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 Organization for Standardization.
- 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
"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 also would 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."
-Patricia Van Arnum
Proposed Legislation Calls for Import User Fee
US House Representative John D. Dingell (D-MI), chairman of the Committee on Energy and Commerce, along with Reps. Frank Pallone
(D-MI), chairman of the Subcommittee on Health, and Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations,
introduced legislation on Sept. 20 that would create a user fee on imported drug and food shipments.
"Increasing reports of contaminated imports have made it clear that the FDA does not have the resources and authority it needs
to ensure the safety of our food and drug supply," said Dingel in a prepared statement. "This puts every American consumer
The Energy and Commerce Committee is conducting an investigation into the safety of the nation's drug and food supply, particularly
the ability of the US Food and Drug Administration to adequately conduct inspections and perform laboratory analysis. The
legislation, H.R. 3610, the "Food and Drug Import Safety Act of 2007," would specifically create a user fee on imported drug
and food shipments. Funds generated by the fee would be used to hire additional personnel to perform inspections to increase
analysis of drug and food imports. Funds would also be used to test import samples and research new testing techniques.
The legislation would also prevent the Secretary of Health and Human Services from closing or consolidating any of the current
13 FDA field laboratories and grant the agency new authority to:
- Issue mandatory recalls
- Require country-of-origin labeling for drugs, medical devices, and food
- Halt imports of certain products until a foreign facility can demonstrate that significant steps have been taken to rectify
an identified problem
- Increase civil monetary penalties for manufacturers or importers that violate the Federal Food, Drug and Cosmetic Act.
Alan Goldhammer, deputy vice-president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA),
testified on the proposed legislation in late September. "While PhRMA believes that the United States drug distribution system
is the safest in the world ... some steps ... will further secure the pharmaceutical supply chain." For example: increasing
requirements for repackagers; strengthening federal requirements for wholesalers–distributors; and increasing criminal penalties
for counterfeiting activities.
Patricia Van Arnum