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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, ...

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 ...

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 ...

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 ...

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 ...

EMA: Draft guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery

06.06.2012
This guideline is a revision of the CHMP Guideline on clinical investigation of medicinal products for Prophylaxis of Intra- and Post-operative Venous Thromboembolic Risk (CPMP/EWP/707/98 Rev.1 ...

EMA: Guideline on quality of biological active substances produced by transgene expression in animals

06.06.2012
This guideline provides guidance on the approaches that should be employed in order to achieve satisfactory quality for biological drug substances proposed to be produced using transgenic animal ...