Aktualności
MHRA: Guidance published on UK national marketing authorisations (MA) variations
01.12.2009
The MHRA has produced guidance to assist those making variation applications to the MHRA as from 1 January 2010, following the implementation of a new Commission Regulation and its adoption for UK
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EMEA: Note for guidance Eudravigilance Human - Processing of safety messages and individual case safety reports (ICSRs)
25.11.2009
The purpose of this guidance is to describe the aspects of the message processing and
acknowledgment generation implemented in EudraVigilance (EV). It updates and replaces the
business rules and
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EMEA: Draft EMEA/pdco standard pediatric investigation plan for allergen products for specific immunotherapy
25.11.2009
The drafting of this standard PIP was triggered by a request from the German Competent Authorities. ...
MHRA: Reclassification of medicines
25.11.2009
MHRA recently changed the legal status and classification of several medicines. ...
EMEA: Guideline on the data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of regulation (EC) No 470/2009
19.11.2009
This guideline contains guidance relating to the data to be provided in support of a request for the CVMP to consider the inclusion of an excipient in the list of substances considered as not
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EMEA: Reflection paper on risk management plans for centrally authorised veterinary medicinal products
19.11.2009
Veterinary pharmacovigilance is in continuous development. The provision for risk management systems is new in the field of veterinary medicines and therefore gives opportunity for novel, targeted
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EMEA: Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies
19.11.2009
This guideline lays down the non-clinical and clinical requirements for monoclonal antibody-containing medicinal products claiming to be similar to another one already marketed, i.e. similar
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EMEA: Overview of comments received on draft guideline on similar biological medicinal products containing low-molecular-weight-heparins
19.11.2009
The guidance is limited to non-clinical and clinical aspects and does not address the Quality Standard aspects that biosimilar products must adhere to. This may be misunderstood as “the quality
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EMEA: Draft community herbal monograph
19.11.2009
Draft community herbal monograph on Agni casti fructus Vitex agnus castus L., fructus (agnus castus) ...
EMEA: Reflection paper in the Extrapolation of results from clinical studies conducted outside europe to the eu-population
19.11.2009
This reflection paper, including experience from a sample of applications, shows that in
particular extrinsic factors, such as medical practice, disease definition and study population,
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