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Polish Ministry of Health: Project of regulation of Minister of Health concerning a way and mode of pharmacovigilance of veterinary medicinal products.

21.11.2013
This document is a project of regulation of Minister of Health concerning a way and mode of pharmacovigilance of veterinary medicinal products. ...

EMA: Second draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation

21.11.2013
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1–2% of the general population. AF confers a 5-fold risk of stroke, and one in five of all strokes is ...

EMA: New EMA guidance on development of antibacterials to help in the fight against multidrug-resistant pathogens

14.11.2013
The European Medicines Agency (EMA) released an Addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections. One of the most important ...

Polish Ministry of Health: Regulation of Polish Minister of Health of November 5, 2003 amending regulation on requirements concerning labelling packages of medicinal products and contents of the leaflet.

14.11.2013
This Regulation of Polish Minister of Health amends regulation on requirements concerning labelling packages of medicinal products and contents of the leaflet. ...

FDA: Draft guidance - Pulmonary Tuberculosis: Developing Drugs for Treatment

14.11.2013
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of pulmonary tuberculosis. Specifically, this guidance addresses the FDA’s current ...

EMA: Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders and changes to scope of European safety referrals

07.11.2013
Amendments of the European Union (EU) pharmacovigilance legislation that were adopted in October 2012 came into force on Monday 28 October 2013. These changes, which cover various aspects of the ...

EMA: European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach

07.11.2013
The European Medicines Agency (EMA) and the United States Food and Drug AdministrationExternal (US FDA) have published a second joint question-and-answer document that provides guidance on the ...

Polish Ministry of Health: Act of Sep 27, 2013 of an act amendment – Pharmaceutical Law and other acts

07.11.2013
The document concerns an amendment of pharmaceutical law. A crucial element of accepted amendments is remodelling the definition of the concept of \"adverse reaction to medicinal product\" and ...

EMA: Draft concept paper on need for revision of the guideline on medicinal products for the treatment of Alzheimer\'s disease and other dementias

07.11.2013
The proposed guideline will replace ‘Guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias’ (CPMP/EWP/553/95 Rev. 1) ...

EMA: European Medicines Agency explores ways to further involve patients in the benefit-risk assessment of medicines

31.10.2013
The European Medicines Agency has published a report of the workshop held on 26 September 2013 to discuss further development of patient involvement in the evaluation of medicines, in particular ...