Aktualności
MHRA: Best practice in classification of Individual Case Safety Reports (ICSRs)
02.07.2010
The data quality of ICSRs is an issue that affects all stakeholders and has important consequences for signal detection. To improve standards and support consistent coding practices a best
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FDA: Bioequivalence Recommendations for Specific Products
02.07.2010
This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug
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Polish Ministry of Health: Regulation project concerning the changes in The Decree of Ministry of Health relating to the payment for Marketing Authorization of the medicinal products
02.07.2010
Regulation project concerning the changes in The Decree of Ministry of Health relating to the payment for Marketing Authorization of the medicinal products. ...
EMA: Updated template for letter of intent for request of Scientific Advice / Protocol Assistance
30.06.2010
Letter of intent for request of Scientific Advice (SA) / Protocol Assistance (PA) ...
EMA: Workshop outcome and recommendations: Current use and future needs of radiopharmaceuticals labelled with radionuclides produced in reactors and possible alternatives
30.06.2010
In August 2008, the Dutch Authorities made the European Medicines Agency aware of potential shortages of radiopharmaceuticals due to the temporary shutdown of the High Flux Reactor (HFR) in Petten
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EMA: Updated EMA Post-authorisation procedural advice guidance
30.06.2010
This guidance addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the EMA position on issues, which
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EMA: Draft guideline on detection and management of duplicate individual cases and individual case safety reports (ICSRs)
29.06.2010
Duplicate cases can pose significant problems for analysing signals arising from pharmacovigilance databases, both artificially inflating and masking signals of disproportionate reporting. The
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EMA: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
29.06.2010
This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans. Its
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Questions & Answers - The use of eCTD on MRP/DCP
08.06.2010
Questions & Answers covering issues of eCTD dossier submission and handling under the new variations regulation. ...
Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure
08.06.2010
The allocation of the Variation procedure number is partly in the hands of the MAH. This guide will give detailed guidance on this issue. ...
