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EMA: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures

04.04.2013
This document contains revised implementing rules to the Fee Regulation as of 1 April 2013. ...

GMP: WHO\'s New Draft Guideline on Submission of Quality Data for Generic Medicinal Products

04.04.2013
The guideline provides concrete recommendation on how to submit information within the CTD structure. The document ends with an appendix about conducting and assessing comparative dissolution ...

EMA: Concept paper on the development of medicinal products for the treatment of autism spectrum disorder

04.04.2013
Autism spectrum disorders (ASDs) are a group of neurodevelopmental disabilities with symptoms typically presenting before the age of 3 years and persisting into adulthood. They are described as ...

GMP: Simplification of Application Submissions for Centrally Authorised Products

04.04.2013
The document contains important information about the delivery of applications to the competent authority in the case of new marketing authorisations, renewals, type II variations, and further ...

EMA: Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia

28.03.2013
This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic ...

Polish Ministry of Health: Project of act concerning amendment of act - Pharmaceutical law and other acts

28.03.2013
This document is a project of act concerning amendment of act - Pharmaceutical law and other acts. ...

EMA: Reflection paper on Immune Tolerance Induction in haemophilia A patients with inhibitors

28.03.2013
In haemophilia A patients, replacement therapy with factor VIII products has become state of the art. However, a serious complication in the treatment of haemophilia A is the development of ...

EMA: Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance

28.03.2013
This guideline outlines the approaches to be followed for declaring the quantitative composition/labelling of medicinal products that include modified proteins as their active substance, taking ...

EMA: Draft guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1)

21.03.2013
This guideline replaces Guideline on Modified Release Oral and Transdermal Dosage Forms Section II 9 (Pharmacokinetic and Clinical Evaluation (EMA/CPMP/EWP/280/96 Corr*)). ...

EMA: European Medicines Agency updates product information template to label medicines subject to additional monitoring and encourage adverse-reaction reporting

21.03.2013
As part of the implementation of the European Union (EU) pharmacovigilance legislation, the European Medicines Agency has updated the product-information template to allow easy identification of ...