World Heart Day – more guidance for medicines developers
The European Medicines Agency supports World Heart Day, which is taking place on Sunday 29 September 2013.
The Agency plays an important role in the authorisation of medicines to treat heart disease, recommending the authorisation of a number of medicines in the European Union (EU) for cardiovascular diseases.
The Agency also publishes guidelines describing how studies of medicines for the treatment of cardiovascular disease should be designed and carried out. Such guidelines are intended to help pharmaceutical industry and public institutions carry out clinical research in this domain.
The Agency’s Cardiovascular Working Party (CVSWP), which is composed of European experts selected from or associated with the EU national agencies with specific expertise in cardiovascular disease, is in the process of developing or revising a number of guidance documents in this area:
- it is revising the current guideline on clinical investigation of medicines for the treatment of acute heart failure. The new draft guideline will be released for public consultation within the next few months;
- it has released a draft guideline on clinical investigation of medicines in the treatment of hypertension, including recommendations regarding the need for outcome studies. Written comments are invited until 31 January 2014. In addition, the CVSWP has developed a paediatric addendum to this guideline to highlight the specific aspects of hypertension in children and adolescents and provide specific regulatory guidance on the clinical development of antihypertensive drugs in this population. The draft addendum will be released for a six-month public consultation on 30 September 2013;
- in the area of venous thromboembolism (VTE), in May 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a final guideline on clinical investigation of medicines for the prevention of VTE in patients undergoing high VTE-risk surgery. In addition, a concept paper on the need for revision of the guideline on clinical investigation of medicines for the treatment of venous thromboembolic disease was released in June for a public consultation open until 1 September 2013.
About World Heart Day
World Heart Day is held each year on 29 September and is dedicated to informing people around the globe that heart disease and stroke are the world’s leading cause of death. This year’s theme will focus on a life-course approach to the prevention and control of cardiovascular disease with a focus on women and children.
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- World Heart Day
- Cardiovascular diseases
- Cardiovascular Working Party
- Scientific guidelines: Clinical efficacy and safety: Cardiovascular system
- Draft guideline on clinical investigation of medicinal products in the treatment of hypertension (31/07/2013)
- Draft guideline on clinical investigation of medicinal products for the treatment of acute heart failure (15/10/2012)
- Draft guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery (30/05/2012)