Comments invited on draft revised guideline on medicines for the treatment of hypertension
NewsHumanRegulatory and procedural guidance
The European Medicines Agency has released a draft revision of its Draft guideline on clinical investigation of medicinal products in the treatment of hypertension - Revision 4 for a six-month public consultation.
Comments should be made using the submission form and sent no later than 31 January 2014 to cvswpsecretariat@ema.europa.eu.
This is the fourth revision of this guideline. Its main purpose is to include more comprehensive guidance on the collection of long-term safety data and to clarify the situations in which outcome studies might be required in order to detect potential long-term effects on mortality and morbidity.