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Drug Regulatory Affairs > Second Exercise (part 2) > Flashcards

Second Exercise (part 2) Flashcards

1
Q

Biologics are?

A

class of compounds which are manufactured by using living cells or organisms

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2
Q

Biosimilar refers to?

A

biological medicine which is comparable to it’s reference medicine.

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3
Q

what is an example of a small variation with biologics and biosilimlars?

A

glycosylation of protein chain

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4
Q

what is the distinction between generics and biosimilar?

A

generics: small molecule, same API, BE
Biosimilars: comlex molecules, highly similar to the refence product (not identical to the reference product, Non-clinical and Clinical studies

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5
Q

What has to be proven in biosimilars?

A

no clinical difference in efficacy, safety and potency to teh reference product

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6
Q

which guidelies covered the biological medicines?

A

ICH Q6B and ICH Q5E and Q5C

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7
Q

what are the three premier steps to compared biologics and biosimilar?

A

Comparative quality /analytical studies
Comparative non-clinical studies
Comparative clinical studies

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8
Q

what is the unified system in USA and EU?

A

USA: pooled system in each state of US
EU: each EU memer state has it own system for determining which therapeutics will be approved

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9
Q

what is the aim of the Article 58?

A

to promote the development of medicines for low and middle-income countires and to address unmet medical need

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10
Q

developers benefits from?

A

EMA tool kit (Scientifc advice, PRIME, AA

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11
Q

what is the eligibility for Article 58

A

cover high priority medicines that are of major public interest (HIV/AIDS, malaria or meternal and new-born health

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12
Q

what does the request content

A

eligibility for the product and SmPC

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13
Q

which authority works together in the Article submission process

A

EMA and WHO

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14
Q

what were some weaknessess of the implementation and execution?

A

Low awareness of national requlatory authories
WHO was barely invloved into the processes of the EMA
incentives for manufacturers were low ( high feed

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15
Q

What is the EU-M4all procedure?

A

rebrande of the article 58

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16
Q

what was benefical with the EU-M4all?

A

usage of the PRIME procedures,

centralized procedure

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17
Q

example of a product ( EU-M4all)

A

pyramax use for malaria

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18
Q

importation of parallel means?

A

import of products from acountry where they sold at cheaper price and exported to high-price country for resale without the permission of intellectual property (IP) authorization holders

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19
Q

what are the different types of policies for parallel import?

A

intellecutual property, trade and competition

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20
Q

three type of exhaustion are?

A

national,regional and international exhaustion

21
Q

national exhaustion is?

A

right to register trademark, copyright and patent in the country hwere the product has been out on the market

22
Q

regional exhaustion is? (giv an e.g)

A

not limited in national border, it covers a specific region.
paten or trademark holder can not prohibits sales in national border or even specific region
e.g European free Trade associatio (EFTA) Europena Economic Area (EEA)

23
Q

inteernational exhaustion is?

A

paten, copyright or trademark world wide

24
Q

Direct savings are?

A

price difference between the importing country and similar prodcut from the low-price country (less costly product)

25
Q

indirect savings are?

A

price competition exerted n the market between orginal and parallel importer

26
Q

what is re-import?

A

product manufatured in coutry of orgin, packed in a low-price EU countries and re-imported back to the country of orgin

27
Q

Approval process is?

A

importer ha sto be a pharmaceutical enterprise, submission of the documents needed

28
Q

what is the specific mechanism?

A

it contain the declearation that eventhough the patent of a product is valid, it cannot block the import as the ptent is exhausted

29
Q

what does the importer has to do in case of a patent?

A

the importer need to inform the patenholder that they want to import it

30
Q

who decided in case of a patent?

A

the patenholder

31
Q

what are the necessary documents for the approval in importe products?

A

need a qualified person
submission of the pharmacovigilance system master file
need a manufacturing license for repackaging

32
Q

Advantages of parallel import?

A

high quality and safe medicines at a lower cost, increase trade between countries and possibility of alternative suppliers

33
Q

Conditional marketing authorisation ( Justifications)

A

Seriously debilitating diseases or life-threatening diseases

Medicinal products to be used in emergency situation.

Orphan medicinal products.

34
Q

Conditional marketing authorisation ( requirement))

A

The benefit-risk balance of the product is positive

It is likely that the applicant will be able to provide comprehensive data

Fulfillment of unmet medical need

The benefit to public health of the immediate availability on the market

35
Q

on what is the CMa based on?

A

less comprehensive scientific eveidence

36
Q

what are the specific oligations?

A

this are ongoing studies or conduction of new studies

pharmacovigilance studies

37
Q

why are SO needed?

A

to confirm the positive benefits of the MP still outweight the risk

38
Q

renewal of the CMA?

A

MMa apply for the renewal six months proir to its expiry
submission of a interim report
60 Assessement procedure

39
Q

what happend if the SO are fulfilled?

A

MA is no longer subjected to them, issued standar MA valid for 2 years

40
Q

how long is the CMA valid?

A

for one year and has to be reviewed annaully by the agency

41
Q

when is marketing authrisation under exceptional circumstances used?

A

insufficient data regarding safety and efficacy of the product, so that a normal application would not be possible.

42
Q

what are the requirement of MA under EC

A
  • Rare indication
  • Ethical Principles
  • Scientific knowledge
43
Q

what are SO for MA under EC?

A
  • Further studies must be completed within a time period specified by the authority to reassess the benefit/risk profile
  • Medical prescription and maybe also the administration only under strict medical supervision is mandatory
  • Medical information such as the package leaflet must provide a note on the (still) inadequacy of the information
44
Q

Justification of rare disease?

A

provide information on the epidemiological evidence to quantify the rarity of the disease

45
Q

Completion of dossier (CMA and MA under EC)

A

CMA: Expected to be complete post approval in a predetermined timeframe
MA under Ec:Not expected to be provided

46
Q

how long is MA under Ec valid?

A

Five years

47
Q

Reassessment/renewal (CMA and MA under EC)

A

CMA: Annual renewal till completion of dossier

MA under EC:Annual assessment of B/R balance

48
Q

Standard MA (CMA and MA under EC)

A

CMA: Granted on completion of comprehensive data

MA under EC: Remain MA under exceptional circumstance

49
Q

Application procedure (CMA and MA under EC)

A

CMA: Centralised Procedure

MA under EC: National, Decentralised and Centralised procedure.

Drug Regulatory Affairs (15 decks)

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