"We have big concerns with the FMD because it has the potential to be a trade barrier," says John DiLoreto, executive director
of the Bulk Pharmaceuticals Task Force (BPTF) of the Society of Chemical Manufacturers and Affiliates (SOCMA), Washington,
DC. "We need to get as much international harmonization as possible with GMP. The European Commission and the FDA have got
to a point where there is not much distance between what they want. The EU then comes up with the FMD, which requires the
FDA to be exempted from the written confirmation rule."
The EC insists that it is not putting up new nontariff barriers or working outside the Q7 rules on GMP for APIs drawn up by
the International Conference on Harmonization (ICH). "These claims are completely unsubstantiated," says a Commission spokesperson.
She stressed that the introduction of equivalence regulations in the FMD, such as the written confirmation requirement, are
consistent with the rules of the World Trade Organization while the EU's GMP standards remain "equivalent" to ICH Q7 standards
and GMP standards of the World Health Organization (WHO).
Joint proposals for the EU-US trade agreement by the European and US producers of APIs are focused mainly on the issue of
GMP compliance. Three of the four proposals, put forward in a joint statement in Oct. 2012 by SOCMA, the European Fine Chemicals
Group (EFCG), and the Active Pharmaceutical Ingredients Committee (APIC) of the European Chemical Industry Council (Cefic),
deal with GMP certification, a mutual recognition agreement of GMP inspections, and regulatory assessments of process changes.
The fourth proposal focuses on the need for transatlantic harmonization of pharmacopoeia to provide more impetus to the establishment
of a global pharmacopeia standard.
On the matter of GMP certification, the joint statement emphasized the necessity of reconciling FDA's system of giving manufacturing
sites "certificates of pharmaceutical product" with the EU's detailed confirmation of GMP standards. With systems on reporting
of process modifications, there is also a need to resolve differences between the EU and US relating to what process changes
need to be reported to licensing authorities and whether they should be reported before or after the changes are implemented.
With respect to a mutual recognition agreement between the EU and the US that was first discussed in the late 1980s, the three
trade organizations (SOCMA, EFCG, and APIC) argued it would enable EU and US agencies to concentrate their efforts on GMP
inspections in third countries.
Even without the EU-US free-trade initiative, progress is already being made in bilateral cooperation across the Atlantic
on key issues. A four-year-old joint-plant-inspection program between FDA and EMA entered a second phase last year but is
still being limited to a few sites. "At least there are stakes being placed in the ground, which ought to move things forward,"
says Tony Scott, adviser to the EFCG. Since 1989, the European Directorate for the Quality of Medicines (EDQM), which is responsible
for the European Pharmacopoeia, and its US counterpart the United States Pharmacopeia (USP) have been drawing up mutually
recognized monographs on drugs. Both are participating in a scheme, launched last year by WHO, for global pharmacopoeia standards.
"Out of a total of 2200 monographs, we and the USP have so far harmonized less than 100," says Susanne Keitel, EDQM secretary.
"Harmonization entails a lot of hard work."
For the EU–US free-trade negotiations, the major target will be to achieve a mutual recognition agreement because of its implication
for worldwide recognition of inspections. "The talks on the transatlantic trade agreement has given us an opportunity to reopen
dialogue to try to achieve an EU–US mutual recognition agreement," says Scott. "If successful, it could be the first in a series to eventually cover the global
pharmaceutical industry." The vision is for the global pharmaceutical industry to have a global GMP inspection system. Perhaps
the EU–US free-trade deal would kick start crucial moves towards realizing it.
Sean Milmo is a freelance writer based in Essex, UK, firstname.lastname@example.org