Aktualności
EMA: Draft guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery
06.06.2012
This guideline is a revision of the CHMP Guideline on clinical investigation of medicinal products for Prophylaxis of Intra- and Post-operative Venous Thromboembolic Risk (CPMP/EWP/707/98 Rev.1
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EMA: Guideline on quality of biological active substances produced by transgene expression in animals
06.06.2012
This guideline provides guidance on the approaches that should be employed in order to achieve satisfactory quality for biological drug substances proposed to be produced using transgenic animal
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EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
06.06.2012
This guideline lays down the quality requirements for a biological medicinal product claiming to be similar to another one already marketed. It addresses the requirements regarding manufacturing
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GMP: New IMPD Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials
06.06.2012
The application to carry out a clinical trial (Investigational Medicinal Product Dossier, IMPD) is a document which must contain all the relevant quality information regarding the manufacture,
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EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes
31.05.2012
On 23 July 2010 and after a consultation phase, the EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any
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EMA: ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/ biological entities) Step 4
31.05.2012
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q11 on development and manufacture of drug substances
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EMA: Concept paper on the need for a guideline on multiplicity issues in clinical trials
31.05.2012
The CHMP points to consider on multiplicity issues in clinical trials came into operation in 2002. Since then, it has been proven to be useful for both, industry and regulators when planning and
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EMA: ICH guideline E14 - questions and answers
31.05.2012
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): E14 questions and answers - Step 5 ...
EMA: Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation
24.05.2012
The document clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. ...
EMA: Electronic submission of veterinary dossiers: Questions and answers
24.05.2012
This question and answer document aims to address frequently asked questions and provide guidance to applicants in regard to technical and practical aspects of the EMA’s current policy on
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