insert full date insert doc. ref. committee for advanced therapies (cat) send this report to the cat mailing list and the emea co
Committee for Advanced Therapies (CAT)
Certification Evaluation Report
International Nonproprietary Name:
Procedure No. EMEA/H/C/XXX >
Status of this report:
1 D40 Evaluation report – date: dd/mm/yyyy – Comments by: date:
dd/mm/yyyy
D55 Evaluation report, updated following CAT comments – date:
dd/mm/yyyy
D60 CAT Request for Supplementary Information (RSI, see IV.) – date:
dd/mm/yyyy
- Responses to RSI from the Applicant received on: dd/mm/yyyy
D75 Evaluation of responses – date: dd/mm/yyyy – Comments by:
dd/mm/yyyy
D85 Updated Evaluation of responses following CAT comments – date:
dd/mm/yyyy
dd/mm/yyyy
The information contained in the report is considered commercially
confidential and may not be disclosed to third parties in accordance
with the ‘Principles to be applied for the deletion of commercially
confidential information for the disclosure of EMEA documents’.
CAT Coordinator:
CAT Peer Reviewer(s):
EMEA Coordinator :
Start of the procedure:
ADMINISTRATIVE INFORMATION
Invented name of the medicinal product:
INN (or common name) of the active substance(s):
Applicant:
Indication(s)
Pharmaco-therapeutic group
(ATC Code):
Pharmaceutical form(s) and strength(s):
CAT Lead Coordinator’s contact person:
CAT Peer reviewer’s contact person2*:
EMEA Coordinator:
Name
Tel:
Fax:
Email:
Name
Tel:
Fax:
Email:
Name
Tel:
Fax:
Email:
Names of the CAT Lead Coordinator’s assessors:
(Internal and external)
Names of the CAT peer reviewer’s assessors:
(Internal and external)
Quality:
Name(s)
Tel:
Fax:
Email:
Non-clinical:
Name(s)
Tel:
Fax:
Email:
Quality:
Name(s)
Tel:
Fax:
Email:
Non-clinical:
Name(s)
Tel:
Fax:
Email:
Table of Content
1. Introduction 5
2. EXECUTIVE SUMMARY 5
3. EVALUATION 6
3.1 Module 2: 6
3.2 Module 3: Quality EVALUATION 6
3.3
4. REQUEST FOR SUPPLEMENTARY INFORMATION 13
5. EVALUATION OF THE RESPONSES TO THE REQUEST FOR SUPPLEMENTARY
INFORMATION 14
6. OVERALL CONCLUSION
LIST OF ABBREVIATIONS
CAT: Committee for Advanced Therapies
NB: Notified Bodies
1. Introduction
===============
Submission of the dossier for certification:
Agency (EMEA) for
Article 18 of Regulation (EC) No 1394/2007.
following sections of:
Module 3
been issued on
with Article 2 of Regulation (EC) No 1394/2007/EC.
Steps taken for the evaluation of the certification procedure:
*
The application was received by the EMEA on
*
The procedure started on
*
The CAT Coordinator’s first Evaluation Report was circulated to
all CAT members on
*
During the meeting on
consolidated Request for Supplementary Information (RSI) to be
sent to the applicant.
*
The applicant submitted the responses to the CAT consolidated
Request for Supplementary Information on
*
issued on
*
were issued on
*
The CAT Coordinator circulated the updated CAT Coordinator’s
Evaluation Report on the applicant’s responses to the Request for
Supplementary Information to all CAT members on
*
On
to the CAT.
*
During the meeting on
overall data submitted and the scientific discussion within the
Committee, issued a positive opinion for granting a certificate to
2. EXECUTIVE SUMMARY
====================
Scope of the certification:
Modules affected:
Modules 3
Site visits:
application. >
Consultation of Notified Body (NB):
certification application. >
3. EVALUATION
=============
This discussion should be updated to take into account comments from
CAT members, the EMEA and discussions at Working Parties and CAT and
provide clearly the scientific rationale for the recommendation and
for the objections and concerns/request for supplementary information
listed in section IV.
Only the modules which have been submitted by the applicant should be
listed in this section. Therefore, when some modules have not been
provided, please state “Not applicable”.
