Scientific Requirements for Marketing Authorisation Quiz

Play an AI-generated podcast conversation about this lesson

How long does the pre-clinical studies phase typically last in drug development?

Approximately 8 years

Approximately 4 years (correct)

Approximately 6 years

Approximately 2 years

In which phase of drug development are experiments conducted on patients numbering between 100-200?

Phase II (correct)

Phase I

Phase III

Pre-clinical studies

What is the estimated cost of researching and developing a new chemical or biological entity in euros according to the text?

€ 4,000 million

€ 3,000 million

€ 1,926 million (correct)

€ 2,558 million

How many healthy subjects are typically involved in Phase I of drug development?

~20-80 Signup and view all the answers

During which phase in drug development does the EMA evaluation typically take place?

Phase III Signup and view all the answers

Which phase of drug development involves patients ranging from 1000-3000 individuals?

Phase III Signup and view all the answers

What is the purpose of the Scientific Advice (SA) procedure mentioned in the text?

To determine positive benefit/risk during the Marketing Authorization Application (MAA) process Signup and view all the answers

When can Scientific Advice (SA) be requested during drug development?

At any time point of development Signup and view all the answers

What entities can be involved in parallel with the Scientific Advice procedure?

Health Technology Assessment (HTA) bodies Signup and view all the answers

Is the scientific advice provided legally binding throughout the EU?

No, it is not legally binding Signup and view all the answers

How long does it take for the Scientific Advice procedure to be finalized?

40 days maximum Signup and view all the answers

What types of methodologies/biomarkers can be qualified through Scientific Advice?

Novel methodologies/biomarkers Signup and view all the answers

What is the key difference between conditional approval and approval under exceptional circumstances?

Conditional approval is valid for one year, while approval under exceptional circumstances involves annual review. Signup and view all the answers

What is the characteristic of the legal basis in the context of strategic choices mentioned in the text?

Complete Biobliographic generic Signup and view all the answers

What determines the fees in the Centralised Procedure according to the provided text?

One fee Signup and view all the answers

Which procedure allows for adding new Member States as required, as discussed in the text?

Mutual Recognition Procedure Signup and view all the answers

What aspect makes Centralised Procedure more efficient according to the text?

Capability to market throughout EU CP Signup and view all the answers

In what way does Approval under exceptional circumstances differ from Conditional approval based on the text?

'Approval under exceptional circumstances' will not lead to normal marketing authorization, while 'Conditional approval' can become normal marketing authorization. Signup and view all the answers

What is the purpose of encouraging Scientific Advice (SA) early in development or at major transition points?

To enhance the probability of successful marketing authorization application (MAA) Signup and view all the answers

When should specific questions be asked regarding Scientific Advice (SA)?

Avoid asking open questions Signup and view all the answers

What was the average assessment time required for the centralized procedure in 2021?

394 days Signup and view all the answers

Why is authorization of new medicines considered essential according to the text?

To provide new opportunities to treat certain diseases Signup and view all the answers

When should interactions with regulators be established according to the text?

At major transition points in development Signup and view all the answers

How many medicines were recommended for marketing authorization by EMA in 2021?

92 medicines Signup and view all the answers

What types of questions do companies typically ask before the first marketing authorisation (MA)?

Questions related to manufacturing, non-clinical and clinical trials, risk-management plans, generics development, and orphan medicines Signup and view all the answers

What is the primary focus of Scientific Advice given by the Committee for Medicinal Products for Human Use (CHMP)?

Developing strategies for future medicine development Signup and view all the answers

How often does the Scientific Advice Working Party (SAWP) meet throughout the year?

What is the basis for membership in the Scientific Advice Working Party (SAWP)?

Complimentary scientific expertise Signup and view all the answers

Which regulatory bodies or organizations does the Scientific Advice Working Party (SAWP) interact with according to the text?

HTAs, WHO, patient organizations Signup and view all the answers

What type of medicines receive significant benefit before the first marketing authorisation?

Orphan medicines Signup and view all the answers