This document summarizes a presentation on Investigational Medicinal Product Dossier (IMPD) and Investigation Brochure (IB). The presentation covered: 1. An introduction to IMPD, including that it is submitted to the European Union for clinical trial authorization and contains quality, nonclinical, and clinical data. Two types of IMPDs were described - full and simplified. 2. An introduction to the IB, which compiles relevant clinical and nonclinical data on investigational products to inform investigators. Key contents of an IB like title page, summary, and clinical data sections were outlined. 3. The differences between IMPD and IB, with IMPD focusing more on nonclinical development data and IB

1. PRESENTATION
ON
“INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER”
&
“INVESTIGATION BROCHURE”
PRESENTED BY:
ANURAG PANDEY
M.PHARM
(17MPH101)
DEPARTMENT OF PHARMACEUTICS
INSTITUTE OF PHARMACY,
NIRMA UNIVERISTY, AHEMDABAD
UNDER THE GUIDANCE OF:
MRS. TEJAL MEHTA
PROFESSOR & HOD
OF
DEPARTMENT OF PHARMACEUTICS
INSTITUTE OF PHARMACY,
NIRMA UNIVERISTY, AHEMDABAD

2. PRESENTATION CONTENT
1. INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD)
A- INTRODUCTION
B- TYPES OF IMPD WITH IT’S CONTENT
2. INVESTIGATION BROCHURE (IB)
A- INTRODUCTION
B- TABLE OF CONTENT OF IB
3- DIFFERENCE BETWEEN IMPD & IB
4- PROCEDURE FOR CONDUCTING CLINICAL TRIALS WITH
COMPARISON BETWEEN USFDA & EUROPEAN UNION
A- DIFFERENCE BETWEEN USFDA & EUROPEAN UNION FILING FOR
CLINICAL TRAILS
B- HOW TO FILE IN BOTH WITH COMAPARISON

3. 1-INVESTIGATIONALMEDICINAL PRODUCTDOSSIER (IMPD)
A. INTRODUCTION
SOURCE :- EUROPEAN UNION WEBSITE

4. CONT..
 Before human clinical trials can be started in the European Union (EU), the
sponsor must request authorization to conduct clinical trials through a
submission called a Clinical Trial Authorisation (CTA). This application
includes a group of scientific documents called an Investigational Medicinal
Products Dossier (IMPD).
BRIEF ABOUT IMPD ANY QUERIES?
SOURCE :- EUROPEAN UNION WEBSITE

5. CONT..
B. TYPES OF IMPD WITH IT’S CONTENT
 The EU has provided for two types of IMPDs, a “full IMPD” and a “Simplified
IMPD”, based on whether the product has been described previously in another
CTA or a marketing authorization application
 Guidance on the structure and content of an IMPD is provided by the European
Commission (EC) in ENTR/F2/BL D(2003) CT1 Revision 2, dated October 2005.
The IMPD consists of a group of documents, with cross-references to other
documents, such as the investigator’s brochure, the clinical protocol, or another
IMPD.
 The IMPD has a general structure:
 Quality (chemistry, manufacturing, and controls) data
 Nonclinical pharmacology and toxicology data
 Previous clinical trial and human experience data
 Overall risk and benefit assessment
SOURCE :- EUROPEAN UNION WEBSITE

6. CONT..
“FULL IMPD”
SOURCE :- EUROPEAN UNION WEBSITE

7. CONT..
“FULL IMPD”
SOURCE :- EUROPEAN UNION WEBSITE

8. CONT..
“SIMPLIFIED IMPD”
SOURCE :- EUROPEAN UNION WEBSITE

9. CONT..
“SIMPLIFIED IMPD”
SOURCE :- EUROPEAN UNION WEBSITE

10. INVESTIGATION BROCHURE
A- INTRODUCTION
1. It is a compilation of the clinical and nonclinical data on the investigational
product(s) that are relevant to the study of the product(s) in human subjects.
2. Its purpose is to provide the investigators and others involved in the trial with the
information to facilitate their understanding of the rationale for, and their
compliance with, many key features of the protocol, such as the dose, dose
frequency/interval, methods of administration: and safety monitoring procedures.
3. The information should be presented in a concise, simple, objective, balanced, and
non-promotional form that enables a clinician, or potential investigator, to
understand it and make his/her own unbiased risk-benefit assessment of the
appropriateness of the proposed trial.
4. The IB should be reviewed at least annually and revised as necessary in compliance
with a sponsor’s written procedures.
SOURCE :- ICH GCP - INVESTIGATION BROCHURE.PDF

