MHRA: Guidance published on UK national marketing authorisations (MA) variations

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 ...

EMEA: Note for guidance Eudravigilance Human - Processing of safety messages and individual case safety reports (ICSRs)

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 ...

EMEA: Draft EMEA/pdco standard pediatric investigation plan for allergen products for specific immunotherapy

The drafting of this standard PIP was triggered by a request from the German Competent Authorities. ...

MHRA: Reclassification of medicines

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

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 ...

EMEA: Reflection paper on risk management plans for centrally authorised veterinary medicinal products

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 ...

EMEA: Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies

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 ...

EMEA: Overview of comments received on draft guideline on similar biological medicinal products containing low-molecular-weight-heparins

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 ...

EMEA: Draft community herbal monograph

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

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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