Several Drug Substance Guideline Initiatives Moving Forward in Europe and ICH

Europe and ICH have several guideline initiatives underway that will help clarify and harmonize the regulatory expectations for drug substances and the control of their impurities.

In various stages in the development and clearance process in the EU are new or re-drafted guidelines on: ● the active substance master file (ASMF) ● pediatric formulations, and ● specifications for impurities in antibiotics.

Implementation of the API portion of the falsified medicines legislation is also now drawing European attention.

ICH meanwhile is advancing its drug substance regulatory guidance in the areas of: ● heavy metal impurities (Q3D) ● mutagenic materials (M7), and ● development and manufacturing (Q11).

The consultation periods for EMA’s guidelines on the development of pediatric formulations and on antibiotic impurities ended in 2011.  Its ASMF document is currently out for consultation.

ICH released the Step 2 draft of Q11 for comment last summer.  The expert working group (EWG) digested the comments and completed a redraft of the document at its meeting in Seville in November.  Q11 is now at the regulatory authorities in the three regions for Step 4 approval (IPQ “The News in Depth” December 12, 2011) . Work also took place at the meeting on ICH Q3D and M7, which have not yet been released for public comment.

[CLICK HERE for the complete story.and includes insights on the initiatives from a key EMA and ICH working group member involved with the API initiatives.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (  For subscription/license information, click here. ]

See related coverage:

ICH Q11 Nears Final Approval After Comments Prompt Changes in Step 2 Draft

ICH “Points to Consider” Part Two on Implementing Q8-10 Addresses Models, Design Space and Process Validation

IPQ Special Report Nov./Dec. 2008 (pp. 37-39 on heavy metals)

IPQ Special Report May 2010 (pp. 5-6 on Q3D)