DRUG COMPANIES EMBRACING ECTD SUBMISSIONS, SURVEY SAYS

Three-quarters of the regulatory professionals polled in a recent survey expect to implement electronic common technical document (eCTD) submissions, up from 58 percent last year. Nearly one-third (32 percent) of those respondents plan to migrate to eCTDs within 10 months to 18 months, compared with 26 percent in 2004, according to preliminary data from the survey.

However, 76 percent of those surveyed expect to be making both paper and electronic regulatory submissions in two years, said Thomson Scientific & Healthcare, a Stamford, Conn.-based provider of regulatory software and services, which conducted the 2005 Liquent Regulatory Affairs Trends Survey. Liquent, based in Horsham, Penn., is a division of Thomson.

The 117 respondents represent a variety of pharmaceutical companies in Europe and North America; more than half are from the U.S. One-third of those polled work for medical device and biotechnology companies.

According to the poll, use of document management systems by drugmakers is increasing, from 50 percent in 2004 to 70 percent this year.