News
GMP: FDA - New draft guidances for Biosimilars
08.03.2012
On 9 February the US Food and Drug Administration published three draft guidance documents on the development of biosimilar products. The intention of these documents is to meet the demands of the
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GMP: EMA Reflection Paper on Sourcing Biological Starting Materials
08.03.2012
After the FDA has recently published a draft Guidance on Monitoring Crude Heparin for Quality, the European Medicines Agency EMA has now drafted a Reflection Paper on the use of starting materials
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EMA: Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products
01.03.2012
In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product. ...
EMA: Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population
01.03.2012
The aim of this document is to highlight the lack of clinical studies on the majority of herbal medicinal products in children and the need for initiatives to stimulate the conduct of clinical
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EMA: Concept paper on the need to revise the points to consider on adjustment for baseline covariates
01.03.2012
The Committee for Medicinal Products for Human Use points to consider on adjustment for baseline covariates came into operation in 2003. Since then, they have been widely used by both industry and
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EMA: Reflection paper on risk management plans for centrally authorised veterinary medicinal products
23.02.2012
The current legislation foresees that the applicant may need to develop and describe in detail a risk management system for inclusion in the application before a marketing authorisation can be
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EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes
23.02.2012
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: Guidelines on good pharmacovigilance practices (GVP) Introductory cover note to the public consultation of the first seven modules
23.02.2012
New legislation for pharmacovigilance will apply in the European Union (EU) as of July 2012, and to support its implementation a new set of guidelines for the conduct of pharmacovigilance in the
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Polish Ministry of Health: Regulation of Polish Minister of Health concerning duties of entrepreneurs having wholesale marketing authorization of category 1 precursor chemicals and the conditions that marketing holder must fulfil.
16.02.2012
Regulation of Polish Minister of Health concerning duties of entrepreneurs having wholesale marketing authorization of category 1 precursor chemicals and the conditions that marketing holder must
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EMA: Concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products
16.02.2012
Currently, there is limited information on the utilisation of a genomic biomarker during follow up (post marketing) or on the effect of labelling with genomic information. Therefore, guidance is
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