Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.

1. Presented by:
Mr. Sachin Fartade
M.Pharm (1st year)
Department of Pharmaceutics,
School of Pharmacy,
S.R.T.M.University, Nanded.
Guided by:
Mrs.S.S. Tiwari
Department of Pharmaceutics,
School of Pharmacy,
S.R.T.M.University, Nanded.
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2. CONTENTS
 Overview: EMA
 Drug approval process
 Clinical trial application
 IMPD: Introduction
 What is IMPD
 Format of IMPD
 Contents of IMPD
 Objectives
 Scope
 Guidance & legal basis
 References
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3. OVERVIEW: EMA
 European Medical Agency (EMA) is decentralized agency in
European Union.
 Agency is responsible for scientific evaluation supervision and
safety monitoring of medicines developed by pharmaceutical
companies for use in European Union.
 EMA protect the human and animal health in EU ensure that all
medicines available in EU market are safe effective and of high
quality.
 EU global market is 16% all over the world and 28 member state
in EU
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4. DRUG APPROVAL PROCESS
 There are two regulatory step to go through before a drug
approval to be marketed in EU.
 These two steps are: 1) Clinical trial application:
(approved at member state level)
2) Marketing authorization application:
(approved at member state level as well as centralized level)
 Qualified person has to certify IMP are manufactured according
to GMP or not.
 Competent authority has right to inspect :
1) Manufacturing facility (For GMP Compliance)
2) Preclinical facility (GLP Compliance)
3) Clinical trial sites (GCP Compliance)
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5. CLINICAL TRIAL APPLICATION:
 Directive Regulation (EU) No 536/2014 (Repealing Directive
2001/20/EC in April 2001) set new rules and regulations for
approval and conduct clinical trial in EU.
 The sponsor submit the clinical trial application to competent
authority in each member state in which clinical trials are to be
conducted.
 The competent authority has 60 days to review and approve or
reject the application.
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6. •Application is in prescribed form and cover the proposed
clinical trial protocol. Manufacturing and quality control of drug
and supporting documents such as:
- Chemical, pharmacological and biological data.
-Non clinical pharmacological and toxicological data.
(Module 4 of CTD)
- previous human experience and clinical data (If any).
• The CMC (quality) information
is presented in the IMPD - is one
of the Core Documents of CTA
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7. IMPD:INTRODUCTION
 IMPD is basis for approval of clinical trial by competent
authorities in European union.
 Clinical trial come in force harmonizing laws regulations and
harmonized procedure for authorization.
 These procedure introduced to perform clinical trial in one of
the European member state.
 It defines document to be submitted to ethics committee as
well as IMPD to be submitted competent authority for
approval.
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8. WHAT IS IMPD?
 The IMPD is one of several pieces of Investigational
Medicinal Product (IMP) related data required whenever the
performance of a clinical trial is intended in one or more
European Union Member States.
 The IMPD includes summaries of information related to
the quality, manufacture and control of any IMP (including
reference product and placebo), and data from non-clinical and
clinical studies.
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9.  FORMAT OF IMPD:
- IMPD follow the structure of CTD module (3).
- Exist guidance on sectional headings to be used in full
IMPD.
 IMPD CONTENTS:
Table of content for full IMPD follows the headings given
by guidelines.
1) Drug Substance.
2) Investigational Medical Product Under Test.
3) Appendices
IMPD are submitted as part of clinical trial application
dossier by competent regulatory Authority within European
Union.
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10. 1) DRUG SUBSTANCE:
1) General Information
i) Nomenclature
ii) Structure
iii) General Properties.
2) Manufacture:
i) Manufacturer(s)
ii) Description of Manufacturing Process and Process
iii) Control of Materials
iv) Controls of Critical Steps and Intermediates
v) Process validation and/or Evaluation
vi) Manufacturing Process Development
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11. 3) Characterization :
i) Elucidation of Structure and Other Characteristics.
ii) Impurities.
4) Control of Drug Substance:
i) Specification.
ii) Analytical Procedures.
iii) Validation of Analytical Procedures.
iv) Batch Analyses.
v) Justification of specification.
5) Reference Standards or Materials.
6) Container Closure System.
7) Stability.
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12. 2)INVESTIGATIONAL MEDICINAL
PRODUCT UNDER TEST
1) Description and Composition of the Medicinal Product:
2) Pharmaceutical Development:
i) Components of the Medicinal Product
ii) Medicinal Product
iii) Manufacturing Process Development
iv) Container Closure System
v) Microbiological Attributes
vi) Compatibility.
3) Manufacture:
i) Manufacturer(s)
ii) Batch Formula
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13. iii) Description of Manufacturing Process and Process
Controls
iv) Controls of Critical Steps and Intermediates
v) Process Validation and/or Evaluation.
4) Control of Excipients:
i) Specifications.
ii) Analytical Procedures
iii) Validation of Analytical Procedures
iv) Justification of Specifications
v) Excipients of Human or Animal Origin
vi) Novel Excipients
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14. 5) Control of Medicinal Product:
i) Specification(s)
ii) Analytical Procedures
iii) Validation of Analytical Procedures
iv) Batch Analyses
v) Characterization on impurities
vi) Justification of Specification(s)
6) Reference Standards or Materials:
7) Container Closure System:
8) Stability:
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15. 3) APPENDICES
1) Facilities and Equipment:
2) Adventitious Agents Safety Evaluation:
3) Novel Excipients:
4) Solvents for Reconstitution and Diluents:
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16. OBJECTIVE:
 Clinical trial often to be designed as multicenter studies
potentially involve in different member states.
 Aim of these guidelines to defines harmonized requirement of
documentation to be submitted throughout the European
community.
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17. SCOPE
 Guidelines addressed to IMPs containing chemically defined
active substances, synthetic peptides, herbal substance, herbal
preparation and chemically defined radio active/radio labeled
substance.
 It include requirements of IMPs to be tested in phase I, phase II
and phase III clinical studies.
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18. GUIDANCE AND LEGAL BASIS:
 The guidance is based on Regulation (EU) No 536/2014 on
Clinical Trials on Medicinal Products for Human Use
(Repealing Directive 2001/20/EC) on the approximation of
laws, regulations and administrative provisions of the Member
States.
 The Regulation comes into force in 2016, harmonizing the
laws, regulations and administrative provisions of the Member
States relating to the implementation of Good Clinical Practice
(GCP) in the conduct of clinical trials on medicinal products
for human use.
 European Member States have transformed the requirements
outlined in the Directive into the respective national laws.
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19. REFERENCES:
 http:/www.europeanmedicalagency.com
 http:/www.europeanunionimpd.com
 www.impdossier.com
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