Aktualności
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
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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
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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,
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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
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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
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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,
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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
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EMA: Questions and answers on the suspension of the marketing authorisations for oral meprobamate-containing medicines
14.06.2012
The European Medicines Agency has completed a review of the safety and effectiveness of oral meprobamate-containing medicines, due to serious side effects seen with the medicine. The Agency’s
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EMA: Concept paper on the revision of the CHMP points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome
14.06.2012
The proposed guideline will replace \'points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome CPMP/EWP/785/97\'. Irritable bowel syndrome (IBS) is
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EMA: Concept paper on the need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function
14.06.2012
The note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function (CHMP/EWP/225/02) provides recommendations on when to conduct
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