EMA: Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2016

The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on ...

EMA: New treatment for advanced form of kidney cancer

The European Medicines Agency (EMA) has recommended extending the use of Opdivo (nivolumab) to include the treatment of adult patients with advanced renal cell carcinoma (a type of kidney cancer) ...

EMA: Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format

The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the ...

EC: Pharmacovigilance - Major developments

As of 1 February 2016 marketing authorisation holders will no longer be required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for ...

EMA: Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias

This guideline replaces \'Guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias’ (CPMP/EWP/553/95 Rev. 1). ...

EMA: EMA sets up task force on Zika virus

European experts to provide support to global response on the emerging epidemic The European Medicines Agency (EMA) has established a task force of European experts with specialised knowledge in ...

EMA: Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of the risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of chronic heart failure

This guideline addresses the EU regulatory position on the clinical development of new medicinal products in the treatment of patients with chronic heart failure (CHF). ...

EMA: Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market

In order to stimulate the development of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited ...

FDA: Completeness Assessments for Type II API DMFs Under GDUFA

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an ...

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