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EMA: Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

30.11.2011
This document provides guidance on the data requirements to support authorisation of combined vaccines and a claim for the use of two or more IVMPs, each with its own separate marketing ...

EMA: Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines

30.11.2011
This document provides information on items to be considered in the design and conduct of studies to support the safety and efficacy of immunological veterinary medicinal products (IVMPs) in ...

FDA: Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals

30.11.2011
The objective of this guidance is to provide recommendations to industry for designing nonclinical late radiation toxicity studies to determine potential late radiation effects of therapeutic ...

GMP: USP publishes First Ten Quality Standards in New Medicines Compendium

30.11.2011
On November 28, 2011 the United States Pharmacopeial Convention (USP) published the first ten standards for the USP Medicines Compendium (MC). The MC is a free, online source of public standards ...

EMA: Overview of comments received on \'Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1)

24.11.2011
Interested parties (organisations or individuals) that commented on the draft document as released for consultation. ...

EMA: Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) - adopted

24.11.2011
This Appendix contains a set of template tables to assist applicants in the preparation of Module 2.7.1 providing guidance with regard to data to be presented. Furthermore, it is anticipated that ...

GMP: WHO issues revised version of HVAC Guide

24.11.2011
The Guideline of the WHO that was initially issued in 2006 targets HVAC systems operated in non-sterile production sites, and predominantly in production of solid dosage forms. The issued version ...

EMA: Concept paper on the revision of the guideline on similar biological medicinal product – draft (consultation open)

24.11.2011
The so-called “overarching” guideline on similar biological (biosimilar) medicinal products CHMP/437/04 was discussed in CHMP in 2004 and, after external consultation, came into force ...

EMA: Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH) - consultation open

24.11.2011
This guideline lays down the non-clinical and clinical requirements for recombinant human follicle stimulating hormone (r-hFSH)-containing medicinal products claiming to be similar to another one ...

EMA: Concept paper on Revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release

17.11.2011
Annex 16 of the Guide to Good Manufacturing Practice for Medicinal Products gives guidance on the certification and batch release of medicinal products within the European Union and European ...

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