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GMP: GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

27.06.2013
The European Medicines Agency EMA specifies in one of its questions and answers documents on the GMP guideline under the heading \"EU GMP guide part II: Basic requirements for active substances ...

FDA: Draft Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics

27.06.2013
The provisions of this guidance, when finalized, will replace the current guidance for industry entitled Fast Track Drug Development Programs Designation, Development, and Application Review ...

FDA: Draft Guidance for Industry Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic

27.06.2013
This guidance, when finalized, will supersede the guidance entitled “Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic ...

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

13.06.2013
The principal aim of this guideline is to adapt some specific aspects of the quality guidance already in place for other recombinant production systems to the special case of transgenic animal ...

EMA: Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measure

13.06.2013
The aim of this position paper is to raise awareness for this issue, provide insight with regards to how the benefit-risk assessment of such products might be impacted and to discuss in general ...

EMA: Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure

13.06.2013
The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the ...

EMA: Guideline on good pharmacovigilance practices: Module XVI – Risk-minimisation measures: selection of tools and effectiveness indicators - draft

13.06.2013
Risk-minimisation measures are public-health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity ...

EMA: Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products - draft

13.06.2013
This module addresses the legal requirements detailed in title IX of Directive 2001/83/EC and chapter 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member ...

EMA: Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances

06.06.2013
This guideline provides recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for an antimicrobial veterinary medicinal product. Appropriate ...

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

06.06.2013
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 ...