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EMA: Draft guideline on the adventitious agent safety of urine-derived medicinal products

28.11.2013
Human urine is used to prepare several products indicated in the field of endocrinology, such as human chorionic gonadotropin (hCG), human menopausal gonadotropin or menotropin (HMG) and ...

URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning conveying applications regarding serious adverse reaction of medicinal products from Office for Registration to MAH.

28.11.2013
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning conveying applications regarding serious ...

GMP: Guidelines on GDP revised

28.11.2013
Only eight months after their publication, the Guidelines from 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use have been revised. ...

EMA: EMA promotes consistent development of bioequivalence studies through product-specific guidance

21.11.2013
The European Medicines Agency has released its first product-specific guidance on the demonstration of bioequivalence for 16 active substances. ...

EMA: Second draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)

21.11.2013
It became apparent during assessment of Symphytum officinale (monograph EMEA/HMPC/572844/2009) that the risk assessment of pyrrolizidine alkaloids (PAs) poses considerable difficulties, with ...

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 ...