Aktualności
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
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Polish Ministry of Health: Draft regulation of Polish Minister of Health on medicines that may be treated as pharmaceutical raw materials at preparing prescription medicines.
26.04.2012
This draft concerns medicines which may be treated as pharmaceutical raw materials at preparing prescription medicines. ...
EMA: Questions and answers on the review of somatropin-containing medicines
26.04.2012
The European Medicines Agency has completed a review of the safety and effectiveness of somatropin-containing medicines. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has
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EMA: Draft guideline on process validation
19.04.2012
This guideline replaces the previous guideline on process validation. The guideline is brought into line with International Conference on Harmonisation of Technical Requirements for Registration
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EMA: Reflection paper on ethical and good-clinical-practice aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU)/European Economic Area and submitted in marketing-authorisation applications to the EU
19.04.2012
The scope of this Reflection Paper is to clarify the practical application of requirements for clinical trials conducted outside of the EU/EEA and submitted in Marketing Authorisation Applications
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EMA: Guideline on real-time release testing (formerly guideline on parametric release)
19.04.2012
This guideline addresses the requirements for application of RTRT to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR
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