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INTERNATIONAL DRUG STABILITY REQUIREMENTS COULD DELAY ANDA SUBMISSIONS

Executive Summary

INTERNATIONAL DRUG STABILITY REQUIREMENTS COULD DELAY ANDA SUBMISSIONS by as much as nine months, FDA Office of Generic Drugs Associate Director for Chemistry Robert Jerussi cautioned Jan. 28 at the National Association of Pharmaceutical Manufacturers annual meeting in Naples, Fla. Jerussi outlined the differences between European Community/Japan/U.S. ("tripartite") International Conference on Harmonization (ICH) proposed requirements and FDA's current requirements for testing drug stability and impurities. The first draft of "extension of the tripartite stability guideline to cover marketing applications for generic drug products" was issued in October 1992. The FDAer pointed out that the tripartite guideline calls for three batches of a generic drug to undergo stability studies for six months under accelerated conditions (40 degrees Celsius, 75% relative humidity), while OGD requires one bio batch to be tested for three months. OGD does not require stability testing under real-time conditions, while the ICH guideline requires that two of the three batches be tested for 12 months at 25 degrees Celsius and 60% relative humidity. Although FDA does not require real-time stability data, the agency will occasionally request available long-term room temperature data on batches. "This is quite a drastic...change," Jerussi said. Since "getting the stability data together is often the rate limiting step on your submission of an abbreviated application," Jerussi said, "if we go to [submitting] six months worth of accelerated data, that means you get held up by another three months. If we want 12 months at room temperature that means you get held up by another nine months." Adopting the ICH standards, he concluded, "certainly would slow up the flow of submissions of generic drug applications." "In my opinion, there is no large problem with the stability of generic drugs," Jerussi stated. "FDA has not agreed with" the tripartite guideines. "There's been an awful lot of discussion going on within FDA." The stability requirements for new drugs under an April 1992 draft tripartite guideline are the same as are proposed for generic drugs, Jerussi noted. Jerussi added that the Pharmaceutical Manufacturers Association "apparently has accepted or is going to accept ICH's recommendations or suggestions on stability." FDA plans to publish that guideline. Jerussi suggested that generic firms may want to comment on it. ICH II is scheduled to take place Oct. 27-29 in Orlando, Fla. FDA recently released the report of its Task Force on International Harmonization ("The Pink Sheet" Jan. 25, p. 18). Jerussi also commented on the first draft of ICH's "guide to setting limits on impurities in new drug substances" dated November 1992. "The impurity guideline is talking about identifying and characterizing every impurity in a drug substance down to 0.1%," Jerussi said. There are "new drug substances, new molecular entities, new compositions of matter, [and] generic drug substances in the United States [that] are not treated that way right now," he observed. "That would be, in my opinion, a major, major, major change. I will also say in my opinion that I don't see any big problem with the purity of generic drug substances in the United States."

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