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FDA: Safety Assessment for IND Safety Reporting

11.01.2016
This document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products2 developed ...

FDA: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

11.01.2016
This guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with ...

REUTERS: India adds more cancer, HIV/AIDS drugs to essential medicines list

11.01.2016
India has revised its list of essential medicines to add drugs for diseases ranging from cancer and HIV/AIDS to hepatitis C, in a move aimed at making them more affordable. The update to the ...

EMA: Draft concept paper on the revision of the reflection paper on non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha

11.01.2016
The current reflection paper on similar medicinal products containing recombinant interferon alpha provides recommendations for the non-clinical and clinical development of recombinant interferon ...

URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 28, 2015 concerning the new recommendations aimed at minimizing the risk of a rare infection PML, and one of the types

11.01.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 28, 2015 concerning the new recommendations aimed ...

EMA: Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)

29.12.2015
Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC). ...

EMA: Regulatory information – Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

29.12.2015
As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for ...

EMA: Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted

29.12.2015
The European Medicines Agency (EMA) will not accept the replacement of a pivotal clinical study that has been found to be non-compliant with good clinical practice (GCP) by another study during ...

EMA: Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: biological medicinal products

29.12.2015
Product- or Population-Specific Considerations II: biological medicinal products. ...

RAPS: Proposed Rule Would Revise Regulations on Fixed-Combination Drugs

29.12.2015
The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and ...