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EMA: Regulatory procedural Advice on similar biological medicines

17.05.2012
In April, the European Medicines Agency (EMA) published a new document on regulatory procedural advice on similar biological medicines. This paper is supposed to complement existing guidelines by ...

EMA: eSubmission Gateway for Centralised Authorisations - Questions and answers

17.05.2012
For some time now, the EMA has only been accepting the submission of documents in electronic form for the centralised procedure. So far, there have been 2 possibilities to submit documents: either ...

EMA: Reflection paper on classification of advanced-therapy medicinal products

10.05.2012
The aim of this reflection paper is to introduce the advanced-therapy medicinal product (ATMP) classification procedure by means of clarifying the legal basis for ATMP classification, providing ...

EMA: Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

10.05.2012
The purpose of this reflection paperi is to provide laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial, with information that will help ...

Polish Ministry of Health: Regulation of Polish Minister of Health on document templates submitted in relation to the clinical trial of the medicinal product and amount and way of payment for the submission of an application for the starting point of clin

10.05.2012
This document is a Regulation of Polish Minister of Health concerning document templates submitted in relation to the clinical trial of the medicinal product and payments for the submission of an ...

Polish Ministry of Health: Regulation of Polish Minister of Health on the Good Clinical Practice

10.05.2012
This document is a Regulation of Polish Minister of Health concerning the Good Clinical Practice ...

Polish Ministry of Health: Regulation of Polish Minister of Health concerning variations in marketing authorisation and documentation regarding marketing authorisation of a medicinal product

02.05.2012
This document concerns variations in marketing authorisation and documentation regarding marketing authorisation of a medicinal product ...

Polish Ministry of Health: Regulation of Polish Minister of Health on inspection of clinical trials.

02.05.2012
This document concerns inspections of clinical trials. ...

Polish Ministry of Health: Regulation of Polish Minister of Health on inspection of veterinary clinical trials.

02.05.2012
This document concerns inspections of veterinary clinical trials ...

EMA: Draft reflection paper on clinical aspects related to tissue engineered products

26.04.2012
This reflection paper is intended as a supplement to the Guideline on human cell-based medicinal products (EMEA/CHMP/410869/2006) and gives current thinking regarding clinical aspects on TEPs. It ...