Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africa
Committee for Medicinal Products for Human Use (CHMP): 22-25 April 2024, European Medicines Agency, Amsterdam, the Netherlands, from 22 April 2024 to 25 April 2024
Minutes of the HMPC meeting 27-29 May 2024
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)
Union list of critical medicines: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) / Product Management System (PMS) entries
Proposed invented name(s) request form for human medicinal products
Orphan designation: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid Treatment of systemic sclerosis, 28/06/2024 Positive
Orphan designation: 4-[[[4-[5-Chloro-2-[[trans-4-[[(1R)-2-methoxy-1-methyl-ethyl]amino]cyclohexyl]amino]-4-pyridinyl]-2-thiazolyl]amino]methyl]tetrahydro-2H-pyran-4-carbonitrile Treatment of acute myeloid leukaemia, 28/06/2024 Positive
Orphan designation: Human IgG1 monoclonal antibody against hepatitis B virus, surface antigen Treatment of hepatitis D virus infection, 28/06/2024 Positive