European Fine Chemicals Group Issues Position Paper on Excipients

Milan (Oct. 3)-The European Fine Chemicals Group (EFCG, Brussels) issued a position paper on excipients used in pharmaceutical manufacturing at CPhI Worldwide last week. Arnulf Heubner, chairman of EFCG’s pharma business committee and director of pharma and food raw materials at Merck KGaA (Darmstadt, Germany) outlined the group’s position as it seeks to improve the quality and regulatory aspects for excipients used in pharmaceutical products in Europe through the adoption of certain key proposals.

“By far the largest volume and weight of any medicine consists of a range of excipients, the manufacture of which varies, is covered by limited regulation and lacks legal enforceability,” said Heubner. “I am, therefore, concerned that by allowing this situation to prevail we could be putting the health of European citizens at risk.”

The EFCG outlined that with the implementation of the EU Directive 2001/83/EC (amended by Directive 2004/27/EC) into national law, it is now mandatory that all active pharmaceutical ingredients (APIs), and the yet-to-be-defined list of “Certain Excipients” used in pharmaceutical manufacturing, must be produced in compliance with current good manufacturing practice (CGMP).

EFCG says its position paper builds on this expectation and proposes the following:

• That all “Common Excipients,” by far the largest grouping, conform to the United States Pharmacopeia’s General Chapter <1078>, including certified requirements by the International Standards Organization (ISO).

• That all “Specific Excipients” (which include “Certain Excipients”) and “Novel Excipients,” a much smaller defined group, are covered by EC Directive 2001/83 (amended by Directive 2004/27/EC), and that all these requirements are certified and effectively enforced.

“Specific Excipients” are pharmaceutically inactive substances that are associated with an increased risk potential, and therefore require an elevated degree of safety management, according to the EFCG position paper. The EFCG is proposing additional requirements and further classification, for example, for biologically derived excipients, sterile excipients, or excipients with a known track record of toxic contamination.

“Novel Excipients” are all “new chemical entities” excipients with “novel use” named in the European Medicines Agency’s draft Guideline on Excipients in the Dossier for Application for Marketing Authorization of a Medicinal Product and all “Novel Biological Excipients” according to the draft position paper by the International Pharmaceutical Council Europe on Excipient Master File Systems in Europe.

“EFCG believes that the consequences of the full implementation of their proposals not only supports the need to better protect the health of EU citizens, but it would also bring into law what is already the accepted practice for a wide range of reputable suppliers in the Far East, North  America and Europe,” according to an EFCG press release. “As such, it should have an insignificant effect on product prices.”

EFCG’s position paper on excipients may be found here.