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EC: Pharmacovigilance - Major developments

14.03.2016
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

17.02.2016
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

17.02.2016
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

17.02.2016
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

17.02.2016
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

17.02.2016
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

17.02.2016
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 ...

GMP: Important Publication of the Delegated Regulation complementing the Anti-Counterfeiting Regulation

17.02.2016
On 9th February 2016 the European Union has published the \"COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the ...

RAPS: Generic Drug Review Dashboard: FDA Offers a First Look

17.02.2016
As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the ...

RAPS: EU Regulation Requires New Safety Features on Drug Packaging by 2019

17.02.2016
A new regulation will require prescription drugmakers in all but three EU countries to incorporate new safety features on their product packaging by 9 February 2019. ...