By Kim Coghill
Washington Editor
WASHINGTON The FDA and regulatory organizations in Europe and Japan recently made it easier for companies to submit new drug applications by accepting a common set of guidelines for filing.
As a result, companies no longer will be forced to reformat drug applications for each of the three regulatory groups. This move follows the July implementation of the common technical document (CTD) developed by the International Conference of Harmonization (ICH). Aside from the FDA, other members of the conference are the Washington-based Pharmaceutical Researchers and Manufacturers of America (PhRMA); the European Commission; the European Federation of Pharmaceutical Industries and Associations in Brussels; the Ministry of Health, Labor and Welfare in Japan; and the Japan Pharmaceutical Manufacturers Association.
The CTD is a common format for technical information that is required as part of submission for approval in the U.S., Europe and Japan. Using the CTD, companies will be able to file applications simultaneously in each country.
The regulatory organizations will accept CTDs on a voluntary basis until 2003, at which time CTDs will become mandatory in both Japan and Europe. Because of its lengthy rulemaking approval process, in 2003 the FDA will only strongly recommend use of CTDs.
Caroline Loew, PhRMAs assistant vice president for international regulatory affairs, said it likely will take the FDA until 2005 to mandate CTDs, when both the paper and electronic versions have been finalized and approved.
For a lot of biotech companies this might seem like a significant up-front investment to be using the common technical document, Loew told BioWorld Today. Companies will have to invest a lot of time and effort into understanding how they are going to work with it. I think for a lot of smaller biotechs theres some hesitancy about moving to this. The reality is, from our perspective, there will be significant savings in the longer term for these companies as they compile dossiers. These companies need to think about doing this because it will become mandatory and the sooner they get on board, the sooner they can reap the rewards.
Biogen Inc., of Cambridge, Mass., is one of the first biotechnology companies to file a CTD. In early August, the company used a CTD for its drug application for Amevive, a treatment for moderate to severe chronic plaque psoriasis. (See BioWorld Today, Aug. 7, 2001.)
Kathryn Bloom, Biogens senior director of public affairs, told BioWorld Today that the CTD filing process is extremely sophisticated and at this point, she doesnt believe theres any way to determine just exactly how much money or time the CTD will save. But, she said, We filed an electronic document so it makes it easier for the reviewers, who usually get volumes of documents.
Loew said studies have been done that indicate CTDs will represent a significant cost savings to companies. There was a study showing that it takes a company between two and six months to reformat from the U.S. to European [standards]. This puts it in the same format so you can just fire it off to the different agencies. Companies will be able to get through the approval process more quickly and drugs will get to the patients more quickly.
The concept of the CTD was born out of the July 1997 meeting of the ICHs steering committee, which determined that regulatory systems are based on the same fundamental obligations of evaluating quality, safety and efficacy. During the years, the drug companies have been forced to duplicate many time-consuming expensive test procedures in order to market products in different countries. The rising cost of health care along with the publics desire for drugs and the amount of money invested in research and development prompted approval of these common guidelines.