Adopted guidelines by CHMP: February 2015 updates

By William Chin, PhD, Project Manager, EUCRAF

The European Medicines Agency (EMA) regularly publishes guidelines which have been adopted during the Committee for Medicinal Products for Human Use (CHMP). These adopted guidelines form part of volume 3 of EudraLex. The documents are normally published on the EMA’s website under Regulatory/Human/Scientific guidelines.

Below is the compilation of the latest adopted guidelines during the CHMP meeting 23-26 February 2015. The complete list of adopted guidelines, question and answer documents and concept papers are available at the source listed below.

Reference number Document
EMA/CHMP/295050/2013 Guideline on adjustment for baseline covariates in clinical trials 
EMA/CHMP/BPWP/143744/2 011 rev. 1  Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration 
EMEA/CHMP/BMWP/32775/ 2005 Rev. 1  Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues 
EMA/CHMP/206815/2013 Paediatric Addendum to the Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Hypertension 
EMA/CHMP/51230/2013  Guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis 


1. EMA News and Events, 9 March 2015, Guidelines and concept papers adopted during the CHMP meeting 23-26 February 2015