Rashid Mureed presented on emerging trends in regulatory compliance in the pharmaceutical industry. He discussed the shifting regulatory paradigm from quality control to ensuring safety, efficacy, and quality manufacturing processes. He also touched on issues like patent cliffs, increasing drug development costs, generic industry regulations, and ongoing problems like compounding center outbreaks. Mureed concluded by noting the need to discuss medical innovation and access together, signs that the current business model is exhausted, and future trends around risk-based inspections and harmonization.

1. Rashid Mureed
Head of Regulatory Affairs: OBS Group
(MSD Pakistan/OBS Pakistan/AGP & Aspin Pharma)
Emerging Trends Of Regulatory Compliance
In Pharma Industry
PharmAcist House, Karachi Pakistan dated 20th
Aug-17

2. Presentation Highlights
ConfidentialEmerging Trends Of Regulatory Compliance
• Shifting Regulatory Paradigm• Shifting Regulatory ParadigmParadig
m
Wednesday, August 23, 2017

3. ConfidentialWednesday, August 23, 2017
Introduction
Emerging Trends Of Regulatory Compliance

4. Confidential
Generics versus Big Pharma
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

5. Confidential
Top 25 Global Generic Companies
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

6. India’s First Compulsory License
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7. 1st Patent dismissed for timing
ConfidentialEmerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

8. Annual compensation packages of top 5 CEOs in
pharmaceutical industry
1 J&J William Weldon 2011 US$ 26.7 million
2 Pfizer Ian Read 2011 US$ 25 million
3 Abbott Miles White 2011 US$ 24 million
4 Mylan Robert Coury 2011 US$ 21.3 million
5 Amgen Kevin Sharer 2011 US$ 18.9 million
Executive compensation
Emerging Trends Of Regulatory Compliance ConfidentialWednesday, August 23, 2017

9. Regulators Perception
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Medicines is a very special category of products „ Consumers, patients and
(even) health care workers have limited capacity to judge there:
S A F E T Y
Q U A L I T Y
E F F I C A C Y „
And all these have to built in ONE – the medicine
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

10. How medicines industry regulation compares
with other well regulated industries?
 Pharma industries and their products likely the most regulated
industries/products, but … perhaps aircraft industry regulations have achieved
globally better results
 Most journeys by air from A to B are very effective and safe (very high %
starting the journey reaches from A to B, almost all getting in air land safely as
well) „
 If the aircraft business would be globally regulated as good or bad as
medicines today
 Perhaps quite high % of planes would not take off the ground or would not
reach the destination for quality reasons
 Not talk about the inherent relative lack of efficacy of many medicines
In case of medicines it is not rare that from 100 starting the journey (treatment)
only less than 10 may reach the destination (cure)
Emerging Trends Of Regulatory Compliance ConfidentialWednesday, August 23, 2017

11. Confidential
Patent cliffs
Exploding costs of drug discovery and development
Much higher hurdles for approval for major indications
Blockbuster strategy is dead
Niche markets
Orphan indications
High failure rate – have to cover cost of failures in pricing of successful drugs
Generic competition
Big Pharma moving more toward Development and away from Discovery
Emerging Issues and challenges
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

12. Emerging Issues and challenges
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Scientific
Regulatory
Marketing
Legal
Healthcare
Professional
Patient
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

13. Confidential
Emerging Issues and challenges
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

14. Pharmaceutical Marketing Mix
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15. Confidential
Harmonization of regulatory requirements
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

16. Harmonization of regulatory requirements
Emerging Trends Of Regulatory Compliance ConfidentialWednesday, August 23, 2017

17. Confidential
Generic Industry Regulatory Compliances
ICH Q8ICH Q8
ICH Q9ICH Q9
ICH Q10
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

18. Confidential
GxP-360
Unannounced
Inspections
Generic Industry Regulatory Compliances
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

19. Shifting Regulatory Paradigm
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 From elementary quality requirements to safety and efficacy
 From quality control of finished product to quality of manufacturing
 From quality control of finished products and inspection of
manufacturing sites in general to more understanding the processes
and product specific process involved.
 From rigid limits to agreed upon before hand set of limits which can be
used by manufacturer in a more flexible manner
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

20. Shifting Regulatory Paradigm
Emerging Trends Of Regulatory Compliance ConfidentialWednesday, August 23, 2017

21. Confidential
Shifting Regulatory Paradigm
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

22. Confidential
• New England Compounding Center
meningitis outbreak 2012
Shifting Regulatory Paradigm
Emerging Trends Of Regulatory ComplianceWednesday, August 23, 2017

23. Old problems continue
Emerging Trends Of Regulatory Compliance ConfidentialWednesday, August 23, 2017

24. 2017 Trends-General
Emerging Trends Of Regulatory Compliance ConfidentialWednesday, August 23, 2017

25. Confidential
Emerging Trends Of Regulatory
Compliance
Conclusions
 Medical innovation cannot be discussed today without discussion on
access.
 Last 200 years of medical innovation have been more productive than
rest of the recorded human history.
 Current business model is showing signs of exhaustion
 Era of innovation for innovation.
 Risk based Inspections
 Harmonization's
 New diseases
Wednesday, August 23, 2017

26. THANKS!
ConfidentialEmerging Trends Of Regulatory Compliance
Rashid Mureed
Pharm-D/MBA/LLB
rashid.mureed@obs.com.pk
Wednesday, August 23, 2017