SUBMITTED BY

RESHMA FATHIMA.K

FIRST YEAR M.PHARM

DEPT OF PHARMACEUTICS

What is ICH?

ICH is a joint initiative involving both regulators and

research-based industry representatives of the EU, japan

and the US in scientific and technical discussions of the

testing procedures required to assess and ensure the

safety, quality and efficacy of medicines.

What does ICH stand for

The complete name of ICH is the “International

Conference on Harmonization of Technical

Requirements for Registration of Pharmaceuticals

for Human Use”.

Aim :

The International Conference on Harmonisation of

Technical Requirements for the Registration of

Pharmaceuticals for Human Use (ICH) was

established in 1990 as a joint regulatory/industry

project to improve, through harmonisation, the

efficiency of the process for developing and

registering new medicinal products in Europe,

Japan and the United States, in order to make these

products available to patients with a minimum of

delay.

ICH :

The International Conference on Harmonisation of

Technical Requirements for Registration of

Pharmaceuticals for Human Use (ICH) is a unique

project that brings together the regulatory

authorities of Europe, Japan and the United States

and experts from the pharmaceutical industry in the

three regions to discuss scientific and technical

aspects of product registration.

Purpose :

The objective of ICH is to increase international

harmonization of technical requirements to ensure

that safe, effective, and high quality medicines are

developed and registered in the most efficient and

cost effectivemanner

Objective :

The objective of such harmonisation is a more

economical use of human, animal and material

resources, and the elimination of unnecessary delay

in the global development and availability of new

medicines whilst maintaining safeguards on quality,

safety and efficacy, and regulatory obligations to

protect public health

Harmonising the technical content of the sections of

the reporting data where significant differences

have been identified between regulatory

requirements across the three regions: Europe,

Japan and the USA.

Steering Committee structure and participation :

The existing Steering Committee structure continues to be

appropriate. In the interests of greater transparency, the

Steering Committee, however, welcomes the appropriate

participation of other interested parties in a flexible and ad hoc

manner on topics which affect them.

Structure of ICH

ICH is a joint initiative involving both regulators and industry

as equal partners in the scientific and technical discussions

of the testing procedures which are required to ensure and

assess the safety, quality and efficacy of medicines.

The focus of ICH has been on the technical requirements for

medicinal products containing new drugs. The vast majority

of those new drugs and medicines are developed in Western

Europe, Japan and the United States of America.

The Observers are WHO, and Canada (represented by Health Canada).

This important group of non-voting members acts as a link between the

ICH and non-ICH countries and regions.

ICH is operated via the ICH Steering Committee, which is supported by

ICH Coordinators and the ICH Secretariat.

ICH PARTIES

EUROP

EAN

COMMI

SSION

/UNIO

N

EUROPEAN

FEDERATION

OF

PHARMACEU

TICAL

INDUSTRIES

AND

ASSOCIATION

MINIS

TRY

OF

HEAL

TH

LABO

UR

AND

WELF

ARE

JAPAN

PHARMACEUTIC

AL

MANUFACTURE

R ASSOCIATION

US FOOD

AND

DRUG

ADMINIS

TRATION

PHARMA

CEUTICA

L

RESEARC

H AND

MANUFAC

TURERS

OF

AMERICA

ICH Guidelines

The ICH Topics are divided into four major categories and ICH Topic Codes

are assigned according to these categories.

Stability

Q1A(R2) : Stability Testing of New Drug Substances and Products

Q1B : Stability Testing : Photostability Testing of New Drug

Substances and Products

Q1C : Stability Testing for New Dosage Forms

Q1D :Bracketing and Matrixing Designs for Stability Testing of

New Drug Substances and Products

Q1E : Evaluation of Stability Data

Q1F : Stability Data Package for Registration Applications in

Climatic Zones III and IV

Analytical Validation

Q2(R1) : New title: Validation of Analytical Procedures: Text and

Methodology

Previously: Text on Validation of Analytical

Procedures Validation of Analytical Procedures:

Methodology (in Q2(R1))

