Pharma Regulatory Affairs Groups Are Placing Greater Importance on Regulatory Intelligence
54% of drug companies find successful regulatory intelligence to be extremely important to policy planning
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Recent Cutting Edge Information data revealed a trend in regulatory affairs teams using regulatory intelligence to align company policies with current biopharmaceutical regulations.
“Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges”
Regulatory intelligence has become a pivotal aspect of the regulatory affairs function. Regulatory personnel constantly seek out, analyze and communicate information about new guidances and requirements emerging from different markets. The goal of regulatory intelligence is to keep companies updated on the regulatory environment so that policies and product decisions align with all relevant agencies. Furthermore, regulatory intelligence analyzes new regulations to see how companies may need to change to meet new requirements.
The newly launched study, “Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges,” surveyed and interviewed regulatory affairs executives. They reported that successful regulatory intelligence is either important (46% of respondents) or extremely important (54%). Among global groups, 33% believe that regulatory intelligence is extremely important. The results are even higher for country-level regulatory teams. Seventy-one percent of surveyed country-level groups rate regulatory intelligence as extremely important.
“Most regulatory changes occur within countries, so ground-level regulatory intelligence can keep local teams up-to-date on regulations that may not be as important at the global level,” said Jacob Presson, research analyst at Cutting Edge Information. “As a result, regulatory intelligence may have greater influence at the country level than at the global one.” Nevertheless, global teams have to align their product development with every regulatory environment in which they plan to market their products. Because of this requirement, regulatory intelligence is important to all surveyed teams regardless of company level.
The study “Pharmaceutical Regulatory Affairs: Arming Regulatory Groups with Voice and Influence to Meet Strategic Challenges,” (http://www.cuttingedgeinfo.com/research/regulatory/pharmaceutical-regulatory-affairs/) provides benchmarks and best practices for expanding regulatory affairs’ strategic impact. Backed by quantitative and qualitative research, this study examines regulatory groups’ roles and responsibilities internally and externally. Data include how often regulatory affairs groups meet with internal clients and maintain communication with regulatory agencies.
Use this report to:
- Increase cross-functional communication
- Redefine regulatory affairs teams’ roles
- Strengthen relationships with regulatory agencies
- Improve regulatory spending and activities
For more information about regulatory affairs benchmarks, contact Cassie Demeter at 919-403-6583.