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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 ...

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

17.11.2011
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

17.11.2011
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

17.11.2011
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. ...