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EMA: Regulatory and procedural guideline: Centralised procedures and MRL procedures. Recommended submission dates for new and extension applications

04.08.2010
Centralised procedures and MRL procedures Recommended submission dates for new and extension applications ...

EMA: Scientific guideline: Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

04.08.2010
This Guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance ...

EMA: Clinical efficacy and safety: Radiopharmaceuticals and Diagnostic Agents

04.08.2010
Clinical efficacy and safety: Radiopharmaceuticals and Diagnostic Agents ...

EMA: Safety monitoring of medicines: overview of the Agency’s activities

19.07.2010
Before a medicine is authorised for use, any experience of its safety and efficacy is limited to its use in clinical trials. Therefore, at the time of a medicine’s authorisation, it will only ...

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 ...