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