Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Drug Regulatory Affairs > Marketing Authoisation Application > Flashcards

Marketing Authoisation Application Flashcards

1
Q

What are medicines approve of?

A

Approval of Quality, Safety and Efficacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What are some examples for quality, safety and Efficacy

A

Q: Development, production
S: Toxicology, Adverse events
E: Clinical study, GCP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

How do the agencies decide if a MP receive a MA

A

it is accessed accrodingto the Risk-Benefit Ratio

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

what is the defination of risk-benefit ratio

A

it is the balance between therapeutic efficacy and saftey risks, which relies mainly on a qualitative assessment of quantitative data

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

when is the MP approved?

A

if the risk-benefit ratio is greater than 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

what are some EMA guidance document o the RBR asessment?

A

Disease, Available therapies and medical need
Main clinical studies
Effects table

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is the advantge of the Effect table?

A

it is a clear standard, well structure and has a systematic approach

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

For which MP are MA needed?

A

Medicines (original brand)
Generics
Biosimilars
Well-established used medicines e.g herbal mdecines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What are some exception for MA?

A

Compassionate use
Medicines for clinical trials
Traditional used medicines–> herbal medicines and homeopathics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Wh is allowed to ask for marketing authorization?

A

Applicant established in the community
applicant: pharmaceutical entrepreneur
Community: memberstates of EU + EEA (Norway, Iceland, Lichtenstein)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Which national authorities do we have in germany?

A

EMA, BfArm, PEI, RKI, BVL

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What are the European Network?

A

EMA and HMA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

the EMA is responsible for?

A

Centralised EU-Procedures
scientific advice, Pharmakovigilance
Regulatory consultation
Public work (EPAR)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

the HMA is responsible for?

A

Decentralized EU-procedures

secure the efficient collaboration of national authorities

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What are the committees in the EMA?

A

PRAC, CAT, COMP, PDCO, CMPH

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

the subgropus in HMA?

A

Coordination froup on mutual recognition and decentralised procedure-Human (CMDh)

Coordination froup on mutual recognition and decentralised procedure-Veterinary (CMDv)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

what’s the main different between the EMA and European Commission?

A

the EMA is subordinate t the EC and is responsible just for the evaluation and coordination of marketing applications, whereas the EC gives the final approvaö for the MP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Full application are required for?

A

New active and known active substance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Which Dossier are required for a full application?

A

CTD:Module 1, PIP /defrral or waiver

Full dossier: Moduel 2-5

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Which MP falls under the Abridged application?

A

Generics
same qulitative and quantitaive composition in active substance
Same pharamceutical form
Bioequivalence

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

Dossier for Abridged application

A 
Module 1 (no PIP/waiver/referral)
Module 2 without summaries
Complete module 3
Module 4 and 5 based on literature
BE-Study
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Well-establised use application are for?

A

API used for more tha 10 years

Safety and efficency well-established

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Dossier for Well-established use application

A

Module 1 (no PIP/waiver/referral)
Complete Module 2 and 3
Module 4 and 5 onle reference to literature

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

informed consent application for?

A

Approval should be dublicated
Same qualitative and quantitaie composition in terms of API
Same pharamceitcial form
Same or new MAH

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

Dossier for informed cocent application?

A

Only Module 1 (PIP/deferral/waiver)

Reference to approved Modules 2-5

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

Hybrid application for?

A

generic products differ with regard to indication, pharmaceutical form, strength, route of administration from orginator product
No bioequivalence can be measured
strict definition of a generic medicinal product is not met

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Dossier for hycrid application

A

Module 1(no pip/waiver/deferral)
Module 2
complete Moduel 3
Module 4 and 5 based on literature or own study report

28
Q

Similar biological application for?

A

Biosimilar rpoduct is referrring to a reference biological product

29
Q

Dossier for bio-similar

A

Module 1( no PIP/waiver/ deferral)
Module 2
complete Module 3
Module 4 and 5 based on literature

30
Q

for which application form are no PIP needed?

A

Abridged, well-established use, hybrid, similar biological application

31
Q

Which application need a PIP

A

Full application and informed constent application

32
Q

For which application can Module 4 and 5 based on literature?

A

Abridged, Well-estabished use, hybrid, Bio-similars

33
Q

What are the MA procedures?

