Global submission of IND (Regulatory affairs).pptx

1
AL-AMEEN COLLEGE OF
PHARMACY
GLOBAL SUBMISSION OF IND
(INVESTIGATIONAL NEW DRUG)
NITHYAA SHRI S
MPHARM 1st YEAR
AL-AMEEN COLLEGE OF
PHARMACY
BENGALURU

2
CONTENTS
• INTRODUCTION
• PROCESS
• TYPES OF IND
• WHAT SHOULD BE THERE IN IND?
• FORMAT
• SUBMISSION TO U.S.
• SUBMISSION IN E.U.
• SUBMISSION IN INDIA

3
INTRODUCTION
• Investigational new drug is defined under 21CFR 312.3(b) as ''new drug
or biological drug that is used in clinical investigation.
• IND is submission to FDA or concerned regulatory body
by requesting permission to initiate the study of new drug products.
• IND is defined as the request from a clinical study sponsor to
obtain authorization from FDA to administer an IND or
biological product to human.

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PROCESS
1
• Sponsor – initiate and conduct investigation.
• After pre-clinical investigation - new molecule is identified
with pharmacological activity.
2
• The sponsor submits the application to FDA or particular regulatory body for
conduct of clinical trial.
Sponsor wait
for 30 days
Initiate clinical
trial
Identified that
the drug is
under legal
status
Become the
new drug
If the drug is
toxic – FDA or
concerned
regulatory body
of the country
to terminate the
clinical trial.

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TYPES OF IND'S
• Commercial IND: Application submitted by companies.
• Non-commercial IND :
1) Investigator's IND: It is submitted by a physician who initiated and
administers and dispenses the drug.
2) Emergency use IND: Human subject in a life-threatening situation in
which no standard acceptable treatment is available and in which there is
not sufficient time to obtain IRB approval for the use.
Submission of an IND in accordance with 21CFR sec 312.23

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• Treatment IND :Also called expanded access IND .
This IND is submitted for experimental drug showing promise. Clinical
testing of serious and life threatening conditions.
It is under 21 CFR 312.34.

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WHAT SHOULD BE THERE IN IND?
 Animal pharmacology and toxicology data
 Manufacuring information
 Clinical protocol and investigator information
MAIN
CONTENT
S

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FORMAT
1.COVER SHEET(1571): The cover letter is used for triaging and routing
of an IND application within FDA and is expected to include the following:
*Submission identifier
*Brief explanation of intended clinical use
*IND product's name and proposed formulation
*IND manufacturer's name and contact information
*Reference to an existing IND application

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TABLE OF CONTENTS
• The table of content for an IND application is expected to be detailed
to permit the FDA reviewers to locate the items in the application
quickly and easily
• Location of information is provided by volume and page .

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LETTER OF AUTHORIZATION
Letter of information consist of information contained in IND
application.
chemistry, manufacturing and control
information adequate to ensure the proper identification,
quality, purity and strength of the investigational drug.
Pharmacology and toxicology information.

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CLINICAL PROTOCOL
A CLINICAL PROTOCOL
FOR TREATMENT OF A
SINGLE PATIENT OR A
GROUP OF PATIENTS(I.E
INTERMEDIATE SIZE AND
LARGE SIZE PATIENT
POPULATION):
1)RATIONALE FOR THE
INTENDED USE OF THE
DRUG
2)DESCRIPTION OF
DISEASE OR CONDITION
3)PROPOSED METHOD OF
ADMINISTRATION OF
DRUG, DOSE, AND
DURATION OF THERAPY.
4)DESCRIPTION OF
CLINICAL PROCEDURES,
LABORATORY TESTS, OR
MONITORING NECESSARY
TO EVALUATE THE
EFFECTS OF DRUG AND
MINIMIZE ITS RISKS.

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INFORMED CONSENT : a copy of the informed consent for the investigational
treatment.
INVESTIGATOR'S BROCHURE: a copy of the investigator's brochure, if it was
not included in the materials granted for the reference in the letter of authorization.
STATEMENT ABOUT PRODUCT DEVELOPMENT: In addition to those above
information the investigational new drug should note whether the drug is developed or not
being developed.
Not developed - it should be justified
If the patients are not eligible for the investigational new drug, the sponsor has to explain
the reason that why they are not eligible.

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GLOBAL SUBMISSION OF IND
For marketing authorization application (MAA) a single
regulatory approach is applicable to various countries.
Different countries have different regulatory
requirements for approval of new drugs.

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SUBMISSION OF IND IN EUROPE
A clinical trial application (CTA) is filed to the competent authority of the state
to conduct the clinical trial within EUROPEAN UNION.
• The competent authority of that member state evaluates the application and
approves to conduct clinical trial.
• In the EU's countries, the company have a choice of following regulatory
Centralized Procedure, Decentralized Procedure, national procedure or
mutual recognition procedure.

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SUBMISSION OF IND IN INDIA

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• From the submission of IND to approval of clinical trial process – 30days.
• For the whole approval process i.e. approval for marketing of a drug -12 to 18
weeks
• Emergency IND - FDA and IRB reviews the IND within 5 days or
within hours (based on the emergency disease condition).

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• The Central Drugs Standard Control Organization (CDSCO), and the
office of its leader, the Drugs Controller General (India) [DCGI] were
established for review of IND application and conduct of clinical trials.
• When a company in India wants to manufacture/ import a new drug -
licensing authority (DCGI) - Form 44 also submitting the data as given
in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945

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• Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act 1940 and
Rules 1945 says for those drug substances which are discovered in India
all phases of clinical trials are required
• Section 2.4 (b) of Schedule Y of Drugs and Cosmetics Act 1940 and
Rules 1945 says that for those drug substances which are discovered in
countries other than India; the applicant should submit the data
available from other countries and the licensing authority may require
him to repeat all the studies or permit him to proceed from Phase III
clinical trials.

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REGULATORY DIFFERENCE
DCGI AND CDSCO
BSE- Bovine
spongiform
encephalopat
hy (BSE)
TSE-
transmissible
spongiform
encephalopat
hy (TSE).

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DIFFERENCE ADMINISTRATIVE
REQUIREMENTS

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MANUFACTURING AND CONTROL
REQUIREMENTS

3 0
REFERENCE
• https://www.fda.gov/drugs/investigational-new-drug-ind-appl
ication/ind-applications-clinical-treatment-contents-and-form
at
.
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5188860/
• https://www.researchgate.net/publication/367821003_GLOBA
L_SUBMISSION_ON_IND
• https://www.fda.gov/drugs/investigational-new-drug-ind-
application/ind-applications-clinical-investigations-

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