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Regulatory Review: Insight from ISPE Regulatory Advisors March 2008: Revision of EU GMP Guidelines  by Robert M. Tribe The EMEA announced on 18 February 2008 several significant revisions to the EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP Guidelines). These included revisions to Part I, Chapter 1 (Quality Management) and Annex 1 (Manufacture of Sterile Medicinal Products), as well as the inclusion of a new Annex 20 on Quality Risk Management.  Continue reading Regulatory Review Article Archives

Regulatory News:

• The Guidelines that were signed in Portland, Oregon, May 31 - June 5, 2008 are now available on the ICH website
  ICH is publishing Step 4 Tripartite Harmonised ICH Guidelines recommended for implementation and Step 2 Consensus Draft Guidelines released for open consultation.

• PIC/S Annual Report Published 
  Reports on topics including membership, operations, training of inspectors, harmonisation of guidance documents, and relations with other organizations.

• EudraLex - Volume 1
  Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission (Official Journal L 81, 20/3/2008, p. 51 - 52 ).

• Press Release - First survey on patients' involvement in the European Medicines Agency's work reveals high satisfaction levels overall 
  Over 92 % of representatives polled in a recent survey — the first of its kind since the EMEA began systematic involvement of patients and consumers in its activities — say they are either satisfied or very satisfied with their overall interaction with the EMEA, with the remaining 7 % expressing neither satisfaction nor dissatisfaction.

• Outcome of ICH Steering Committee Meeting:  "Monitoring and Protecting the Global Public Health"in Portland, Oregon on 31 May to 5 June 2008
  The International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in Portland, Oregon, from May 31st to June 5th, 2008. The main achievements are outlined in this document.

• European Commission Publishes GCP inspection guidance 
  In accordance with Article 29 of Commission Directive 2005/28/EC, in order to harmonise the conduct of Good Clinical Practice (GCP) inspections by the competent authorities of the Member States, guidance documents containing the common provisions on the conduct of those inspections shall be published by the Commission after consultation with the Member States.  In accordance with this procedure, on the basis of input from the GCP Inspectors Working Group and after consultation of the Member States, GCP guidance is now published in Chapter IV of the Eudralex Volume 10. Guidance documents can be found here.

MORE NEWS

Product Quality Lifecycle Implementation (PQLI)
PQLI is an industry-driven global initiative launched by ISPE designed to help industry find practical, global approaches to implementing ICH guidances.

• More about PQLI
• PQLI releases Draft PQLI Summary Update Report
• PQLI releases Draft PQLI Summary Update Report
• PIC/S Chairman Morénas Announces Support of ISPE’s PQLI Initiative