Podcast
Questions and Answers
Who is the authorising body for all centrally-authorised products in the EU?
Who is the authorising body for all centrally-authorised products in the EU?
- European Commission (correct)
- EMA
- European Medicines Agency
- European Parliament
What is the role of the European Medicines Agency (EMA) in the marketing authorization process?
What is the role of the European Medicines Agency (EMA) in the marketing authorization process?
- Grants EU-wide marketing authorisation
- Oversees pricing and reimbursement decisions
- Makes the final decision on marketing authorization
- Formulates scientific opinions and recommendations (correct)
When does the European Commission issue its final legally binding decision on marketing authorization?
When does the European Commission issue its final legally binding decision on marketing authorization?
- Within 120 days of initial assessment
- After clock stop 2 at day 210
- 67 days after receipt of EMA's recommendation (correct)
- Once EMA completes further consultations
What role does the European Commission play in decisions on patient access to medicines?
What role does the European Commission play in decisions on patient access to medicines?
Who takes the final legally binding decision on whether a medicine can be marketed in the EU?
Who takes the final legally binding decision on whether a medicine can be marketed in the EU?
What happens after EMA sends its scientific opinions and recommendations to the European Commission?
What happens after EMA sends its scientific opinions and recommendations to the European Commission?
What is the main responsibility of the European Medicines Agency (EMA) according to the text?
What is the main responsibility of the European Medicines Agency (EMA) according to the text?
What happens following the centralized procedure for marketing authorizations?
What happens following the centralized procedure for marketing authorizations?
In what way does the EMA contribute to public health according to the text?
In what way does the EMA contribute to public health according to the text?
What does the EMA do once granted with centralised marketing authorisation applications?
What does the EMA do once granted with centralised marketing authorisation applications?
Which organization is involved in the process of cooperation with other EU institutions and Agencies according to the text?
Which organization is involved in the process of cooperation with other EU institutions and Agencies according to the text?
What is the responsibility of EMA regarding antibiotic resistance according to the text?
What is the responsibility of EMA regarding antibiotic resistance according to the text?
What are the main principles that the European Medicines Agency (EMA) verifies compliance with?
What are the main principles that the European Medicines Agency (EMA) verifies compliance with?
In addition to GMP, GCP, GLP, and GVP, what other aspects of supervision do inspections by EMA verify compliance with?
In addition to GMP, GCP, GLP, and GVP, what other aspects of supervision do inspections by EMA verify compliance with?
Which regulations specify the roles and responsibilities of EMA in ensuring compliance with various practices?
Which regulations specify the roles and responsibilities of EMA in ensuring compliance with various practices?
What is the main objective of the sampling and testing programme implemented by EMA?
What is the main objective of the sampling and testing programme implemented by EMA?
What does the sampling and testing programme specifically involve according to the text?
What does the sampling and testing programme specifically involve according to the text?
Apart from monitoring quality through the distribution chain, what else does the sampling and testing programme assist with?
Apart from monitoring quality through the distribution chain, what else does the sampling and testing programme assist with?
Study Notes
European Medicines Agency (EMA)
- Provides scientific opinions on medicines
- Responsible for protecting and promoting public and animal health by evaluating medicines for human and veterinary use
Centralised Marketing Authorisation
- Covers all European Union (EU) Member States, Iceland, Norway, and Liechtenstein
- Valid after grant by the European Commission
- Includes evaluation of marketing authorisation applications (MAA)
Steps in Centralised Procedure
- Initial assessment and list of questions (by day 120)
- Clock stop 1: Further assessment and list of outstanding issues (by day 180)
- Clock stop 2: Further consultations (by day 210)
- Final discussion and adoption of opinion
- Possible re-examination
EMA's Role
- Recommends to the European Commission on marketing authorisation
- Supervises safety of medicines in the EU after authorisation
- Monitors safety of medicines across their lifecycle
- Provides scientific opinions on medicines at request of Member States or the European Commission
Decisions on Patient Access to Medicines
- Decisions made at national and regional level on pricing and reimbursement
- EMA has no role in decisions on pricing and reimbursement
EMA's Inspections
- Coordinates inspections to verify compliance with good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), and good pharmacovigilance practice (GVP)
- Verifies compliance with other aspects of supervision of authorised medicinal products in use in the EU
Sampling and Testing
- Supervises quality of centrally authorised medicines available on the European market through yearly sampling and testing programme
- Checks compliance of products on the market with authorised specifications
- Monitors quality of finished products in all parts of the distribution chain throughout the authorised shelf-life
- Ensures control methods are satisfactory
- Investigates suspected quality defects (if required)
- Assists with testing of falsified medicines (if required)
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Description
Learn about the European Medicines Agency's responsibilities, including scientific opinions, marketing authorisations, and cooperation with other EU institutions and global health organizations like WHO.EMA.
