Among the core recommendations of the regulatory science report is increased investment in PRIME, shortening the time between scientific advice, clinical trials, and marketing authorization, and collaboration with stakeholders to ensure efficient post-approval oversight of medicines. The main features of ...
人体用药的亚硝胺杂质的要求的补充意见(EMA).pdf,EMA/425645/2020 22 February 2021 European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities
restrictionofamarketingorextensionauthorisationorapplication(insideoroutsideEEA)11A.4Regulatoryadviceonthedevelopmentoftheproduct11PartB-Overalldevelopmentofthemedicinalproductincludinginformationonthetargetdiseases/conditions13B.1.Discussiononsimilaritiesanddifferencesandpharmacologicalrationale13B.1.1Similaritiesanddifferencesof...