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Document Sample
European Medicines Agency
Pre-authorisation Evaluation of Medicines for Human Use
London, <date>
Doc. Ref:
DRAFT
CHMP Day 120 List of Questions
<Invented Name>
<(Active Substance)>
EMEA/H/C/{nnnn}/{nnn}/{nnn}
Applicant:
Rapporteur:
Co-Rapporteur:
EMEA PTL:
Start of the procedure:
Date of this report:
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 <sector nr>
E-mail: mail@emea.europa.eu. http://www.emea.europa.eu
TABLE OF CONTENTS
I. RECOMMENDATION ...................................................................................................................... 6
II. EXECUTIVE SUMMARY ............................................................................................................. 6
II.1 Problem statement........................................................................................................................... 6
II.2 About the product ........................................................................................................................... 6
II.3 The development programme/Compliance with CHMP Guidance/Scientific Advice .............. 6
II.4 General comments on compliance with GMP, GLP, GCP .......................................................... 6
II.5 Type of application and other comments on the submitted dossier............................................ 6
III. SCIENTIFIC OVERVIEW AND DISCUSSION ......................................................................... 8
III.1 Quality aspects ............................................................................................................................. 8
III.2 Non clinical aspects ..................................................................................................................... 8
III.3 Clinical aspects ............................................................................................................................ 8
IV. ORPHAN MEDICINAL PRODUCTS .......................................................................................... 9
V. BENEFIT RISK ASSESSMENT ................................................................................................. 10
V.1 Conclusions .................................................................................................................................... 10
VI. CHMP LIST OF QUESTIONS .................................................................................................... 11
VI.1 Quality aspects ............................................................................................................................... 11
VI.2 Non clinical aspects ....................................................................................................................... 11
VI.3 Clinical aspects .............................................................................................................................. 11
VII. RECOMMENDED CONDITIONS FOR MARKETING AUTHORISATION AND
PRODUCT INFORMATION .................................................................................................................. 12
VII.1 Conditions for the marketing authorisation ........................................................................... 12
VII.2 Summary of Product Characteristics (SPC) ........................................................................... 12
VII.3 Labelling ..................................................................................................................................... 12
VII.4 Package Leaflet (PL) ................................................................................................................. 12
APPENDIX (As appropriate) ................................................................................................................... 13
<Invented name> 2/15 CHMP D120 LoQ rev.10/09
ADMINISTRATIVE INFORMATION
Invented name of the medicinal
product:
INN (or common name) of the active
substance(s):
Applicant:
Applied Indication(s)
Pharmaco-therapeutic group
(ATC Code):
Pharmaceutical form(s) and strength(s):
Rapporteur contact person: Name
Tel:
Fax:
Email:
Co-Rapporteur contact person: Name
Tel:
Fax:
Email:
EMEA Product Team Leader: Name
Tel:
Fax:
Email:
Names of the Rapporteur assessors Quality:
(internal and external): Name(s)
Tel:
Fax:
Email:
Non-clinical:
Name(s)
Tel:
Fax:
Email:
Clinical :
Name(s)
Tel:
Fax:
Email:
Names of the Co-Rapporteur assessors Quality:
(internal and external): Name(s)
Tel:
Fax:
Email:
Non-clinical:
<Invented name> 3/15 CHMP D120 LoQ rev.10/09
Name(s)
Tel:
Fax:
Email:
Clinical :
Name(s)
Tel:
Fax:
Email:
<Invented name> 4/15 CHMP D120 LoQ rev.10/09
LIST OF ABBREVIATIONS
<Invented name> 5/15 CHMP D120 LoQ rev.10/09
I. RECOMMENDATION
Based on the CHMP review of the data on quality, safety and efficacy, the CHMP considers that the
application for <product name> <an orphan medicinal product> in the treatment of <claimed indication>,
<is approvable. The CHMP considers some points could be resolved after the marketing authorisation. See
section VII.>
<could be approvable provided that satisfactory answers are given to the "other concerns" as detailed in
the List of Questions. Failure to resolve other concerns may render the application unapprovable>
<In addition, the CHMP has recommended conditions for marketing authorisation and product
information. (see section VII).>
<However, the answers to the "other concerns" may affect the final product information and/or other
conditions for the marketing authorisation.>
<is not approvable since "major objections" have been identified, which preclude a recommendation for
marketing authorisation at the present time. The details of these major objections are provided in the List
of Questions (see section VI).>
<In addition, satisfactory answers must be given to the "other concerns" as detailed in the List of
Questions.>
<The major objections precluding a recommendation of marketing authorisation, pertain to the following
principal deficiencies:>
<Deficiencies arising from concerns over the confidential (ASM - Active Substance Manufacturer
restricted) part of the DMF are mentioned in the appendix (this appendix is not supplied to the MAA).
