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Marketing Authoisation Application Flashcards

1
Q

What are medicines approve of?

A

Approval of Quality, Safety and Efficacy

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2
Q

What are some examples for quality, safety and Efficacy

A

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

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3
Q

How do the agencies decide if a MP receive a MA

A

it is accessed accrodingto the Risk-Benefit Ratio

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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

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5
Q

when is the MP approved?

A

if the risk-benefit ratio is greater than 1

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6
Q

what are some EMA guidance document o the RBR asessment?

A

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

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7
Q

What is the advantge of the Effect table?

A

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

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8
Q

For which MP are MA needed?

A

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

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9
Q

What are some exception for MA?

A

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

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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)

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11
Q

Which national authorities do we have in germany?

A

EMA, BfArm, PEI, RKI, BVL

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12
Q

What are the European Network?

A

EMA and HMA

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13
Q

the EMA is responsible for?

A

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

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14
Q

the HMA is responsible for?

A

Decentralized EU-procedures

secure the efficient collaboration of national authorities

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15
Q

What are the committees in the EMA?

A

PRAC, CAT, COMP, PDCO, CMPH

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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)

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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

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18
Q

Full application are required for?

A

New active and known active substance

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19
Q

Which Dossier are required for a full application?

A

CTD:Module 1, PIP /defrral or waiver

Full dossier: Moduel 2-5

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20
Q

Which MP falls under the Abridged application?

A

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

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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
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22
Q

Well-establised use application are for?

A

API used for more tha 10 years

Safety and efficency well-established

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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

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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

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25
Dossier for informed cocent application?
Only Module 1 (PIP/deferral/waiver) | Reference to approved Modules 2-5
26
Hybrid application for?
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
27
Dossier for hycrid application
Module 1(no pip/waiver/deferral) Module 2 complete Moduel 3 Module 4 and 5 based on literature or own study report
28
Similar biological application for?
Biosimilar rpoduct is referrring to a reference biological product
29
Dossier for bio-similar
Module 1( no PIP/waiver/ deferral) Module 2 complete Module 3 Module 4 and 5 based on literature
30
for which application form are no PIP needed?
Abridged, well-established use, hybrid, similar biological application
31
Which application need a PIP
Full application and informed constent application
32
For which application can Module 4 and 5 based on literature?
Abridged, Well-estabished use, hybrid, Bio-similars
33
What are the MA procedures?
National authorisation Decentralized procedure and Mutual recognition procedure Centralized procedure
34
National authorisation procedure is?
One MAA process valid in one member state across the EU
35
DP/MRP is ?
At least two national MA valid in at least two EU MS
36
CP is
one market authorization valid in the entire EU
37
what is the national procedure?
1. Directive 2. Additional National law needes to be considered 3. No defined timeline
38
Mutual recognitio procedure
Heads of medicines agencies (HMA)
39
what is the requirement for the MRP?
a national authorization is pre-exist,which is for the reference member state
40
What does the RMS does?
they asked for recognition o other EU member states, which are refer to as the concerned member states
41
is repeatation in MRP accepted?
yes, the same procedure can be carry out via repeat used procedure
42
Who coordinate the MRP?
the RMS, they discussed with the CMS
43
on what is the approval based on in the MRP?
the CMS has to give its concern about non serious risk to public health
44
What happend if the CMS say there is a risk to the public health?
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
decentralized procedure process?
for MP not yet received a market authorization in the EU (e.g not allowed to follow CP)
46
how is the submission carry out in DP?
Paralel submission in diferrent member states RMS is selected All countries evaluated in detail National licences by each member state
47
central procedure
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
Central procedure is mandatory for
New actives substances for treatment of (HIV, cancer) Orphan medicines Medicines derived from biotechnology Advanced-therapy medecines (gen-therapy)
49
CP is optional for?
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
what are the pre-subsmission activites?
``` Classification: Pharmaceutical ? Medical Device? RF? SME status? Orphan dug status ect ```
51
what happend at the pre-submission meeting?
Appointment of Rapporteurs (CHMP & PRAC) submission of the application Validation of the dossier
52
When is day zero defined?
after the validation of the dossier is sucessful
53
What happend after the validation?
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
what happend after the 80 days?
the CHMP have to give their comments on the SAR within 20 days
55
What does the SAR content?
Overview (inclduing conclusion on bebefit risk questions quality Non-clinical Clinical
56
which comments are made by the CHMP?
preparation of the list of questions | Report of the biologicals Working party
57
what does 120 includes?
List f questions | GMP/GLP/GCP inspection request
58
what happened afte day 120?
1 clock stop (normally 3 months)
59
what happend after the 3 months of clock stop
Restart of the clock on 121, following submission of responses by applicant
60
What takes place after responese are received?
the Rapp / Co-rapp has to write a SAR within 30 day
61
on day 157?
CHMP and PRAC rapportures write a joint assessemnt report
62
the joint AR includes?
``` overview qaulity Non-clinical Clinical RMP ```
63
on day 180?
the CHMP discussion including decision on need for a list of outstanding isssues or oral explanantion second clock stop
64
what happend when the applicants receiveda positive CHMP opinion? (day 210)
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
On day 235?
Applicant provides EMA with final translation o product information nad all related documents
66
on day 237
EMA-tranmission of CHMP opinion and translated product information to EC
67
on day 277
EC decision positive, valid MA acros the EU

Drug Regulatory Affairs (15 decks)

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