This document provides an overview of generic drugs and regulatory science. It discusses the historical background and challenges of innovator drugs. It also covers intellectual trade rights and generic drug evaluation, including patents, exclusivity, and data exclusivity. Additionally, it examines regulatory authorities and pharmaceutical regulations. Finally, the document discusses harmonization and joint working initiatives between regulatory authorities globally to standardized evaluation of generic drugs.

1. Generic Drugs & Promise of Regulatory Science
(1/3)
Obaid Ali & Roohi B. Obaid
April 08th
, 2015
Hotel Regent Plaza, Karachi

2. All Praise be to
ALLAH

3. Generic Drugs &
Promise of Regulatory Science
Thanks all of you for sparing time
&
Barrett Hodgson for today’s
arrangement

4. Session 1
Historical Background
Obaid Ali, Roohi B. Obaid
Generic Drugs &
Promise of Regulatory Science

5. Regulatory Science

7. Presentation Focus

8. Disclaimer
The views expressed in this
presentation are not necessarily
of the Drug Regulatory Authority
of Pakistan
It is an informal communication
that represents the best current
judgment and does not constitute
an advisory opinion or binding or
otherwise obligate or commit the
DRAP, to the views expressed.
This presentation is designed by
the speaker after consulting
international reference
documents

9. Challenges of Innovator Drugs

10. Risk Benefit Ratio
Need
Outcome
Justifies

11. Generic Drugs &
Regulatory Expectation

12. Intellectual Trade Rights &
Generic Evaluation
Patent & Exclusivity

13. Regulatory Authority
Trade and Commerce
Pharm
aceutical
regulations

14. Intellectual Trade Rights &
Generic Evaluation
Intellectual
property law
rewards
innovators by
providing
temporary
monopoly rights

15. Intellectual Trade Rights &
Generic Evaluation
Regulation and
laws about drug
registration etc.
ensures drugs
are of assured
safety, quality,
efficacy

16. Intellectual Trade Rights &
Generic Evaluation
Data Exclusivity
Clinical and pre-clinical
trial data of originator
company
These data receive
respect by protection
from regulatory
authority for a certain
length of time

17. Intellectual Trade Rights &
Generic Evaluation

18. Failures & Regulatory Emergence

19. Harmonization & Joint Working Initiatives
Globalization
Harmonization
I
C
H

20. Harmonization & Joint Working Initiatives
International
Generic
Drugs
Regulator
Pilot

21. Harmonization & Joint Working Initiatives

22. Harmonization & Joint Working Initiatives

23. Harmonization & Joint Working Initiatives
First Phase

24. Harmonization & Joint Working Initiatives
Second Phase

25. Integrity & Obligations
Sun
Cadila
Apotex,
India
Ipca
AgilaSpecialities
USV
Aarti
MarckBiosciences