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EMA: Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health

20.12.2012
Pleuromutilins are active against Gram-positive bacteria such as streptococci and staphylococci, anaerobic bacteria and Mycoplasmata. They have been used for decades in veterinary medicine for the ...

GMP: New Concept Paper on Annex 17 of the EU GMP Guide

13.12.2012
The European Medicines Agency EMA has published a draft concept paper on the revision of Annex 17 (Parametric Release). \"The GMP/GDP Inspectors Working Group recommends that the current version ...

GMP: EMA publishes Concept Paper on the Revision of Annex 15

13.12.2012
In November 2012, the EMA released a Concept Paper of 3 pages on the revision of Annex 15. The introduction presents the reasons why the EMA has planned the revision: significant changes in the ...

FDA: Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs

13.12.2012
This guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides ...

EMA: Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and / or intramuscular administration (SCIg / IMIg)

06.12.2012
This guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for subcutaneous or intramuscular use (SCIg / ...

EMA: Draft guideline on the clinical investigation of hepatitis-B immunoglobulins

06.12.2012
This guideline describes the information to be documented when an application is made for a marketing authorisation for a hepatitis-B immunoglobulin. The guidance covers biological data, ...

MHRA: Preclinical Assessment of Investigational Cellular and Gene Therapy Products

06.12.2012
The diverse biology and clinical indications and the rapid and fluid state of the evolving scientific research into these product areas pose unique scientific challenges in terms of regulatory ...

EMA: Reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference active substance

29.11.2012
The scope of this paper is restricted to consideration of differences between a single enantiomer, a complex, a derivative or a different salt or ester and the corresponding reference active ...

EMA: Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems

29.11.2012
This Reflection Paper is concerned with public health crises that arise due to unforeseen disruptions within the manufacturing process, caused by manufacturing/GMP compliance problems and ...

GMP: ECA publishes Good Practice Guide on Process Validation

29.11.2012
Since the FDA has revised its \"old\" Validation Guidance in 2011, validation has become a life cycle process with focus on process knowledge and process understanding based on scientific sound ...

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