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EMA: Scientific guideline: ICH: Q 3 C (R4): Impurities: Residual solvents - Step 5, adopted

19.07.2010
The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and ...

EMA: Reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors

19.07.2010
The aim of this paper is to discuss quality, non-clinical and clinical issues that should be considered during the development of medicinal products derived from AAV, and to indicate requirements ...

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) ...