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

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

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 ...

GMP: MHRA announces Good Clinical Practice (GCP) Discussion Forum

The U.K. Medicines and Healthcare products Regulatory Agency MHRA has created a GCP Discussion Forum to help all those involved in the conduct of clinical trials implement quality procedures that ...

EMA: Concept Paper on the Update of Guidance on the Clinical Development of Medicinal Products for the Treatment of HIV

The present EMA guidance was adopted in 2008. The main circumstance prompting the need for updated guidelines is the changing landscape of HIV treatment following the licensing of new treatment ...

GMP: European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation

Last year, the European Medicines Agency (EMA) announced in a \"Concept Paper\" that they would revise their Note for Guidance on Process Validation from 2001 and focus on the product lifecycle. ...

EMA: Concept paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities

The Safety Working Party recommends drafting new guidance on toxicological assessment to be used in the risk identification stage of the Quality Risk Management process in determining whether a ...

GMP: FDA publishes List of Guidance Documents for Medical Devices

The FDA published a list in the Federal Register presenting documents regarding the regulation of medical devices which are to be considered for development in the fiscal year 2012 (October 2011- ...

FDA: Q8, Q9, and Q10 Questions and Answers

Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) ...

EMA: Concept paper on the need for revision of the position paper on indications for veterinary vaccines

The revised position paper on indications for veterinary vaccine (EMEA/CVMP/042/97-Rev.1-FINAL) was adopted by the CVMP in June 2003. This paper presents the standard statements that should be ...

EMA: ICH guideline E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - implementation guide - data elements and message specification

This document is a guide for implementing ICH1 requirements for the electronic transmission of Individual Case Safety Reports (ICSRs) according to the ICH E2B(R3) message standard. This ...

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny