INVESTIGATIONAL NEW DRUG&

NEW DRUG APPLICATION

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DRUG DEVELOPMENT

Development of a new therapeutic drug is a complex, lengthy andexpensive process

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expensive process

costs nearly huge amount andan average of 15 years.

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Introduction• Investigational new drug (IND)

It’s deals with a new chemical entity, which will be tested for obtaining evidence of safety and effectiveness in accordance with the regulations.

• New drug application (NDA)

Is a document submitted to the regulatory authorities for permission to market a new drug product in that country.

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Investigational new drug (IND)

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To assure the safety and rights of subjects in all phases of an investigation.

In phases 2 and 3, to help assure that the quality of the scientific evaluation of the drug

Objectives

quality of the scientific evaluation of the drug according to the -- (21 CFR 312.22).

• Code of Federal Regulations, part 312 (21 CFR part 312) (the IND regulations).

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TYPES OF IND Investigator IND

o Submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.

o Physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.

Emergency Use IND

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Emergency Use IND

o Allows FDA to authorize use of an experimental drug in an emergency situation .

o Does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.23 or Sec. 312.34

Treatment IND

o Submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

The IND application must contain :-

• In - vitro studies.

• Toxicology Studies.

• Chemical studies.

• Manufacturing Information .

• Clinical trail protocols.

• A review given by the institutional review board (IRB)

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Applicant\Drug Sponsor

IND

Review by CDER

Medicinal chemistry Pharmacological \ Toxicological statistical

Safety Review Sponsor submits new data

Safety acceptable for Chemical hold decisionNoSafety acceptable forstudy to proceed

Chemical hold decision

Complete reviews Notify Sponsor

Review complete & acceptable? Sponsor notified of deficiencies

No Deficiencies Study ongoing

No

No

NoYes

Yes

Yes

Investigational New Drug Application (IND)

10Investigational New Drug Application (IND) in INDIA

New drug application(NDA)

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(NDA)

Provide enough information to permit FDA reviewers to establish the following:

Safety & effectiveness of drug.

Benefits overweigh risks.

Risk Benefit

OBJECTIVES

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Is the drug’s proposed labelling (package insert) appropriate, and what should it contain?

Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?

NDA CONTENTS1. Introduction

Brief description of the drug and the therapeutic class to which it belongs

2. Chemical and pharmaceutical information

3. Animal Pharmacology

4. Animal Toxicology

5. Human/Clinical Pharmacology phase I

6. Therapeutic exploratory trials (Phase II)

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6. Therapeutic exploratory trials (Phase II)

7. Therapeutic confirmatory trials (Phase III)

8. Special Studies

o Geriatrics, pediatrics, pregnant or nursing women

9. Regulatory status in other countries

10. Prescribing information

11. Samples and Testing Protocol/s

When to get approval from NDA

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CLINICAL TRAIL PHASES

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Review of NDA process

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Requirements US INDIA

Application ANDA\NDA MAA

Debarment Classification

Required Required

Number ofcopies

3 1

Approval ~18 Months 12~18 Months

ADMINISTRATIVE REQUIREMENTSADMINISTRATIVE REQUIREMENTS

Approval Time period

~18 Months 12~18 Months

Fees Approximately$52,000 for

ANDA Application &

Up to $2 million for NDA Application

50,000 INR

Presentation eCTD & Paper Paper

Requirements US INDIA

Justification ICH Q6A ICHQ6A

Assay 90-100% 90-110%

Disintegration Not Required Required

Colour Identification Not Required Required

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Water Content Required Required

REFERENCES

21 CFR.org

www.Wikipedia.org

www.Cdsco.com

Drug regulatory affairs by thimasetty.Drug regulatory affairs by thimasetty.

http://www.fda.gov/

http://www.medicalnewstoday.com/artes/172522.php

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