Investigation of medicinal product dossier (IMPD)

1. Investigation of Medicinal
Product Dossier (IMPD)
Presented by: Guided by:
Himal Barakoti Rituraj Bharadwaj
M. Pharm, 1st Sem Associate Professor
Department of Pharmacy Department of Pharmacy
Assam Down Town University Assam Down Town University

2. Contents:
 European medicines Agency (EMA)
 IMPD: Introduction
 Contents of IMPD
 Objectives
 Scope
 Guidance and legal basic
 References
2/17/2018
2
Department of Pharmacy, Assam Down Town University

3.  European Medicines Agency (EMA) is a decentralized agency of the
European union.
 The Management Board is the European Medicines Agency’s integral
governance body.
 The Agency is responsible for the scientific evaluation, supervision and
safety monitoring of the medicines developed by pharmaceutical
companies for the use in EU.
 EMA protects public and animal health in 27 EU member states, as well as
the countries of the European Economic Area, by ensuring that all
medicines available on the EU market are safe, effective and of high
quality.
 EMA serves a market of over 500 million people living in EU.
2/17/2018Department of Pharmacy, Assam Down Town University
3

4. History
 European medical agency was founded in 1995, has worked across the EU
and globally to protect public and animal health by assessing medicines to
rigorous scientific standards and providing with independent, science-based
information on medicines.
 EMA has 20 year track record of ensuring efficacy and safety of human and
veterinary medicines across Europe, and promoting research and innovation in
the development of medicines.
 In first two decades, the agency recommended the authorization of the total of
975 human and 188 veterinary medicines
2/17/2018Department of Pharmacy, Assam Down Town University
4

5. Drug approval process
 There are two regulatory steps to go through before a drug is approved to be
marketed in the EU.
 These two steps are:-
1. Clinical trial application
2. Marketing authorization application
 Clinical trial applications are approved at the member state level. Marketing
authorization applications are approved at both the member state or
centralized levels.
 Qualified person has to certify that the investigational medicinal product
(IMP) is manufactured according to GMP.
 The competent Authority has the right to inspect the manufacturing facility for
GMP compliance, the preclinical facility for GLP compliance and the clinical
trial sites for GCP compliance.
2/17/2018Department of Pharmacy, Assam Down Town University
5

6. Clinical Trial Application:
 EU Directive 2001/20/EC (April 2001) sets out the new rules and regulations for
the approval and conduct of clinical trials in Europe.
 A sponsor submits a clinical trial application to the Competent Authority in
each Member State where the trials are to be conducted.
 The Competent Authority has 60 days to review and approve or reject the
application.
 Application is in prescribed forms and cover the proposed clinical trial protocol,
manufacturing and quality controls on the drug and supporting data, such as:
- chemical, pharmacological and biological data
- non-clinical pharmacological and toxicological data
- previous human experience and clinical data (if any)
2/17/2018Department of Pharmacy, Assam Down Town University
6

7. Investigational Medical product Dossier
 The IMPD is the basis for approval of clinical trials by the competent authorities
in the EU.
 The Clinical Trial Directive came in force, harmonizing the laws, regulations
and administrative provisions of the Member states relating to the
implementation of GCP in the conduct of clinical trials on medicinal
products for human use.
 The directive introduced a harmonized procedure for the authorization to
perform a clinical study in any one of the EU Member States.
 In addition, it defines the documentation to be submitted to the Ethics
Committee as well as the Investigational Medicinal Product Dossier (IMPD)
to be submitted to the competent authority for approval.
2/17/2018Department of Pharmacy, Assam Down Town University
7

8. Introduction
 Dossier
“a collection of documents about a particular person, event or subject”
E.g. Patient’s medical record
M. pharm academic dossier
 Medicinal product dossier
“ File containing detailed records about a particular drug product”
2/17/2018
8
Department of Pharmacy, Assam Down Town University

9. IMPD: contents
 IMPDs are submitted as part of clinical trial application dossier, as the
basis for approval of clinical trials by competent regulatory authorities
within European Union.
IND application are equivalent in U.S.
Contents: subsequent trial documentation
1. protocols
2. informed consent forms
3. investigator brochure
4. study reports
5. subject narratives
6. Risk management plans
7. Periodic safety update reports
2/17/2018
9
Department of Pharmacy, Assam Down Town University

10. The IMP dossier required will depend on many factors including:
 risk aspects
 nature of the product nature of the product
 state of development
 patient population patient population
 nature and severity of the illness
 type and duration of the clinical trial itself
2/17/2018Department of Pharmacy, Assam Down Town University
10

11. What is an IMPD?
The Investigational Medicinal Product Dossier (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.
2/17/2018
11
Department of Pharmacy, Assam Down Town University

12. Objectives
Since clinical trials will often be designed as multi-center studies,
potentially involving different Member States, it is the aim of this guideline to
define harmonized requirements of the documentation to be submitted
throughout the European Community.
2/17/2018Department of Pharmacy, Assam Down Town University
12

13. Scope
 Guideline addresses the documentation on the chemical and pharmaceutical
quality of IMPs containing chemically defined active substances,
synthetic peptides, herbal substances, herbal preparations and
chemically defined radio-active/radio-labelled substances to be submitted
to the competent authority for approval prior to beginning a clinical competent
authority for approval prior to beginning a clinical trial in humans.
 It includes the requirements for IMPs to be tested in phase I, phase II and
phase III studies as well as the requirements for modified and unmodified
comparator requirements for modified and unmodified comparator
products and IMPs to be tested in generic bioequivalence studies [and
placebo products]
2/17/2018Department of Pharmacy, Assam Down Town University
13

14. 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 relating to the implementation of good clinical practice in the conduct of
clinical trials on medicinal products for human use (also commonly referred to as
the ‘Clinical Trials Directive’).
 The Regulation comes into force, harmonising 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.
2/17/2018
14
Department of Pharmacy, Assam Down Town University

15. The IMPD includes summaries of information related to the
quality, manufacture and control of the Investigational Medicinal Product,
data from non-clinical studies and from its clinical use.
An overall risk-benefit assessment, critical analyses of the non-clinical
and clinical data in relation to the potential risks and benefits of the proposed study
have to be part of the IMPD.
In certain situations, e.g. where the Investigational Medicinal Product
has already been authorised as a medicinal product in one of the EU Member
States or where clinical studies with the IMP have already been approved by a
Member State, a simplified IMPD will be sufficient.
2/17/2018
15
Department of Pharmacy, Assam Down Town University

16. References:
 http://www.ema.europa.eu/ema/
 http://www.imp-dossier.eu/
 http://www.impd.eu/
 http://www.imp-dossier.eu/imdp_guidance/
2/17/2018
16
Department of Pharmacy, Assam Down Town University

17. 2/17/2018
17
Department of Pharmacy, Assam Down Town University