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GMP: New EMA Guideline on Starting Materials from Biological Medicinal Products

22.08.2013
The Guideline describes the requirements for the quality documentation of module 3 of the marketing authorisation dossier. Here, the complete manufacturing process including all sources as well as ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis

08.08.2013
This document replaces and updates the previous points to consider on amyotrophic lateral sclerosis and focuses on the design of studies for disease-modifying as well as symptomatic treatments in ...

EMA: Concept paper on the development of product-specific guidance on demonstration of bioequivalence

08.08.2013
This document describes for specific products the regulatory view on specific aspects related to the demonstration of bioequivalence based on previous assessments of generic medicines. ...

EMA: Guideline on pharmaceutical development of medicines for paediatric use

08.08.2013
The “Paediatric Regulation” aims to facilitate the development and accessibility of age-appropriate paediatric medicines. This aim should be achieved without subjecting children to unnecessary ...

EMA: Reflection paper on management of clinical risks deriving from insertional mutagenesis

08.08.2013
This reflection paper is aimed at discussing the factors contributing to genotoxicity of vector integration, the strategies to reduce the risk associated to insertional mutagenesis and the assays ...

EMA: Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

01.08.2013
This document provides guidance on the data requirements to support authorisation of combined vaccines and a claim for the use of two or more IVMPs, each with its own separate marketing ...

GMP: New EMA Inspection Requirements on Good Distribution Practices (GDP)

01.08.2013
On 27 June 2013, the EU Commission updated the so-called \"Compilation of Community Procedures on Inspections and Exchange of Information\". This document serves the exchange of information and ...

FDA: Guideline - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders - General Chapter (Q4B Annex 13)

01.08.2013
The FDA finally published the ICH harmonised Guideline entitled \"Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders - ...

EMA: Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome

25.07.2013
This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of patients with Irritable Bowel Syndrome (IBS). ...

EMA: Guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence

25.07.2013
This guideline considers pharmacodynamic and clinical data required to support indications, dose regimens and durations of therapy for the treatment of urinary incontinence (UI). It applies to the ...