ICH's mission to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration thereby reducing duplication of testing and reporting carried out during research and development of new medicines.
3. ICH- “international conference on harmonization”
ICH of technical requirements for registration of pharmaceutical for human use.
INTRODUCTION
4. ICH LOCATED
The Secretariat based in Geneva.
The biennial meetings and conference of the ICH sterring committee rotate between the EU,
Japan, USA.
OBJECT
• To increases ICH requirement to ensure safety, efficacy ,high quality
medicine develop.
OF
• To develop register pharmaceutical in the most efficient and cost
effective manner.
• To promote public health.
ICH
• To prevent unnecessary duplication of clinical trial on humans
• To harmonize technical requirement for registration or marketing
approval.
5. The ICH structure consist of the
ICH steering committee, ICH
coordinators, ICH secretariat
and ICH working groups.
Depending on the type of
harmonization activity needed,
the steering committee will
endorse the establishment of
one of the three type of working
group i.e. Expert working,
implementation working group
The body governs the ICH,
determines the policies and
procedure for ICH, select topics
for harmonization and monitors
the progress of harmonization
initiatives.
Are fundamental to the
smooth running of the ICH
and are nominated by each of
the six parties. An ICH
coordinators acts as the main
point with the ICH
secretariat,
Is primarily concerned with
preparation for, and
documentation of, meeting of
starring committee as well as
coordination of preparation for
working group and discussion
group meeting.
To discuss and establishment
common guidelines.
To promote a mutual
understanding of regional
initiatives in order to facilitate
harmonization processes
related to ICH guidelines
regionally and globally
6. STEPS IN THE ICH
• Draft are prepared and circulated through many revision until a “final
harmonized draft” is completed.
steps1
• Draft signed by EWG and forwarded to starring committee for signing which
signifies acceptance for consultation by each of six.
step2
• The three regulatory sponsor initiate their normal consultation process to
receive comment
step3
• The endorsement is based on signatures from the three regulatory parties to ICH
affirming that the guidelines is recommended for adoption by the regulatory
bodies of the three regions.
step4
• The guidelines are incorporated into national or regional intimal procedure.
step5
9. CARCINOGENICITY STUDIES(S1A-S1C)
S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceutical
To identify tumorigenic potential in animal
To assess the relevant risk in human
To avoid unnecessary use of animal in testing
Studies also preceded our current understanding of tumorigenesis with non-genotoxic
agent.
S1B(R2) : Testing for Carcinogenicity of Pharmaceuticals
This document provide guidance on the need to carry out carcinogenicity studies in both
mice and rats, and guidance is also given on testing procedure which may be applied .
10. S2 – GENOTOXICITY:
• S2(R2): Guidance on Genotoxicity Testing and Data Interpretation for
Pharmaceuticals Intended for Human Use
This guidance is a combination of ICH S2A and S2B guidelines
S2A : Guidance on Specific Aspects of Regulatory Genotoxicity Tests for
Pharmaceutical;
This document provided specific guidance and recommendation for in vito and in vivo test and
on the evaluation of test result. It include terms related to genotoxicity tests to improve
consistency in application.
11. S2b: A Standard Battery for Genotoxicity Testing for Pharmaceuticals:
This document addresses two fundamental areas of genotoxicity testing:
• The identification of a standard set of assays to be conducted for registration,
and the extent of confirmatory experimentation in any particular genotoxicity
assay in the standard battery.
• Registration of pharmaceuticals requires a compressive assessment of their
genotoxic potential. It is clear that no single test is capable of detecting all
relevant genotoxicity.
12. S3A- S3B: Toxicokinetic and pharmacokinetics
S3A: Note for Guidance on Toxicokinetic: The Assessment of Systemic
Exposure in Toxicity Studies
ICH guidelines do not require toxicokinetic studies to be conducted, except
in pregnant, lactating animals, before initiating reproductive studies
toxicokinetic is defined as the generation of pharmacokinetic data, either as
an integral component in the conduct of non-clinical toxicity studies or in
specially designed supportive studies, in order to assess systemic exposure.
13. S4: Duration of Chronic Toxicity Testing in Animals
The objective of this guidelines is to set out the consideration that apply to chronic toxicity
testing in rodent and non rodent as part of the safety evaluation of a medicinal product
• rodent(study duration 6 month )
• Non- rodent (a study duration nine month)
14. S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue
• Tissue distribution studies are essential in providing information on distribution and
accumulation of the compound ,metabolite ,especially in relation to potential sites of
action; this information may be useful for designing toxicity and pharmacology studies
for interpreting the result of these experiments.
• This document gives guidance, when the repeated dose tissue distribution studies
should be considered, it also give recommendation on the conduct of such studies
15. S5:Detection of Toxicity To Reproduction For Medicinal Product and
Toxicity To Male Fertility
• This document provides guidance on tests for reproductive
• It defines the period of treatment to be used in animals to better reflect human
exposure to medicinal product and allow more specific identification of stages at
risk
16. S6: Preclinical Safety Evolution of Biotechnology- Derived Pharmaceuticals
• This document covers the per- clinical safety testing requirement for biotechnology
products. It addresses the use of animal models of disease, determination of when
genotoxicity assays and carcinogenicity studies should be performed, and the impact of
antibody formation on duration of toxicology study.
17. S7A: Safety Pharmacology Studies for Human Pharmaceutical
This guidelines was developed to protect clinical trial participant and patients
receiving marketed product from potential adverse effect of pharmaceuticals
This document addresses the definition, objective and scope of pharmaceutical studies
18. S7B: The Non clinical Evaluation of The Potential for Delayed Ventricular
Repolarization By Human Pharmaceuticals
• Guideline describes a non-clinical testing strategy for assessing the potential of a test
substance to delay ventricular repolarization.
• This guidelines included information concerning non-clinical assays and integrated
risk assessment.
19. S8: immunotoxicity studies for human pharmaceuticals
• This guidelines addresses the recommendation on non clinical testing for
immunosuppressant
• The guidelines might also apply to drugs in which clinical signs of
immunosuppressant are observed during clinical trial and following approval to
market
20. S9: Nonclinical Evaluation For Anticancer Pharmaceutical
• This guidelines provides information for pharmaceutical that are only indented
to treat cancer in patients with late stage or advanced disease regardless of the
route of administration, including both small molecule and biotechnology-
derived pharmaceuticals.
• It describe the type and timing of nonclinical studies in relation to the
development of anticancer pharmaceuticals and reference other guidance as
appropriate.
21. S10: Guidelines-Photo Safety Evaluation of Pharmaceuticals
• These guidelines applies to new APIs .new excipient clinical formulation
for dermal application and photodynamic therapy product.
• In-vitro assay for photo-toxicity is the 3t3 neutral red uptake assay
• In vivo for species selection irradiation sensitivity, heat tolerance,
performance of reference substance should be considered.
22. S11: for non clinical safety testing in support of development of
podiatric medicines
• This guidelines is needed to recommended standard for the condition
under which non clinical juvenile animal testing is considered
informative and support paediatric trials.
23. REFERENCE
• “ICH OF TECHNICAL REQUIREMENT FOR REGISTRATION OF
PHARMACEUTICAL FOR HUMAN USE”, final concept Paper, endorsed By the
steering committee on 24May2001,
• “GUIDANCE ON GENOTOXICITY TESTING AND DATA INTERPRETATION
FOR PHARMACEUTICALS INTENDED FOR HUMAN USE”, current steps 4
version, dated: 9 November 2011.
• wwwIchslideshare
