ICH, Globalization & Drive of

Pharmaceutical Regulatory Sciences

Dr. Obaid AliCivil Service Officer, Member, ISPE, PDA

26 March 2017

Not the view of DRAP

Current judgment

No obligation on DRAP

Regulatory experience

D

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References US-FDA WHO ICH NRAs

Lets think

What will happen if Pharmaceutical Industry does

not exist or stop working in world?

Who Cares?

It is Pharmaceutical Industry … Science … Research ..

Safe, efficacious & have correct identity

Deliver the same performance as claimed

Perform consistently over shelf life

Made in a manner that ensure quality

Will be available when needed

Patient and

Doctor

assume that

Drugs are

Lets think

What will happen if Pharmaceutical Industry is not

regulated in the world?

Typically Consumer Can not

see Quality

Safety Efficacy Quality

Pre Market

Manufacturing & Supply

Post Market

Translational Science

Constitution Act Regulations

Policies Initiatives

Innovation

Science

Need justifies Outcome

RiskBenefit

Science of Regulation

Judge

Efficacy

Performance

Quality

Safety

Tools

ApproachesStandards

Emerging Science & Innovation

Increasing Disease Burden

Expanding Regulatory Complexity

Globalization

Harmonization

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Harmoniz/sation Works

USA

JapanEU

Members Observers

WHOHealth Canada

Unique ApproachInternational Conference on Harmonization (ICH) was created in 1990

Agreement between the EU, Japan and the USA to harmonize different regional requirements for registration of pharmaceutical drug products

Unique because joint effort by regulators and associated pharmaceutical industry trade associations

ICH PhilosophyIdentification 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

Lets align and keep it clear …. that ICH

is neither a forum of global politics nor a trade negotiation, but a scientific forum

mainly covers “new drugs”

guidelines provide “how to collect data scientifically for marketing

authorization”

Step by Step Moving Approach

Regulatory Implementation

Adoption of GL by Regulators/Publishing ICH GL

Regulatory Consultation/Consolidation of Comments

SC Agrees to Releasing Draft GL

Consensus Building/Drafting of GL

Working Groups

Safety Efficacy Quality Multidisciplinary

Steering Committee

Endorses topics, guidelines, and monitors progress

The way leading Agencies work

1

• Amending Existing GLs

2

• Issuing New GLs

3

• Law Amendment

Formal Vehicles

Q&A Seminars Publications Etc.

Implementation Process Flow

Topic Selection

Dissemination

Publication

Training

Implementation

Management

Good guideline topic

selection

Formal communication

process

Active distribution

Educating users

Putting guideline „theory‟

into „practice‟

Active monitoring

of utilization

Guideline must be value-

added and ‘implementable’

Use multiple avenues

Targeted; via meetings;

also to non-ICH groups

‘Early, often, all’; within and

across organizations

Integrated process; address

questions/issues

Feedback to ICH SC

Implementation StepProcess Actions

A „mature‟ harmonization initiative

A series of technical guidelines emerging, a dictionary of medical terms, electronic standards and a common format

Multiple ICH conferences

Witnessing increased interest in and use of ICH guidelines globally

Formation and evolution of Global Cooperation Group (GCG)

ICH

Today

Q1 …

Q12

Q

S1 …

S11

S

E1 …

E18

E

M1 … M8

M

ICH

Today

Following over a

decade of significant

achievements in the

harmonization of Q,

S, E requirements for

the registration of

new drugs in the

three ICH regions,

Is the work of

ICH mostly done?

Will ICH become a maintenance-only

organization?

Proper balance b/w maintenance and new activities

New topics of high value & objectives are achievable

Most efficient use and management of resources

Flexible enough to deal evolving science/technologies ….. More transparent

Appropriate time to evaluate the future of ICH to ensure:

NO

Tangible Outcomes

Standardized Data Elements

Controlled Vocabularies

Common Format

Tangible Outcomes S

pea

k s

ame

languag

e

Qual

ity,

acc

ura

cy

& c

onsi

sten

cy

Impro

ve

tim

elin

ess

CT

D/e

CT

Dre

duce

s del

ays

and c

ost

s

Opening new Horizons continued• Review

Current Practice at regional and ICH level

• Options

Strengthen transparency and communication

• GCG

Communication & engagement with non-ICH regions & parties

Global Cooperation Group

Established March 1999 as sub-committee of ICH Steering Committee

Formed to respond to this growing interest in ICH guidelines

Name reflective of desire to establish links with non-ICH regions

Info

rmat

ion S

har

ing

Join

t M

eeti

ngs

Regional Harmonization Initiatives

APEC ASEAN GCC PANDRH SADC

A Bridge from ICH to the world beyond

Openness and Transparency

Yesterday Dream is a Reality Today

Moving beyond bounds of ICH

Serve as unique forum for harmonization

initiatives to discuss

Best practices

Lessons learned

Innovative approaches to harmonization and

regulation

Road where traffic is moving ahead

ICH technical guidelines

Harmonization/regulation

Training and capacity building

There is no harm to have a Dream

One world

One patient

One drugOne

quality

One time

Harmonization & Joint Working Initiatives

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Collaboration ConvergenceRegulatory Mandate

Increased work load

Globalization Scientific

complexity

Mutual Reliance

Work sharing

Efficient use of

Resource

Faster review

Greater availability

Generics

Harmonization & Joint Working Initiatives

P

I

C

S

PIC 1970

PIC/S 1995

Re-organized in Jan 2014

Membership of

Pharmaceutical Inspection Co-operation Scheme

(PIC/S)

A gate way towards best protection and promotion of

public health and Pharmaceutical industries

Purpose

Cooperation …mutual

confidence

Exchange of information &

experience

Mutual training & Technical Expertise

Improvement & Harmonization

Continuity of common efforts for

GMP

Equivalent standard for global

harmonization

Closing Message

We can be blind to the obvious, and we are

also blind to our blindnessDaniel Kahneman