ICH guidelines and FDA guidelines

1. MUHAMMED SHARKY . M.Pharm
Department of Pharmacy Practice

2. 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.

3. 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”.

4.  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
those new drugs and medicines are developed in Western
Europe, Japan and the United States of America.

5.  The Observers are WHO, EFTA, 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.

6. ICH PARTIES
EURO
PEAN
COM
MISSI
ON/U
NION
EUROPEAN
FEDERATION
OF
PHARMACE
UTICAL
INDUSTRIES
AND
ASSOCIATIO
N
MINI
STRY
OF
HEAL
TH
LABO
UR
AND
WELF
ARE
JAPAN
PHARMACEUTI
CAL
MANUFACTUR
ER
ASSOCIATION
US
FOOD
AND
DRUG
ADMINI
STRATIO
N
PHARMA
CEUTICA
L
RESEARC
H AND
MANUFA
CTURER
S OF
AMERIC
A

7.  ICH Guidelines
 The ICH Topics are divided into four major categories and ICH Topic
are assigned according to these categories.

8. FOOD AND DRUG ADMINISTRATION

9. What Does the FDA Regulate?
 Food (with Agriculture Department)
 Drugs
 Biologics
 Medical Devices
 Cosmetics
 Anything That Produces Dangerous
Radiation
 25% of the Consumer Dollar

10. 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

11. 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

12. 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

13. 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

14. 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

15. OTC Drugs
 Labeling Is the Key
 Directions for Safe Use
 Recognize Complications
 Recognize Contraindications
 X-OTC Switch
 Why?
 When?

16. 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?

17. 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