Committee for Medicinal Products for Human Use (CHMP)
The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. It plays a vital role in the authorisation of medicines in the European Union. The committee meets once a month. EMA publishes agendas, minutes and highlights of its plenary meetings.
The evaluation of medicines, step-by-step - European Medicines …
Based on their initial evaluation, the CHMP rapporteur and co-rapporteur share their respective assessment reports with all the CHMP and PRAC members, together with a list of questions to be addressed by the applicant.
Medicines for human use under evaluation - European Medicines …
Each month, the European Medicines Agency's (EMA) publishes an updated list of medicines for human use currently under evaluation by EMA’s Committee for Medicinal Products for Human Use (CHMP) to obtain a marketing authorisation in the European Union (EU).
European public assessment reports: background and context
The European Medicines Agency (EMA) publishes detailed information on the medicines assessed by the Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP).
Assessment templates and guidance - European Medicines …
The Committee for Medicinal Products for Human Use (CHMP) and Committee on Advanced Therapies (CAT) should use the assessment report templates and documents listed below for the assessment of any new application in the centralised procedure.
CHMP members | European Medicines Agency (EMA)
The European Medicines Agency (EMA) publishes details of the members and alternates of its Committee for Medicinal Products for Human Use (CHMP).
What EMA publishes and when | European Medicines Agency (EMA)
This guide describes the different types of information EMA currently publishes for both centrally and non-centrally authorised medicines, as well as publication times and locations.
Nitrosamine impurities | European Medicines Agency (EMA)
Oct 28, 2019 · EMA's CHMP has carried out a review of the presence of a nitrosamine impurity, N nitroso-varenicline, in Champix (varenicline), a smoking cessation medicine.
Keytruda | European Medicines Agency (EMA)
Jul 30, 2015 · CHMP post-authorisation summary of positive opinion for Keytruda (II-104, II-105)
Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in the context of the centralised procedure. These inspections are adopted by the ...