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

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 ...

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.

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

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 ...

EMA: Draft guideline on process validation

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

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)

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

With our GMP News from 29 February 2012 about FDA\'s Draft Guidance on the qualification of Heparin manufacturers, we\'ve informed you about the latest FDA requirements.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

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

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

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. ...

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