International conference on Harmonization

1. Miss. Priyanka R. patil
M Pharm Ist year
Rajarambapu college of
Pharmacy ,Kasegaon
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2.  ICH is the “ International conference on
Harmonization of Technical Requirements for
Registration of Pharmaceuticals for human use ’’
 ICH is a joint initiative involving both regulators
and research based industry representatives of the
EU , Japan and US in scientific and technical
discussion of the testing procedure required to
assess and ensure the safety , quality and efficacy
of medicines.
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3.  More economical use of humans , animals
and material .
 Elimination of unnecessary delay in
availability of new medicine.
 Maintaining safeguard and protect health.
 To prevent unnecessary duplication of clinical
trials on humans.
 To minimize the use of animal testing .
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4.  To promote international harmonization by
bringing together representatives from the
three ICH regions ( EU , JAPAN ,USA )
 To discuss and establish common
guidelines.
 To make information available on ICH , ICH
activities and ICH guidelines to any country
or company that requests the information.
 To strengthen the capacity of drug
regulatory authorities and industry to utilize
them .
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5.  EU – European Union
 EUFPIA – European federation of
pharmaceutical Industry and Association
 MHLW – Ministry of Health Labor and Welfare
, Japan .
 JPMA – Japan Pharmaceutical Manufactories
Association.
 FDA –US Food And Drug Administration.
 PHRMA _ Pharmaceutical Research MFG of
America .
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6. 1.Steering Committee – Overseas the
harmonization activities. prepare policies
and procedure for ICH. Two seats on the
ICH steering committee.
2.Secretariat and Co-Ordinators – ICH
coordinators acts as the main contact point
with the ICH secretaries . Coordinators
nominated by each of the six parties. The
secretariate is primarily concerned with
preparation and doccumentation.
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7.  Each groups establishes a contact network of
experts within their own organization or
region in order to ensure that , in the
discussion they reflect the view and policies
of the co-sponcer they represent.
 ICH WORKING GROUPS….
1. EWG – Expert working group
2. IWG – Implementation working group
3. Informal Working Group
4. Discussion Group
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8.  ICH operates through the ICH steering
Committee with administrative support the
ICH secretariat and ICH coordinators.
 The steering committee meets at least twice a
year .During these meeting, new topic is
considered, report and implementation of the
guidelines are discussed.
 The topic Identified for harmonization by the
steering committee are selected from safety,
quality, efficacy and multidisciplinary matters.
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9. 1. Drafts are prepared and circulated through many
revision until a “ final harmonized draft ’’ is
completed .
2. This draft is signed by the EWG as the agreed
upon draft and forwarded to the steering
committee for signing which signifies acceptance
for consultation by each of the six co-sponsors .
3. The three regulatory sponsors initiate their
normal consultation process to receive
comments.
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10. 4. Is reached when the steering committee agree
that is sufficient scientific consensus on the
technical issues . This endorsement is based on the
signature from the Guideline is recommended for
adoption by the regulatory bodies of the three
regions.
5. The process is complete when the guidelines are
incorporated into national or regional internal
procedure .
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11.  QUALITY : Those relating to chemical and
pharmaceutical Quality Assurance .( Stability ,
Testing ,Impurity Testing )
 Efficacy : those relating to clinical studies in human
subject ( Dose Response studies , Good clinical
Practices )
 Safety : Those relating to in vitro and in vivo pre –
clinical studies (carcinogenicity Testing ,
Genotoxicity Testing etc )
 Multidisciplinary : Cross cutting topics which do
not fit uniquely into one of the above categories.
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THANK
YOU