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Obaid Ali & Roohi B. ObaidCivil Services Officer at Drugs Regulatory Authority of Pakistan
Harmonization Creates Opportunities for Both Regulatory Professionals and Agencies in
Developing Countries
Roohi B. Obaid & Obaid AliCivil Service Officer
at Drug Regulatory Authority of Pakistan
Not the view of DRAP
Current judgment of speaker
No obligation on DRAP
Regulatory experience
It has nothing to do with any specific
commercial product
It is just a knowledge sharing
exercise nothing more than that
DISCLAI
MER
Can anyone assess the Safety
Efficacy & Quality of the drug by naked
eye ?
Opening Message
Visible, Sub-visible & invisible Challenges
Harmonization, Globalization & Standardization
Projects & Map of Opportunities
Closing Message
If you want to go fast, go aloneIf you want to go far, go together
About Half a billion population died
4 Lac per year in Europe
Recall the Retard Enemies and Sad Memories
Recall the Retard Enemies and Sad Memories
Small pox Plague Meningitis Tuberculosis
Heart Attack Infections Psychiatry Diabetes
Current Issues & Challenges
Hepatitis Ebola
Humans
Their systems
Their pain
SI
MILAR
Humans
Their systems
Their pain
SI
MILAR
Humans
Their systems
Their pain
SI
MILAR
Do disease has a boundary?
Quality Treatment ???
Every human deserves Quality Healthcare
Lets have a look at the back yard
Lets have a look at the back yard
Toxic solvent DEG
USA 1937
100s of deaths
An antibiotic
elixir
Lets have a look at the back yard
2008?
Lets have a look at the back yard
Over sulfated chondroitin sulfate (OSCS)
Lets have a look at the back yard
> 100 deaths
PIC Tragedy
Material Mix up
New
To
ols
Approaches
Stan
dard
sE
Q
P
S
REGULATORY
SCIENCE
Safety Efficacy Quality
D R U G
Pre Marketing Review Inspection Post Marketing
Evaluation
Challenges
The Regulatory World is highly complex
Science of Regulation
Innovation
Safety
Reas
onab
le
Bal
ance
Science of Regulation
Need justifies Outcome
Benefit Risk
Science has one language & speaks with logic
Lets enjoy benefits of science
Doctor
Driver
Technician
Manufacturing facility
PharmacistAll require a license to work/practice
Harmonization saves Resources
Harmoniz/sation Works
ICH
Japan
EU
ICH
USA
Observers: WHO & Canada
Balance is required between
Fast Access
Sovereign interest
Western Medicine
Economical Interest
Innovation
Safety
Globalization
Alternative Medicine
Social Interest
Stewardship
International Conference on Harmonization (ICH) Philosophy
Identification and elimination of the need to duplicate studies to meet different regulatory requirements
More efficient use of resources in the R&D process, as a consequence
Quicker access for patients to safe and effective new medicines
Standardized Data Elements
Controlled Vocabularies
Common Format
Outcomes
Speak same language
Quality, accuracy & consistency
Improve timeliness
CTD/eCTDreduces
delays and costs
Outcomes
Global Regulatory Initiatives
Joint Inspections
Joint investigations
Mutual Recognition
Data sharing
Memorandum of Understanding
APEC ASEAN GCC PANDRH SADC
A Bridge from ICH to the world beyond
Openness and Transparency
Regional Harmonization Initiatives
International Compatibility
Way to move forward
GlobalizationRegulatory burden
Innovation and Risk
Capacity and Capability
TI
ME
Error
Models of Projects (Example)
Brand Name Analysis
Sound and look alike……
Amaryl
Reminyl
Amaryl
Reminyl
Celebrex
Cerebyx
Celebrex
Cerebyx
Omacor
Amicar
Omacor
Amicar
Intelence (Etravirine) TabletsLetters in NameINTELENCE
Scripted may appear as
Spoken may be interpreted as
I e. L any voweln v, r, s, mt f, r, x de i, l any vowell b, e, hc a, r S
Look a like and sound alike letters
Relative Scale of Concerns
N
G
B
S E Q
S E Q
QES
Pre-Market Compliance Post-Market
G
B
N
SafetyEfficacyQuality
Equal voice
Consistency & Uniformity in decision
Question based Review & Critical Thinking
Organizational Approach
Learn, De-learn & Re-learn
Thanks
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