Q3A(R2) : Impurities in New Drug Substances

Q3B(R2) : Impurities in New Drug Products

Q3C(R3) : Impurities: Guideline for Residual Solvents

Pharmacopoeias

Q4 : Pharmacopoeias

Q4A : Pharmacopoeial Harmonisation

Quality of Biotechnological Products

Q5A(R1) : Viral Safety Evaluation of Biotechnology Products Derived

from Cell

Lines of Human or Animal Origin

Specifications

Q6A : Specifications : Test Procedures and Acceptance Criteria for

New Drug Substances and New Drug Products: Chemical Substances

(including Decision Trees)

Q6B : Specifications : Test Procedures and Acceptance Criteria for

Biotechnological/Biological Products

Good Manufacturing Practice

Q7A : Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Safety

Efficacy guidelines

Efficacy Topics

E3: Structure and Content of Clinical Study Reports

E4: Dose-Response Information to Support Drug Registration

E6: Good Clinical Practice : Consolidated Guideline

E8: General Considerations for Clinical Trials

E9: Statistical Principles for Clinical Trials

E10: Choice of Control Group and Related Issues in Clinical Trials

Multidisciplinary Guidelines

M1- MedDRA : Medical Terminology

M2- ESTRI : Electronic Standards for the Transfer of Regulatory

Information

M3- (R2) : Nonclinical Safety Studies for the Conduct of Human

Clinical Trials and Marketing Authorization for Pharmaceuticals

M4- CTD : The Common Technical Document

M5 : Data Elements and Standards for Drug Dictionaries

What Does the FDA Regulate?

Food (with Agriculture Department)

Drugs

Biologics

Medical Devices

Cosmetics

Anything That Produces Dangerous

Radiation

25% of the Consumer Dollar

Prescription Drug Regulation

Good Old Days

In the Early 1900s You Could Get Anything

You Wanted

No Concern for People Poisoning Themselves

Few Effective Drugs

Limited Rationale for Physician Supervision

Harrison Narcotics Act

Heroin Was the Hero Drug Because It Saved

People From Morphine

Getting a Drug Approved

Isolate or Synthesize the Agent

Many are Biologicals Cyclosporin

Tamoxifen

Structure Activity Design

Genetic Engineering

Do Animal or in Vitro Studies to Determine

Activity

Apply for an Investigational New Drug (Ind)

Permit

Clinical Trials

Phase I

What are the side effects?

Is it safe enough to test?

Phase II

Does it work at all?

What is the dosage range?

Phase III

Is it better than placebo?

Is it better than other treatments?

What are the side-effects

Conflicts in Clinical Trials

Life Saving Drugs

Patients want a cure

Drugs probably do not work

What if the drug is available outside the trial?

Do you quit a drug that works to get on the trial?

What if the patient Lies?

Non-Life Saving Drugs

Pay the subjects?

Docs get paid by the patient

Companies want positive results

Submit for FDA Approval

Clinical Trials Can Take Years

Very Expensive >>$100,000,000

Most Drugs are Not Approved

Labeling is Key to Approval

Narrow Use allows More Dangerous

Drugs

Broader Use Means More Money

Modern Labeling

Labeled for the Physician

Physician Chooses the Drug

Physician Is Assumed to Know

Pharmacology and Therapeutics

Must Provide All Information About

Side-effects and Contraindications

Huge Issue When States Allow Non-

physicians to Prescribe Drugs

Labeling and Promotion

Label Limited to Proven Efficacy

Until Recently, Promotions Limited to

Proven Efficacy

What Is the PDR?

Private Listing of Drug Info and

Promotions

Info Provided in the PDR in a Label

Must Be the Same As the Package Insert

OTC Drugs

Labeling Is the Key

Directions for Safe Use

Recognize Complications Recognize Contraindications

X-OTC Switch

Why?

When?

Controlled Substances

Drug Enforcement Administration (DEA)

What Are the 5 Schedules?

I High Potential for Abuse and No Currently Accepted Medical Use (in the Us) - Heroin

II High Potential for Abuse but a Medical Use

III Moderate Potential for Abuse

IV Low Potential for Abuse

V Lowest Potential for Abuse

Constitutional Right to Do Dope?

Post-Market Surveillance

Clinical Trials Are Limited in Time and Scope

Many Serious Side-effects Cannot be Detected in Trials

Dangerous to Include Pregnant Women, so no tetragons are detected

Docs are Supposed to Report Side-effects

Not always very effective

Large Scale Trials Should Continue

Who will fund them?

Drug Companies do not want to undermine their products