3.1 Module 2:
-------------
INTRODUCTION
RISK analysis exercise
3.2 Module 3: Quality EVALUATION
--------------------------------
REQUESTS FOR SITE VISIT(S) ACTION PRIOR TO CERTIFICATION:
Objectives of the site visit(s)
REQUESTS OF A NOTIFIED BODY (NB) INFORMATION OR RESULTS OF NB
ASSESSMENT ACTION PRIOR TO CERTIFICATION:
INTRODUCTION
DRUG SUBSTANCE
*
General Information
*
Manufacture
*
Characterisation
*
Control of Drug Substance
*
Reference Standards or Materials
*
Container Closure System
*
Stability
DRUG PRODUCT
*
Description and Composition of the Drug Product
*
Pharmaceutical Development
*
Manufacture
*
Control of Excipients
*
Control of Drug Product
*
Reference Standards or Materials
*
Container Closure System
*
Stability
APPENDICES
A.1 Facilities and Equipment
A.2 Adventitious Agents Safety Evaluation
A.3 Novel Excipients
REGIONAL INFORMATION
*
Medical Device issues
*
TSE Issues
3.3
---------------------------------------
INTRODUCTION
*
Type of application and aspects on development
*
GLP aspects
PHARMACOLOGY
*
Brief summary
Assessor’s comment
Primary pharmacodynamics
Assessor’s comment
Secondary pharmacodynamics
Assessor’s comment
Safety pharmacology
Assessor’s comment
Pharmacodynamic drug interactions
Assessor’s comment
PHARMACOKINETICS
*
Pharmacokinetic studies
Assessor’s comment
*
Methods of analysis
Assessor’s comment
*
Absorption
Assessor’s comment
*
Biodistribution
Assessor’s comment
*
Metabolism
Assessor’s comment
*
Excretion
Assessor’s comment
Pharmacokinetic drug interactions
Assessor’s comment
Other pharmacokinetic studies
Assessor’s comment
TOXICOLOGY
*
Single dose toxicity
Assessor’s comment
*
Repeat-dose toxicity
Assessor’s comment
*
Toxicokinetics
Assessor’s comment
*
Interspecies comparison
Assessor’s comment
Genotoxicity
Assessor’s comment
Carcinogenicity
Tumorigenic potential
Assessor’s comment
Reproductive and developmental toxicity
Assessor’s comment
Germline transmission
Assessor’s comment
*
Embryo-fœtal development
Assessor’s comment
*
Prenatal and postnatal development, including maternal function
Assessor’s comment
*
Studies in which the offspring (juvenile animals) are dosed and/or
further evaluated
Assessor’s comment
Local tolerance
Assessor’s comment
Other toxicity studies
Assessor’s comment
*
Immunotoxicity and Immunogenicity
Assessor’s comment
*
Metabolites
Assessor’s comment
*
Studies on impurities
Assessor’s comment
*
Other studies
Assessor’s comment
Assessor’s comment
This evaluationt report should be’ self-standing’. This may be
achieved in two ways:
1. Presenting or copying data which are taken from the applicant’s
dossier, followed by the assessor’s own critical evaluation of these
data highlighting adherence to specific guidance documents. The
heading ‘Assessor’s Comments’ should be introduced as a separator in
this case, to avoid confusion.
2. Alternatively, this report may consist largely* of the assessor’s
own views with references to the applicant’s own data and/or Quality
Overall Summary (QOS) and Non-clinical Overview. In this case, the
additional headings for assessor’s comments would not be needed.
* a limited amount of the applicant’s data such as flow diagrams,
specifications etc. may be copied in, to facilitate the reading of the
report.
DO NOT delete any of these sections in case of a request for
supplementary information: there are needed for the evaluation of the
responses.
Do not delete before comments from CAT members are available, it may
be necessary to have a RSI.
Sections IV. to VI. can be deleted if not applicable(only when sure
that a RSI is not applicable).
4. REQUEST FOR SUPPLEMENTARY INFORMATION
========================================
It is vital that the structure and content of a major data/studies
deficiency are clear. Detailed comments may be necessary along with a
reference to guidance documents.
With the RSI only clarification on the data already submitted should
be requested, not new data.
has been requested and its outcome has not yet been
confirmed. The evaluation procedure is suspended until finalisation of
the site visit and the report.>
Body (NB) on the medical device part >
part by the NB <> has been requested and its outcome has not yet been
confirmed. The certification procedure is suspended until receipt of
the information requested/ results of the assessment of the medical
device.>
Information to the Applicant: A clock-stop of 30 days will apply and
clarifications should be submitted in accordance with the timetables
published on the EMEA website. In order to expedite the resolution of
minor issues, the Applicant may request to submit responses on the
Monday following the adoption of the request for supplementary
information by CAT. If a clock stop longer than 1 month is required to
respond, the Applicant should send a justified request to the EMEA for
agreement by CAT. Such requests should be sent after receipt of the
Evaluation Report, and at the latest one week before the CAT meeting
at which the request for supplementary information will be adopted.
In case of a site visit/consultation of a NB the procedure is
suspended until a report/information/results of assessment of the NB
is made available to the EMEA and the CAT.
5. EVALUATION OF THE RESPONSES TO THE REQUEST FOR SUPPLEMENTARY
INFORMATION
===============================================================
<5.1 Concerns/clarification>
Question X - Summary of the Applicant’s response
Evaluation of the Applicant’s response
Conclusion
6. OVERALL CONCLUSION
=================================================================
Major data/studies deficiencies can lead to a negative opinion or to a
partial positive opinion (only on certain data) and therefore to a
partial certification.
Based on the rationale provided by the Applicant and the overall
review of the quality data, the CAT Coordinator considers…..
3 The
certification of the quality
listed in section 1 of this report.
authorisation as regards the compliance with the scientific and
technical requirements of Annex I to Directive 2001/83/EC of the
quality and, where applicable, non-clinical data submitted, and the
corresponding testing methodologies followed by the applicant>:
Module 3
-
-
The
certification of the quality
grounds for negative opinion for the certification are the follwoing:
-
-
the list of issues in Annex II of this report are adequately addressed
in the application for a marketing authorisation, as regards the
compliance with the scientific and technical requirements of Annex I
to Directive 2001/83/EC of the quality and, where applicable,
non-clinical data submitted, and the corresponding testing
methodologies followed by the applicant. >
===================================================================
======================================================================
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Certification Evaluation Report
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