Thousands of Regulatory Professionals targeted for this global benchmark in Pharmaceutical regulatory trends
Philadelphia, Pennsylvania, USA - June 13th, 2005 - Thomson Scientific & Healthcare, the global leader in providing regulatory
software solutions, information products and related services for the life sciences
industry, today unveiled the early findings of its 2005 Liquent Regulatory Affairs
Trends Survey. This annual survey, which is now in its third year, provides
insights and perspective into how regulatory departments use technology and
how they plan to harness technology in the future. Thousands of regulatory professionals
were targeted to gather input for what is today recognized as the premier benchmark
of global regulatory submissions trends. Thomson Scientific & Healthcare
is part of The Thomson Corporation (NYSE: TOC; TSX: TOC).
Regulatory Affairs departments ensure the appropriate licensing, marketing
& legal compliance of pharmaceutical and medical products and have become
of pivotal significance to the successful development and bringing to market
of new products. The 2005 survey yielded responses from Europe and North America
with over half its respondents from the US and the majority of the remaining
from Europe, specifically the UK, France and Germany. The 117 respondents represent
large, medium and small pharmaceutical companies and a third of respondents
came from medical devices and biotechnology companies. The study concentrates
on four key areas; Technology Usage Trends, including both submission publishing
software and other desktop software, Document Management System usage, Regulatory
Outsourcing trends, and Regulatory trends including use or future use of the
electronic Common Technical Document (eCTD). This year’s survey also addressed
the broader regulatory product management needs including registration management,
submission project management and product information management both today
and in the future.
Survey highlights include:
Technology Usage
- Almost all (92%) of the survey respondents make regulatory submissions,
and three-quarters (76%) of them stated that they will still be using both
paper and electronic forms of submission in two years.
- Interestingly only 2% of respondents are addressing the SAFE initiative
and almost three-quarters (71%) don’t know whether or not they will
implement the process.
- 70% of respondents use a document management system compared with only
50% in 2004
Regulatory Trends
- Three-quarters (76%) of respondents plan to migrate to the eCTD which compares
to 58% in the 2004 survey; one-third (32%) of these respondents plan to migrate
within 10-18 months compared with 26% in 2004
- A majority of respondents (69%) are aware of the recent changes to 21 CFR
Part 11 in 2004, but just one-third (33%) felt that the changes were only
somewhat clearly communicated.
Jim Nichols is Liquent’s Vice President of Product Strategy and Marketing
and spearheaded this worldwide initiative, “We are delighted with the
response that we have received from pharmaceutical, biotechnology and medical
devices companies who have taken the time to respond to our survey and provide
such valuable insight into how their regulatory departments use, and plan to
use, technology. We also welcome the extensive interest that we have received
from publishers and conference organisers and we look forward to releasing the
full results in the next few days.”
For more information on the survey, its findings and how to secure a copy,
please contact info@liquent.com.
About Liquent regulatory solutions
Liquent regulatory solutions provides software, information products,
and related services for the life sciences industry. These solutions and services
help ensure clients meet the strict standards of regulatory authorities across
the world helping them achieve quality, accuracy, and data integrity to deliver
regulatory reports and submissions reliably and on time. In addition to technology
and services, the Liquent IDRAC database service provides the most comprehensive
intelligence on the drug and biologics regulatory environment in 38 of the largest
markets in the world.
As a result, 48 of the top 50 global life sciences companies rely on Liquent
regulatory solutions to stay current with the latest intelligence and to provide
the technology and services to compress the regulatory submissions and approval
process, improving speed to market, cost control, and productivity, all of which
contribute to ensuring patients’ and physicians’ timely access to
new drugs. Over the last decade, more than 5,000 regulatory submissions have
been produced using Liquent world-class products and expert services. For more
information please visit, www.liquent.com.
