Actualités Réglementaires

Cette rubrique a pour objectif de vous informer de la publication de documents cadre et lignes directrices approuvées ou soumises à consultation, dans les domaines de la toxicologie.

N'hésitez pas à nous faire part des nouveaux textes que vous jugeriez utile de mentionner dans cette rubrique.

 

- DRAFT guideline on the use of phtalates as excipients in human medicinal products (EMA/CHMP/SWP/362974/2012 du 25 avril 2013)

- DRAFT reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use (EMA/CHMP/SWP/272921/2012 du 25 avril 2013)

- Final Concept paper on extrapolation of efficacy and safety in medicine development (EMA/129698/2012 du 19 Mars 2013)

- ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK M7 - Current Step 2 version - dated 6 February 2013

- Concept Paper S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals Dated and endorsed by the Steering Committee on 14 November 2012

- DRAFT CONSENSUS GUIDELINE PHOTOSAFETY EVALUATION OF PHARMACEUTICALS S10 - Current Step 2 version - dated 15 November 2012

Nouveau(x) texte(s) d'intérêt dans le domaine de la toxicologie alimentaire

- EFSA - Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment

 

Nouveau(x) texte(s) d'intérêt dans le domaine de la toxicologie des cosmétiques

- 8th revision of SCCS's note for guidance for the testing of cosmetic ingredients and their safety evaluation