa\u00efdal”, notamment la r\u00e9alisation d’un nouveau Centre de bio\u00e9quivalence \u00e0 Hussein Dey (Alger) dot\u00e9 de moyens technologiques modernes et b\u00e9n\u00e9ficiant d’une assistance technique sp\u00e9cialis\u00e9e et durable de la part du minist\u00e8re et de l’Agence nationale des produits pharmaceutiques (ANPP).<\/p>\n

Il a ajout\u00e9 qu’il sera proc\u00e9d\u00e9 au parach\u00e8vement des proc\u00e9dures de cr\u00e9ation d’un syst\u00e8me de qualit\u00e9, en pr\u00e9vision du lancement du premier champ exp\u00e9rimental dans le cadre du dossier agr\u00e9ment susceptible de favoriser l’\u00e9laboration d’\u00e9tudes de bio\u00e9quivalence des m\u00e9dicaments de Sa\u00efdal, des producteurs locaux et des multinationales pr\u00e9sentes en Alg\u00e9rie.<\/p>\n

Le ministre a \u00e9voqu\u00e9 le projet de r\u00e9alisation d’un Centre de recherches et de d\u00e9veloppement des m\u00e9dicaments g\u00e9n\u00e9riques, de la biotechnologie et la culture cellulaire au p\u00f4le pharmaceutique de la nouvelle ville de Sidi Abdallah.<\/p>\n

M. Benbahmed a mis en avant l’aspect r\u00e9glementaire relatif \u00e0 r\u00e9alisation d’\u00e9tudes de bio\u00e9quivalence dans le cadre du d\u00e9cret ex\u00e9cutif 20-272 du 29 septembre 2020 portant organisation de l’administration centrale du minist\u00e8re de l’Industrie pharmaceutique en vertu duquel le secteur a \u00e9t\u00e9 charg\u00e9 de l’examen des dossiers de demande de r\u00e9alisation d’\u00e9tudes de la bio\u00e9quivalence et de l’\u00e9laboration des autorisations y aff\u00e9rent ainsi que le suivi de leur mise en \u0153uvre.<\/p>\n

Selon le ministre, le concept de la bio\u00e9quivalence a \u00e9t\u00e9 introduit dans les textes d’application relatifs aux modalit\u00e9s d’enregistrement des produits pharmaceutiques, stipulant l’obligation de pr\u00e9senter l’\u00e9tude de la bio\u00e9quivalence et de tous les essais sur la bio\u00e9quivalence th\u00e9rapeutique pour certains m\u00e9dicaments g\u00e9n\u00e9riques et bio-th\u00e9rapeutiques similaires.<\/p>\n

\u00c0 ce propos, le ministre a appel\u00e9 les acteurs du secteur \u00e0 consentir davantage d’efforts pour augmenter la production et la rentabilit\u00e9 en la mati\u00e8re tout en \u0153uvrant \u00e0 aplanir les difficult\u00e9s et \u00e0 faire face \u00e0 la concurrence mondiale.<\/p>\n

Selon les explications pr\u00e9sent\u00e9es lors de cette journ\u00e9e d’\u00e9tude, la bio\u00e9quivalence et l’\u00e9quivalence pharmaceutique constituent, en termes de composition qualitative et quantitative du principe actif, une “preuve” quant \u00e0 l’\u00e9quivalence des produits g\u00e9n\u00e9riques avec leurs produits de r\u00e9f\u00e9rence, ce qui garantit au patient alg\u00e9rien des m\u00e9dicaments locaux efficaces et s\u00fbrs \u00e0 l’image des produits de r\u00e9f\u00e9rence\u00a0 internationaux”.<\/p>\n

Le minist\u00e8re de l’Industrie pharmaceutique a accord\u00e9 une importance majeure \u00e0 ces \u00e9tudes \u00e0 travers la mise en place des r\u00e8glements devant assurer la conformit\u00e9 des investissements des producteurs locaux de m\u00e9dicaments (non exempt\u00e9s) en vue d’\u00e9largir le champ de production notamment vers les produits de grande valeur ajout\u00e9e.<\/p>\n

Source\u00a0: APS<\/em><\/p>\n

FC-DZ<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

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