Parallel to the FDA's Critical Path Initiative is the European Agency for the Evaluation of Medicinal Products' (EMEA) initiative – the Innovative Medicines Initiative (IMI or InnoMed) –, which aims to foster public private collaborations to accelerate drug development.
(PL) Mr President, essentially, the draft we are debating concerns the introduction of a centralised procedure whereby the European Agency for the Evaluation of Medicinal Products could issue authorisation for the marketing of advanced therapy medicinal products.
In addition, the European Medicines Agency (EMA) in its reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products [9] states that it will evaluate the strength of evidence of validation including cultural adaptation/translation as applicable to the study.
It should be noted that in spite of the ICH E11's explicit requirement for appropriate evaluation of medicinal products for children, today about 70% of the medicines given to the paediatric population and 93% of the medicines given to critically ill neonates remain unlicensed or used off-label [ 14– 16].
The developed approach has been successfully applied for the antioxidant activity evaluation of medicinal herbs tinctures, infusions and decoctions.
Fortunately, the scientific evaluation of medicinal plants was pursued in parallel.
The quantitative variation observed in the accumulation of these bioactive markers focuses on the importance of standardization and quality evaluation of medicinal formulations based on P. kurroa.
Many guidelines have been proposed by qualified authorities – those of the European Agency for the Evaluation of Medicinal Products (EMEA) being the latest published.
In Europe, the European Agency for the evaluation of medicinal products (EMEA) is the relevant authority regulating the licensure of genetically engineered vaccines.
A survey of Cameroonian medicinal plants for the evaluation of antimicrobial activity revealed that Scleria striatinux De Wild (syn. S. striatonux, S. woodii) possessed a very pronounced inhibitory activity [16].
