EDQM’s Efforts to Clarify Starting Material Expectations Include Internal Policy Guide; SM Dialogue Continues

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has been working hard to better define its policies around starting materials in view of their impact on the regulation of active pharmaceutical ingredients (APIs).

In the wake of a stakeholder-wide forum, EDQM has developed an internal starting material (SM) policy guide that addresses issues that have been recurrent between regulators and industry and provides a framework to help reviewers and inspectors take a more uniform approach to their assessments.

The EDQM policy guide has the endorsement of the EMA Quality Working Party and thus provides guidance that can be used by all quality assessors across Europe.  It was approved in November by EDQM’s Certifications Steering Committee.

While the guide is not publicly available, EDQM Certification Division Head Helene Bruguera reviewed its contents at the annual meeting of the European-based Active Pharmaceutical Ingredient Council (APIC) held in Munich, Germany in November. [Editor’s note:  Bruguera’s remarks on the policy guide and starting material issues are included in full below.]

In addition to her review of the policy guide and EDQM’s recent experience with application review that it reflects, Bruguera also addressed: ● the current SM guidance available to industry ● starting materials vs. intermediates ● the definition of “synthetic step” ● the use of purchased complex starting materials, and ● the need to harmonize application assessments across reviewers.

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See related stories:

Look Forward, Not Backward, in API Process for Impurity Risks, Industry Experts Urge EU Regulators

Control of Heparin Starting Material Draws Guidance from Both FDA and EMA

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

IPQ Nov./Dec. 2007 Special Report [Editor’s note: The IPQ report provides an in-depth analysis of the regulatory issues around starting materials that continue to drive the agency/industry dialogue.]