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EMA: Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems

28.06.2012
This Module contains guidance for the establishment and maintenance of quality assured pharmacovigilance systems for marketing authorisation holders, competent authorities of Member States and the ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file

28.06.2012
The pharmacovigilance system master file is a legal requirement in the EU. This guidance concerns the requirements for the pharmacovigilance system master file and is applicable for any medicinal ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems

28.06.2012
The purpose of risk identification and characterisation is to allow for risk minimisation or mitigation wherever possible. ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products

28.06.2012
This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and Chapter 3 of Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report

28.06.2012
Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies

28.06.2012
A post-authorisation safety study (PASS) is defined in Directive 2001/83/EC (DIR) Art 1(15) as any study relating to an authorised medicinal product conducted with the aim of identifying, ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module IX – Signal management

28.06.2012
For the purpose of this Module, only new information related to adverse effects will be considered. In order to suggest a new potentially causal association or a new aspect of a known ...

EMA: Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues

21.06.2012
This guideline lays down the non-clinical and clinical requirements for monoclonal antibody (mAb) containing medicinal products claiming to be similar to another one already authorised. The ...

EMA: Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use.

21.06.2012
This guideline addresses issues relating to the unwanted immunogenicity of monoclonal antibodies (mAbs) intended for clinical use. These include factors impacting on immunogenicity of mAbs, ...

EMA: Concept paper on the need of the guideline on clinical investigation of medicinal products for the treatment of gout

21.06.2012
At present no Committee for Medicinal Products for Human Use (CHMP) guideline has been developed for the clinical development of medicinal products aiming at prevention and / or treatment of gout ...