These concerns will be conveyed in confidence to the holder of the DMF.>
Questions to be posed to additional experts
Inspection issues
II. EXECUTIVE SUMMARY
II.1 Problem statement
II.2 About the product
II.3 The development programme/Compliance with CHMP Guidance/Scientific Advice
II.4 General comments on compliance with GMP, GLP, GCP
II.5 Type of application and other comments on the submitted dossier
Legal basis
Conditional approval
Approval under exceptional circumstances
<Invented name> 6/15 CHMP D120 LoQ rev.10/09
Accelerated procedure
Biosimilarity
1 year data exclusivity
Significance of paediatric studies
<Invented name> 7/15 CHMP D120 LoQ rev.10/09
III. SCIENTIFIC OVERVIEW AND DISCUSSION
The structure of this AR is in accordance with the Day 80 Overview and will be updated at the different
stages of the CHMP review (Day 150/180/CHMP AR/EPAR) so as to constitute a self standing
document. See also the Day 80 Overview Guidance.
It should therefore be sufficiently detailed to eventually be used for the CHMP (Withdrawal) AR and
(W)EPAR and give sufficient justifications for the LoQ/LoOI as appropriate.
Tables and graphs to display results are encouraged.
III.1 Quality aspects
Drug substance
Drug Product
Discussion on chemical, pharmaceutical and biological aspects
Conclusions on the chemical, pharmaceutical and biological aspects
III.2 Non clinical aspects
Pharmacology
Pharmacokinetics
Toxicology
Ecotoxicity/environmental risk assessment
Discussion on non-clinical aspects
Conclusion on non-clinical aspects
III.3 Clinical aspects
Tabular overview of clinical studies
Pharmacokinetics
Pharmacodynamics
Discussion on clinical pharmacology
Conclusions on clinical pharmacology
Clinical efficacy
Dose-response studies and main clinical studies
<Invented name> 8/15 CHMP D120 LoQ rev.10/09
Clinical studies in special populations
Analysis performed across trials (pooled analyses AND meta-analysis)
Supportive study(ies)
Discussion on clinical efficacy
Conclusions on clinical efficacy
Clinical safety
Patient exposure
Adverse events
Serious adverse events and deaths
Laboratory findings
Safety in special populations
Immunological events
Safety related to drug-drug interactions and other interactions
Discontinuation due to AES
Post marketing experience
Discussion on clinical safety
Conclusions on clinical safety
Pharmacovigilance system
Risk Management plan
Safety Specification
Pharmacovigilance Plan
Evaluation of the need for a Risk Minimisation plan
Risk Minimisation plan
IV. ORPHAN MEDICINAL PRODUCTS
<According to the conclusion of the COMP (Opinion dated 00/00/00) the prevalence of the “condition”
<state the condition> is <> per 10000 individuals in the EU.>
<N/A>
<Invented name> 9/15 CHMP D120 LoQ rev.10/09
(If an orphan drug has been authorised in the same indication during this 1st phase of the evaluation
procedure, request the company to submit a report on similarity and the data to support clinical
superiority)
V. BENEFIT RISK ASSESSMENT
(Update this section at Day 150/180). See Day 80 template/guidance for instructions)
Benefits
Beneficial effects
Uncertainty in the knowledge about the beneficial effects
Risks
Unfavourable effects
Uncertainty in the knowledge about the unfavourable effects
Balance
Importance of favourable and unfavourable effects
Benefit-risk balance
Discussion on the benefit-risk assessment
V.1 Conclusions
The overall B/R of <name of product> <is> <positive> provided <general statement on conditions>; is
<negative>
<Invented name> 10/15 CHMP D120 LoQ rev.10/09
VI. CHMP LIST OF QUESTIONS
(Make cross-references from the actual question to what is stated in the scientific discussion. Try to limit
the “other concerns” to what is needed to know.)
VI.1 Quality aspects
Major objections
Drug substance
Drug product
Other concerns
Drug substance
Drug product
VI.2 Non clinical aspects
Major objections
Pharmacology
Pharmacokinetics
Toxicology
Other concerns
Pharmacology
Pharmacokinetics
Toxicology
VI.3 Clinical aspects
Major objections
Pharmacokinetics
Pharmacodynamics
Clinical Efficacy
Clinical Safety
Pharmacovigilance system
<Invented name> 11/15 CHMP D120 LoQ rev.10/09
Risk Management plan
Other concerns
Pharmacokinetics
Pharmacodynamics
Clinical Efficacy
Clinical Safety
Pharmacovigilance system
Risk Management plan
VII. RECOMMENDED CONDITIONS FOR MARKETING
AUTHORISATION AND PRODUCT INFORMATION
VII.1 Conditions for the marketing authorisation
VII.2 Summary of Product Characteristics (SPC)
VII.3 Labelling
VII.4 Package Leaflet (PL)
User consultation
<Invented name> 12/15 CHMP D120 LoQ rev.10/09
APPENDIX (AS APPROPRIATE)
CHMP questions on the ASM (Active Substance Manufacturer) restricted
part of the DMF
NOTE that this annex should not be sent to the MAH but only to the holder
of the DMF.
<Invented name> 13/15 CHMP D120 LoQ rev.10/09
CHMP questions on the ASM restricted part of the DMF
<Invented name> 14/15 CHMP D120 LoQ rev.10/09
PART II: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL ASPECTS
<Invented name> 15/15 CHMP D120 LoQ rev.10/09
