EMEA Consultation

Clinical Investigation of Medicinal Products in the Treatment of Hypertension (CPMP/EWP/238/95 Rev. 3)

The European Medicines Agency (EMEA) has published a draft guideline on 'CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE TREATMENT OF HYPERTENSION' (CPMP/EWP/238/95 Rev. 3). The document is available here:

http://www.emea.europa.eu/pdfs/human/ewp/023895endraft.pdf

The draft guideline is focused on the design of clinical studies considered to be of relevance for the evaluation of antihypertensive drugs. The current revision concerns Fixed Combinations in therapeutic doses for first line therapy.

We would be grateful if you could disseminate this document to anyone who might be interested in this topic.

Please provide any comments you may have on draft guideline to the Efficacy Working Party secretariat (EWPSecretariat@emea.europa.eu) by using this template:

http://www.emea.europa.eu/pdfs/human/regaffair/submitcomment.doc

Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders (EWP/566/98 Rev. 2)

The European Medicines Agency (EMEA) has published a draft guideline on 'CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE TREATMENT OF EPILEPTIC DISORDERS' (EWP/566/98 Rev. 2). The document is available here:

http://www.emea.europa.eu/pdfs/human/ewp/056698endraft.pdf

This document is a second revision of the existing guideline. It should be considered as general guidance on the development for medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMEA and ICH guidelines, which may apply to these conditions and patient populations.

We would be grateful if you could disseminate this document to anyone who might be interested in this topic.

Please provide any comments you may have on draft guideline to the Efficacy Working Party secretariat (EWPSecretariat@emea.europa.eu) by using this template:

http://www.emea.europa.eu/pdfs/human/regaffair/submitcomment.doc

The Development of Medicinal Products for the Treatment of Alcohol Dependence (CHMP/EWP/20097/2008)

The European Medicines Agency (EMEA) has published a draft guideline on 'THE DEVELOPMENT OF MEDICINAL PRODUCTS FOR THE TREATMENT OF ALCOHOL DEPENDENCE' (CHMP/EWP/20097/2008). The document is available here:

http://www.emea.europa.eu/pdfs/human/ewp/2009708endraft.pdf

The aim of the draft guideline is to provide guidance in the definition of treatment goals, study design, outcome measures, and data analysis for new products that will be developed to treat alcohol dependence.

We would be grateful if you could disseminate this document to anyone who might be interested in this topic.

Please provide any comments you may have on draft guideline to the Efficacy Working Party secretariat (EWPSecretariat@emea.europa.eu) by using this template:

http://www.emea.europa.eu/pdfs/human/regaffair/submitcomment.doc

The Need for the Development of a Paediatric Addendum to the CHMP Guideline on the Clinical Investigations of Medicinal Products for the Treatment of Pulmonary Arterial Hypertension (CHMP/EWP/644261/2008)

The European Medicines Agency (EMEA) has published a concept paper on 'THE NEED FOR THE DEVELOPMENT OF A PAEDIATRIC ADDENDUM TO THE CHMP GUIDELINE ON THE CLINICAL INVESTIGATIONS OF MEDICINAL PRODUCTS FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION'(CHMP/EWP/644261/2008). The document is available here:

http://www.emea.europa.eu/pdfs/human/ewp/64426108en.pdf

The aim of the concept paper is to provide guidance to industry when performing trials to develop PAH drugs. It should also provide a clear basis for the CHMP when assessing data from paediatric studies for PAH drugs.

We would be grateful if you could disseminate this document to anyone who might be interested in this topic.

Please provide any comments you may have on draft guideline to the Efficacy Working Party secretariat (EWPSecretariat@emea.europa.eu) by using this template:

http://www.emea.europa.eu/pdfs/human/regaffair/submitcomment.doc

The Need for the Development of a Paediatric Addendum to the CHMP Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (CHMP/EWP/7895/2009)

The European Medicines Agency (EMEA) has published a concept paper on 'THE NEED FOR THE DEVELOPMENT OF A PAEDIATRIC ADDENDUM TO THE CHMP NOTE FOR GUIDANCE ON THE CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE TREATMENT OF LIPID DISORDERS' (CHMP/EWP/7895/2009). The document is available here:

The aim of the concept paper is to provide guidance to industry when performing trials to develop lipid lowering drugs. It should also provide a clear basis for the CHMP when assessing data from paediatric studies for lipid-lowering drugs.

We would be grateful if you could disseminate this document to anyone who might be interested in this topic.

Please provide any comments you may have on draft guideline to the Efficacy Working Party secretariat (EWPSecretariat@emea.europa.eu) by using this template:

http://www.emea.europa.eu/pdfs/human/regaffair/submitcomment.doc