11. CONT…
5. Generally, the sponsor is responsible for ensuring that an up-to-date IB is made
available to the investigator(s) and the investigators are responsible for providing the
up-to-date IB to the responsible IRBs/IECs.
6. In the case of an investigator sponsored trial, the sponsor-investigator should
determine whether a brochure is available from the commercial manufacturer.
7. If the investigational product is provided by the sponsor-investigator, then he or
she should provide the necessary information to the trial personnel.
8. In cases where preparation of a formal IB is impractical, the sponsor-investigator
should provide, as a substitute, an expanded background information section in the
trial protocol that contains the minimum current information described in this
guideline.
NOTE - (IRBs - INSTITUTIONAL REVIEW BOARDS, IECs - INDEPENDENT ETHIC COMMITTEES.)
SOURCE :- ICH GCP - INVESTIGATION BROCHURE.PDF

12. B-TABLE OF CONTENT OF IB
 GENERAL CONSIDERATIONS THE IB SHOULD INCLUDE :-
1. “Title Page”
This should provide the sponsor’s name, the identity of each investigational product (i.e.,
research number, chemical or approved generic name, and trade name(s) where legally
permissible and desired by the sponsor), and the release date. It is also suggested that an edition
number, and a reference to the number and date of the edition it supersedes, be provided.
2. Confidentiality Statement
The sponsor may wish to include a statement instructing the investigator/recipients to treat the
IB as a confidential document for the sole information and use of the investigator’s team and the
IRB/IEC.
SOURCE :- ICH GCP - INVESTIGATION BROCHURE.PDF

13. CONT…
APPE NDIX OF GENERAL CONSIDERATIONS
1. TITLE PAGE
2. SPONSOR’S NAME
3. Product:
4. Research Number:
5. Name(s): Chemical, Generic (if approved)
6. Trade Name(s) (if legally permissible and desired by the sponsor)
7. INVESTIGATOR’S BROCHURE
8. Edition Number:
9. Release Date:
10. Replaces Previous Edition Number:
11. Date:
SOURCE :- ICH GCP - INVESTIGATION BROCHURE.PDF

14. CONT…
 Main Contents of the Investigator’s Brochure.
Confidentiality Statement (optional)
Signature Page (optional)
1- Table of Contents
2- Summary
3- Introduction
4- Physical, Chemical, and Pharm
5- Nonclinical Studies
5.1- Nonclinical Pharmacology
5.2 -Pharmacokinetics and Product Metabolism in Animals
5.3- Toxicology
6- Effects in Humans
6.1- Pharmacokinetics and Product Metabolism in Humans
6.2- Safety and Efficacy
6.3- Marketing Experience
7- Summary of Data and Guidance for the Investigator.
SOURCE :- ICH GCP - INVESTIGATION BROCHURE.PDF

15. DIFFERENCE BETWEEN IMPD & IB
INVESTIGATIONAL
MEDICINAL PRODUCT
DOSSIER (IMPD)
1. IT MAINLY FOCUSES ON
NON-CLINICAL DATA & IT
DETAILS THE METHOD OF
DEVELOPMENT,
MANUFACTURE,
PACKAGING, STORAGE.
INVESTIGATION
BROCHURE
1. IT MAINLY FOCUSES ON
CLINICAL AS WELL AS
NON-CLINICAL DATA
SOURCE :- INTERNET SOURCE

16. PROCEDUREFOR CONDUCTINGCLINICAL TRAILS WITHCOMPARISONBETWEEEN
“USFDA & EUROPEANUNION”
USFDA
1. INVESTIGATIONAL NEW DRUG
(IND)
2. MAY “CHOOSE” TO INSPECT
GENERALLY BASED ON IND
REVIEW
3. VERY RARE FOR FDA TO
INSPECT EVEN IN PHASE-E OF
CLINICAL TRAILS
EUROPEAN UNION
1. INVESTIGATIONAL MEDICINAL
PRODUCT DOSSIER/CLINICAL
TRIAL APPLICATION (CTA)
2. OBLIGED TO INSPECT UNDER
CLINICAL TRIAL DIRECTIVE (IN
THIRD COUNTRY THIS MIGHT
BE A QP AUDIT RATHER THAN
COMPETENT AUTHORITY
3. INSPECTIONS ARE COMMON
(QP- QUALIFIED PERSON)
SOURCE :- INTERNET SOURCE

17. “USFDA & EUROPEAN UNION”
FILING PROCEDURE
USFDA
“FORM NO- 1571 FOR THE IND”
FOLLOWING ARE DOCUMENTS :-
1. COVER LETTER
2. FORM (1571)
3. TABLE OF CONTENT
4. INTRODUCTION STATEMENT
5. GENERAL INVESTIGATION PLAN
6. INVESTIGATOR’S BROCHURE
7. PROTOCOL
8. CMP,
9. PHARMACOLOGY,
10. TOXICOLOGY
USUALLY GETS APPROVED IN 30 DAYS
(IF ANY, CROSS EXAMINATION ISN’T SAID
BY THE AUTHORITIES WITHIN THE SPAN OF
30 DAYS WHILE OR AFTER CHECKING THE
SUBMITTED DOCUMENTS THEN THE
PERSON HAVE THE RIGHTS TO CONDUCT
THE TRIALS)
1
2
4
3
5
SOURCE :- INTERNET SOURCE

18. THANK YOU VERY MUCH EVERYONE