EMA: Fees for type IA variations to be due at start of procedure

The European Medicines Agency is informing marketing-authorisation holders that from 1 January 2012, fees for type IA variations will be due at the start of the 30-day procedure ...

EMA: Qualification opinion of Alzheimer’s disease novel methodologies/biomarkers in predementia AD clinical trials

In follow-up to the positive Qualification Opinion on the use of cerebrospinal fluid (CSF) biomarkers in predementia AD adopted on 14-Apr-2011 (EMA/CHMP/SAWP/102001/2011), BMS is requesting an ...

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

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

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

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

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)

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

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

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)

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 ...

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