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Regulatory Focus™ > News Articles > EMA Adopts Addendum to CHMP Guideline on PAH Products

EMA Adopts Addendum to CHMP Guideline on PAH Products

Posted 08 February 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) adopted on 7 February the Paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension (PAH).

The addendum includes guidance on how to develop PAH products for pediatric populations, including points of distinction to be made between idiopathic PAH and associated PAH, ethical issues, considerations for trial selection, feasible trial endpoints, trial design and how to conduct pediatric trials without having adult PAH data.

The addendum comes in to effect on 5 June 2012.


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