Forum on Generic Drugs & Promise of Regulatory Science

1. Generic Drugs & Promise of Regulatory Science
(2/3)
Obaid Ali & Roohi B. Obaid
April 08th
, 2015
Hotel Regent Plaza, Karachi

2. All Praise be to
ALLAH

3. Session 3
Generic Drug Approval
Process
Obaid Ali, Roohi B. Obaid
Generic Drugs
Promise of Regulatory Science

4. Presentation Focus

5. Labeling (identical to RID)

6. Labeling (identical to RID)
Who will be responsible if any
adverse event or safety issue is
identified?
Innovator or Generic?

7. Labeling (identical to RID)
If innovator discontinued drug
due to any reason, and new ADR
appears
What will happen?

8. Labeling (identical to RID)
Is every generic holder responsible to
change label upon awareness of any
adverse drug reaction etc.?
While as a matter of fact, he never had
submitted the label but copied the
reference

9. Labeling (identical to RID)
If generic or innovator submits label
change regarding adverse drug
reaction experienced after its approval
then who will be the responsible for
delay in information to the public?
Regulatory Authority or the company

10. Labeling (identical to RID)
If the generic companies are allowed
or directed to incorporate ADRs
without permission of authority
Would it not confuse the patient and
healthcare provider?

11. Labeling (identical to RID)
Generic drug companies are required to
update the labels to reflect new and
emerging safety information
Let’s see where it goes but need to keep
ourselves align with the mission of public
safety

12. Bio-Pharmaceutical Evaluation

13. Bio-Pharmaceutical Evaluation

14. Bio-Pharmaceutical Evaluation

15. Bio-Pharmaceutical Evaluation

16. Chemistry, Manufacturing & Controls

17. Chemistry, Manufacturing & Controls

18. Chemistry, Manufacturing & Controls

19. Chemistry, Manufacturing & Controls

20. Chemistry, Manufacturing & Controls

21. Chemistry, Manufacturing & Controls

22. Chemistry, Manufacturing & Controls

23. Chemistry, Manufacturing & Controls

24. Chemistry, Manufacturing & Controls
PURITY

25. Chemistry, Manufacturing & Controls
PURITY

26. Chemistry, Manufacturing & Controls
QUALITY

27. Chemistry, Manufacturing & Controls

28. Chemistry, Manufacturing & Controls

29. Chemistry, Manufacturing & Controls
(US-FDA Perspective)

30. Chemistry, Manufacturing & Controls
(US-FDA Perspective)
Product quality and performance are achieved and assured by
design of effective and efficient manufacturing processes

31. Chemistry, Manufacturing & Controls
(US-FDA Perspective)
PRODUCT
PERFORMANCE

32. Chemistry, Manufacturing & Controls
(US-FDA Perspective)

33. Chemistry, Manufacturing & Controls
(US-FDA Perspective)

34. Chemistry, Manufacturing & Controls
(US-FDA Perspective)

35. Chemistry, Manufacturing & Controls
(US-FDA Perspective)

36. Plant Inspection: Intent of GMP

37. GMP Elements

38. GMP Systems

39. GMP: System Indicators & Attributes