Regulatory intelligence plays an important role in the pharmaceutical industry by helping companies stay compliant, influence regulations, and make strategic decisions. Key responsibilities of regulatory intelligence functions are to identify regulatory changes, conduct analyses to facilitate decision making, and serve as internal consultants. Having access to sources like regulatory authorities and trade associations helps with identifying opportunities, reducing costs and time to market, and increasing compliance. However, challenges include the large volume of information, regional differences, and unclear agency expectations that require regulatory professionals to "read between the lines".

1. REGULATORY INTELLIGENCE
– Role In Pharmaceutical
Industry
BY SHRUTI KARGUTKAR

2. INTRODUCTION
“Regulatory Intelligence is the act of
processing targeted information and data from
multiple sources, analyzing the data in its
relevant context and generating a meaningful
output.

3. Why Regulatory Intelligence?
- Pharmaceutical Industry Heavily Regulated
- Companies Operating Globally And Need To Be
Compliant
- Influence Future Regulatory Framework

4. Key responsibility of RI function
Identify and communicate significant changes in the regulatory
environment
Conduct and deliver analyses that facilitate strategic decision-making
Serve as internal regulatory consultants and respond to adhoc
intelligence requests
Facilitate access to high-value regulatory intelligence sources
Enable effective advocacy work

5. Sources and resources-

6. Benefits of RI activities
Identifying regulatory opportunities
Reduced time to market
Reduced development costs
Increased compliance

8. Challenges for RI professional include
Ever increasing growth of information
Regulatory Authority transparency initiatives
Regional differences
Information flow

9. COMPONENTS OF REGULATORY
INTELLIGENCE
1. COMPETITOR INFORMATION
2. REGULATORY ENVIRONMENT
3. LEGAL REQUIREMENTS
4. REGULATORY STRATEGY

10. BENEFITS
1. Identifying regulatory opportunities
2. Reduced time to market
3. Reduced development costs
4. Increased compliance

11. COMPETITOR INFORMATION
Status Of Competitive Drug –
1. Pre-clinical
2. Clinical
3. Launched
4. Where Launched
5. Post-approval Commitments

12. Regulatory Environment
 Agency Benchmarks
 Regulatory Guidance Documents & Changes
 Trade Associations
 Regulatory Associations (ICH & WHO)

13. Legal Environment
 General requirements
 Specific Populations
 Orphan drug designation

15. “RI PROFESSIONALS OFTEN HAVE TO READ BETWEEN THE LINES,
BECAUSE AGENCY’S EXPECTATIONS AND REQUIREMENTS ARE
NOT ALWAYS CLEAR”
-GARY BUEHLER
VP OF GLOBAL REGULATORY INTELLIGENCE
TEVA PHARMA

16. Going Beyond Traditional Outsourcing Services
Even though companies have started opting for regulatory
outsourcing partners, the trends in services dynamically change
every now and then. The year 2013-2014 witnessed a
commendable growth of more than 40% in just the regulatory
publishing and writing services out of the entire regulatory
outsourcing market. However earlier the main focus persisted
the functional tasks such as dossier management and
& submissions, now we see new doors unlocked for companies
for new regulatory undertakings like Regulatory Intelligence,
CMC and labelling and regulatory data management

17. REFERENCES
1. Why Regulatory Intelligence Is More Important
Than Ever- By Cathy Yarbrough
2. European Industrial Pharmacists Group –Guide to
Good Regulatory Practice
3. www.europeanregulatory.com/regulatory-
intelligence/
4. TOPRA
5. “The company regulatory intelligence (RI)
function”The Regulatory Affairs Journal-pharma”,
October 2007

18. Thank You

19. Questions?