New EU Draft Guideline Clarifies, Broadens and Deepens Expectations for GDPs

The EU’s new draft guideline on Good Distribution Practices (GDPs) makes a substantial contribution to the product manufacturer-to-patient component of the global regulatory community’s effort to clarify, broaden and deepen GDP regulatory expectations.

The release of the draft – out for public comment until December 31 – comes on the heels of the adoption of the “Falsified Medicines” legislation by the European Council in late May (IPQ “In the News” May 31).  The legislation includes supply chain/GDP requirements that are expounded upon in the EU draft guideline.

GDPs have been a strong point of focus among agencies, associations and pharmacopeias world-wide, which have been working to fill in the expectations for the various links in the distribution chain from raw materials through finished products to the patient.  [Editor’s note:  See IPQ “In the News” April 19 for an analysis of GDP developments around the world.]

The EU draft represents a more comprehensive treatment of GDPs on the product/patient side than other of the pharma community efforts to date.

Associations like IPEC and APIC have focused on the material supply part of the chain.  In that context, the IPEC GDP guide for excipients covers many of the same topic areas as the new EU draft, such as quality management, personnel, equipment, premises and documentation.

The WHO GDP guide released last fall is specific to temperature sensitive products, which are covered in a section in the EU draft and are also a focal point of industry and association efforts (IPQ “In the News” April 27).

The 32-page draft guideline represents a wholesale rewrite of the existing EU 4-page GDP guide published in 1992.  In the introduction to the rewrite, the European Commission deemed the original guide “no longer adequate” in the face of “advancements of practices for appropriate storage and distribution of medicinal products.”

[An analysis of the areas where the EU draft guideline advances the GDP cause is provided for subscribers here.  Nonsubscribers can purchase the full story for $95 by contacting Jonathan Trethowan (  For subscription/license information, click here.]