30 Questions
How long does the pre-clinical studies phase typically last in drug development?
Approximately 4 years
In which phase of drug development are experiments conducted on patients numbering between 100-200?
Phase II
What is the estimated cost of researching and developing a new chemical or biological entity in euros according to the text?
€ 1,926 million
How many healthy subjects are typically involved in Phase I of drug development?
~20-80
During which phase in drug development does the EMA evaluation typically take place?
Phase III
Which phase of drug development involves patients ranging from 1000-3000 individuals?
Phase III
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
When can Scientific Advice (SA) be requested during drug development?
At any time point of development
What entities can be involved in parallel with the Scientific Advice procedure?
Health Technology Assessment (HTA) bodies
Is the scientific advice provided legally binding throughout the EU?
No, it is not legally binding
How long does it take for the Scientific Advice procedure to be finalized?
40 days maximum
What types of methodologies/biomarkers can be qualified through Scientific Advice?
Novel methodologies/biomarkers
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.
What is the characteristic of the legal basis in the context of strategic choices mentioned in the text?
Complete Biobliographic generic
What determines the fees in the Centralised Procedure according to the provided text?
One fee
Which procedure allows for adding new Member States as required, as discussed in the text?
Mutual Recognition Procedure
What aspect makes Centralised Procedure more efficient according to the text?
Capability to market throughout EU CP
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.
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)
When should specific questions be asked regarding Scientific Advice (SA)?
Avoid asking open questions
What was the average assessment time required for the centralized procedure in 2021?
394 days
Why is authorization of new medicines considered essential according to the text?
To provide new opportunities to treat certain diseases
When should interactions with regulators be established according to the text?
At major transition points in development
How many medicines were recommended for marketing authorization by EMA in 2021?
92 medicines
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
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
How often does the Scientific Advice Working Party (SAWP) meet throughout the year?
11 times
What is the basis for membership in the Scientific Advice Working Party (SAWP)?
Complimentary scientific expertise
Which regulatory bodies or organizations does the Scientific Advice Working Party (SAWP) interact with according to the text?
HTAs, WHO, patient organizations
What type of medicines receive significant benefit before the first marketing authorisation?
Orphan medicines
Test your knowledge on the scientific requirements for marketing authorisation (MA) both before and after the first MA. Learn about manufacturing, clinical trials, risk-management plans, generics, biosimilars, orphan medicines, extensions of indication, safety aspects, and more.
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