WASHINGTON _ Efforts at harmonizing the procedures to getdrugs to market in Europe, Japan and the U.S. have progressed to thepoint that the negotiating parties are looking into the feasibility ofcreating a common technical document that could be filed with drugapplications in all three regions.
Margaret Cone, vice president for scientific affairs for theInternational Federation of Pharmaceutical ManufacturersAssociation (IFPMA) presented the efforts being made towardcreating common technical requirements for all three regions as wellas challenges to actually getting such a document in place at theGlobal BioRx Regulatory Strategies meeting here Thursday.
"When it comes down to it, a particular drug has a set of actions anda set of adverse events," Cone said. "While there will always be somespecial requirements from each region, you shouldn't have to repeatmost studies for each region."
However, the prevailing regulatory culture in the three regionsprovides obstacles to an easy agreement on the terms of acceptabletechnical requirements that a common document would address. "Thelast thing that anyone wants is to see is a harmonizing up to thehighest possible standard," Cone said. "Clearly we want to keepsafety, but we need to keep a sensible and scientific commondenominator in the process."
The requirements, in everything from drug stability to the conduct ofclinical trials, vary so widely between Europe, Japan and the U.S.that companies trying to get drugs approved often had to perform oneset of studies for Europe and another for Japan or the U.S. As aresult, harmonization talks _ called the International Conference onHarmonization (ICH) _ were initiated in 1990. The ICH includes theregulatory bodies of each region as well as industry representativesfrom each region.
Since 1990, the talks have resulted in agreements in the form ofguidelines for testing drug stability, dose selection for toxicity testsand the means of detecting reproductive toxicity. By July, when the4th International Conference on Harmonization takes place inBrussels, the participants expect to come to an agreement on theguidelines for Good Clinical Practice.
In Brussels, the conferees will also be presented with the commontechnical document feasibility report and a potential timeline. ButCone pointed out that some important cultural differences existbetween the three countries that could slow all efforts forharmonization.
For example, the FDA seems to operate with a high level of mistrusttoward manufacturers. As a result, it requires companies to submitraw data that it then performs its own statistical analyses on. "InJapan, they have no interest in seeing the raw data," Cone said."Neither do the Europeans."
However, as a legacy of thalidomide, the Europeans do not test adrug in women of childbearing age until all of the reproductivetoxicity data is in hand. "The U.S. has more liberal standards onwhen a drug can be tested in women," said Cone.
And, in Japan, doctors are hesitant to place people on placebos,making placebo-controlled studies difficult to perform. Nevertheless,the Japanese did agree to the standards of Good Clinical Practice(GCP). "Cultural considerations made it quite a struggle for theJapanese to adopt GCP," Cone told BioWorld Today.
As difficult as it may be to get the three regions to agree to a commontechnical document, Cone maintained it can be done, even thoughcultural differences get in the way. After all, drugs don't have onesafety profile in Europe and an entirely different one across theAtlantic.
"If it looks like a duck, and it swims like a duck, and it quacks like aduck," said Cone, "there is a fairly good possibility that you aretalking about a duck." n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.