Presentation on ICH guidelines.

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3. OBJECTIVES
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4. STRUCTURE
OF ICH

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The Steps in ICH Process
1 2 3 4 5

6. Guidelines
QUALITY SAFETY
EFFICACY
MULTI-
DISCIPLINARY

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QUALITY

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12. SAFETY
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EFFICACY

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M1: Medical Terminology
It provides an international medical dictionary
applicable to all phase of Product Development.
M2: Electronic Standards for
Transmission of Regulatory
Information (ESTRI)
It facilitates international electronic
communication by evaluating and recommending
the specifications.
MULTIDISCIPLINARY

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M3(R2): Guidance on Non-Clinical
Safety Studies for the Conduct of
Human Clinical Trials and
Marketing Authorization for
Pharmaceuticals
M4: The Common Technical
Document
It provides a harmonized structure for new product
applications
M5: Data Elements and Standards
for Drug Dictionaries

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