PL EN

Aktualności

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 ...

EMA: mplementation plan for the introduction of the new pharmacovigilance legislation requirements into the product information of centrally approved medicinal products.

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 ...

GMP: Final GDP Guideline published by EU Commission

21.03.2013
The new GDP Guideline will apply not only to the wholesalers and manufacturers of pharmaceuticals, it also incorporates the specific requirements for the Brokers dealing with pharmaceutical ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus, cutaneous lupus and lupus nephritis

14.03.2013
The purpose of this guideline is to provide guidance on development, manufacturing and control for Marketing Authorisation Applications for influenza vaccines. The Quality Module has been updated ...

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny