PReS13-SPK-1408: New EU scientific guidelines for JIA, SLE and GIOP from the European Medicines Agency
نویسنده
چکیده
Background: Development of EU guidelines Guideline (GL) in the pharmaceutical legislative framework represents a harmonised EU approach based on the most up-to-date scientific knowledge to facilitate planning the overall pharmaceutical product development, the preparation of applications for marketing authorisations by the pharmaceutical industry and the assessment, approval and control of medicinal products in the European Union. It has no legal force ("soft law” non-legally binding but quasi-binding character). Alternative approaches may be taken, provided that these are appropriately justified.
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