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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 16, 2015 concerning amendment of the Official List of Medicinal Products

26.03.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 16, 2015 concerning amendment of the Official List ...

URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 19, 2015 concerning the ID Registration Office in EudraVigilance system, which are sent to isolated cases of adverse reac

26.03.2015
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 19, 2015 concerning the ID Registration Office ...

URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 23, 2015 concerning content of Supplement 8.4 of eighth edition of European Pharmacopoeia (Ph. Eur.)

26.03.2015
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of March 23, 2015 concerning content of Supplement 8.4 ...

EMA: PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine

26.03.2015
European Medicines Agency\'s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a periodic review of one of the bisphosphonate medicines with a known risk of osteonecrosis of the ...

EMA: PRAC recommends restrictions on the use of codeine for cough and cold in children

26.03.2015
European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of ...

RAPS: FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex\'s Kaldeco

26.03.2015
The US Food and Drug Administration (FDA) has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, ...

RAPS: UK Regulator Issues First Positive Opinion in Early Access Program

26.03.2015
Merck’s new skin cancer treatment has become the first product approved under a new accelerated review process by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The ...

FDA: Clinical Trial Imaging Endpoint Process Standards

19.03.2015
The purpose of this guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products.2 This ...

EMA: Draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals

19.03.2015
This guideline provides advice in regards to applications for marketing authorisations for antimicrobial veterinary medicinal products on the data required and the methodology to be used for ...

EMA: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

19.03.2015
This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate ...