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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 ...

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 ...

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 ...

GMP: New EMA Reflection Paper on Heparin and further Biological Starting Materials

12.04.2012
With our GMP News from 29 February 2012 about FDA\'s Draft Guidance on the qualification of Heparin manufacturers, we\'ve informed you about the latest FDA requirements. The link given in the FDA ...

GMP: FDA: Ensuring the Safety of Vaccines in the United States

12.04.2012
On 2 April, the FDA posted the current updates on \"Ensuring the Safety of vaccines in the United States\" and on \"Understanding the Vaccine Adverse Event Reporting System (VAERS)\". ...

FDA: Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography

12.04.2012
This guidance represents the Food and Drug Administration\'s (FDA\'s) current thinking on this topic. It is intended to help manufacturers of positron emission tomography (PET) drugs meet the ...

GMP: FDA publishes Draft Guidance on Clinical Studies for Medical Devices

05.04.2012
At the end of 2011 the FDA published 2 draft guidance documents on clinical studies for medical devices. In addition to that, the FDA announced a pilot programme for the latter draft guidance. ...

GMP: The new role of the Responsible Person for Good Distribution Practices

05.04.2012
The European Commission is currently revising the \'Guideline on Good Distribution Practice of Medicinal Products for Human Use\". The current Guideline was first published in 1994. The new ...

GMP: Significant Changes in HPLC System Suitability: New USP Provisions Planned

05.04.2012
A revision of General Chapter on Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on system suitability tests (SST). ...

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

29.03.2012
The purpose of this reflection paper 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 them ...