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HMA: BEST PRACTICE GUIDE ARTICLE 46 – PAEDIATRIC REGULATION

19.07.2010
This document was produced by the CMDh in order to facilitate the assessment of information about nationally authorised medicinal products (including MRP and DCP) in a harmonised and practical way ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

19.07.2010
This annex is the result of the Q4B process for the Bulk Density and Tapped Density of Powders General Chapter. ...

FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

19.07.2010
This annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. ...

EMA: Summary report on the EMA workshop on stem cellbased therapies London

02.07.2010
The European Medicines Agency (EMA) assembled for the first time European and international experts from academia, regulatory authorities (Europe, Japan, United States and others) and ...

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 ...

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 ...

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 ...

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 ...