A

National authorisation
Decentralized procedure and Mutual recognition procedure
Centralized procedure

34
Q

National authorisation procedure is?

A

One MAA process valid in one member state across the EU

35
Q

DP/MRP is ?

A

At least two national MA valid in at least two EU MS

36
Q

CP is

A

one market authorization valid in the entire EU

37
Q

what is the national procedure?

A
  1. Directive
  2. Additional National law needes to be considered
  3. No defined timeline
38
Q

Mutual recognitio procedure

A

Heads of medicines agencies (HMA)

39
Q

what is the requirement for the MRP?

A

a national authorization is pre-exist,which is for the reference member state

40
Q

What does the RMS does?

A

they asked for recognition o other EU member states, which are refer to as the concerned member states

41
Q

is repeatation in MRP accepted?

A

yes, the same procedure can be carry out via repeat used procedure

42
Q

Who coordinate the MRP?

A

the RMS, they discussed with the CMS

43
Q

on what is the approval based on in the MRP?

A

the CMS has to give its concern about non serious risk to public health

44
Q

What happend if the CMS say there is a risk to the public health?

A

the coordination will be between the HMA and CMS, and they have to come to a conclusion.
if not, the EMA finally decided if there is a pblic risk for the CMS or not

45
Q

decentralized procedure process?

A

for MP not yet received a market authorization in the EU (e.g not allowed to follow CP)

46
Q

how is the submission carry out in DP?

A

Paralel submission in diferrent member states
RMS is selected
All countries evaluated in detail
National licences by each member state

47
Q

central procedure

A

one MAAA process leads to approva in the EU/EEA
SmPC and product name is similar in all countires
harmonized requirements
Two idenpendent evaluation (Rapporture and Co-Rapporteur

48
Q

Central procedure is mandatory for

A

New actives substances for treatment of (HIV, cancer)
Orphan medicines
Medicines derived from biotechnology
Advanced-therapy medecines (gen-therapy)

49
Q

CP is optional for?

A

New active substnaces in the EU
Interest of public health
Innovative medicinal product
Medicinal product with paediatric indication
Generic medicinal products of reference medicinal product authorized by the central procedure

50
Q

what are the pre-subsmission activites?

A 
Classification: Pharmaceutical ? Medical Device?
RF?
SME status?
Orphan dug status
ect
51
Q

what happend at the pre-submission meeting?

A

Appointment of Rapporteurs (CHMP & PRAC)
submission of the application
Validation of the dossier

52
Q

When is day zero defined?

A

after the validation of the dossier is sucessful

53
Q

What happend after the validation?

A

the Rapporture and the Co-rapporture have 80 days to write a Scientific assessment report. Both SAR are indenpenten to each other
Rapp/Co-Rapp from CHMP and PRAC

54
Q

what happend after the 80 days?

A

the CHMP have to give their comments on the SAR within 20 days

55
Q

What does the SAR content?

A

Overview (inclduing conclusion on bebefit risk questions
quality
Non-clinical
Clinical

56
Q

which comments are made by the CHMP?

A

preparation of the list of questions

Report of the biologicals Working party

57
Q

what does 120 includes?

A

List f questions

GMP/GLP/GCP inspection request

58
Q

what happened afte day 120?

A

1 clock stop (normally 3 months)

59
Q

what happend after the 3 months of clock stop

A

Restart of the clock on 121, following submission of responses by applicant

60
Q

What takes place after responese are received?

A

the Rapp / Co-rapp has to write a SAR within 30 day

61
Q

on day 157?

A

CHMP and PRAC rapportures write a joint assessemnt report

62
Q

the joint AR includes?

A 
overview
qaulity
Non-clinical
Clinical
RMP
63
Q

on day 180?

A

the CHMP discussion including decision on need for a list of outstanding isssues or oral explanantion
second clock stop

64
Q

what happend when the applicants receiveda positive CHMP opinion? (day 210)

A

Within 15 applicant provides to the EMA the prodcut information and futher specific information in all 20 EU languages

MS send in linguistic comments

65
Q

On day 235?

A

Applicant provides EMA with final translation o product information nad all related documents

66
Q

on day 237

A

EMA-tranmission of CHMP opinion and translated product information to EC

67
Q

on day 277

A

EC decision positive, valid MA acros the EU

Drug Regulatory Affairs (15 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions