EMA and Other Regulatory Bodies (Ch. 1) Flashcards
What does EMA stand for?
EMA: European Medicines Agency
When was the EMA founded?
The EMEA (European Medicines Evaluation Agency) was founded in 1995. (It changed names to EMA in 2009)
What is the primary function of the EMA?
To evaluate human and veterinary medicines
What does MAA stand for?
MAA: Marketing Authorisation Applications
True/False: The EMA plays a key role in supporting medicine’s approval, pharmaceutical research and innovation, and promoting the development of innovative novel medicines.
TRUE!
What does WHO stand for?
WHO: World Health Organization
What does ICH stand for?
ICH: International Council on Harmonization
What are the 4 components of the EMA’s mission?
EMA Mission:
- Facilitate development and access to medicines
- Evaluate applications for marketing authorization
- Monitor the safety of medicines across their lifecycles
- Provide information on human and veterinary medicines to healthcare professionals and patients
What is the PRIME scheme?
PRIME: Priority Medicines scheme - to enhance support for developing medicines that target unmet medical needs
What does STAMP stand for?
STAMP:
Safe and Timely Access to Medicines for Patients
- an EC expert group
What is SAWP?
SAWP: Scientific Advice Working Party
- provides scientific advice and protocol assistance for human medicines
What is a result of the EU Pediatric Regulation?
Allows the EMA to stimulate research into medicines use in children
What is a PIP?
PIP: Pediatric Investigation Plans
What is ATMPs?
ATMP: Advanced Therapy Medicinal Products
- based on genes or cells
What is the ITF?
ITF: Innovation Task Force
- a multi-disciplinary group with the goal to nurture research and innovative methods in developing medicines in a timely fashion
What is the EEA?
EEA: European Economic Area
What countries are part of the EEA?
EU countries + Iceland, Liechtenstein, and Norway
What is a centralised procedure?
A European authorisation route resulting in a centrally authorised product with a single Marketing Authorisation. If a product has been authorised using the centralised procedure it has been assessed on an EU wide basis and approved by the European Commission.
What is the HMA?
HMA: Heads of Medicines Agencies
- a network of the heads of the national competent authorities (EEA)
What is the purpose of EMA committees?
Evaluate medicines throughout their lifecycles, from development to marketing authorization to pharmacovigilance monitoring; evaluate MAAs
What is CHMP?
CHMP: Committee for Medicinal Products for Human Use
- authorizes human medicines
What is PRAC?
PRAC: Pharmacovigilance Risk Assessment Committee
- Responsible for assessing and monitoring human medicinal products’ safety and assessing risk management
What is CVMP?
CVMP: Committee for Medicinal Products for Veterinary Use
- authorizes veterinary medicines
What is COMP?
COMP: Committee for Orphan Medicinal Products
- Evaluate applications for orphan designation (designation for medicines developed for the diagnosis, prevention, or treatment of rare diseases that are life-threatening or very serious)
What is HMPC?
HMPC: Committee on Herbal Medicinal Products
- Compile and assess scientific data on herbal substances, preparations and combinations
What is CAT?
CAT: Committee for Advanced Therapies
- Prepare a draft opinion on each ATMP application submitted to EMA
What is PDCO?
PDCO: Pediatric Committee
- Responsible for activities on medicines for children and supporting such medicines’ development
What is CMDh?
CMDh: The Coordination Group for Mutual Recognition and Decentralized Procedures - Human
What is CMDv?
CMDv: The Coordination Group for Mutual Recognition and Decentralized Procedures - Veterinary
What is the benefit of international cooperation?
Protects product quality and supply chain security, ensures data integrity to support clinical trails and manufacturing, encourages a global approach to authorization, effective use of global regulatory resources
What is Brexit?
Brexit: The UK formally left the EU on Jan. 31, 2020 and became a third country. The UK is currently in a transition period.
