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EU Medical Device Regulations > EMA and Other Regulatory Bodies (Ch. 1) > Flashcards

EMA and Other Regulatory Bodies (Ch. 1) Flashcards

1
Q

What does EMA stand for?

A

EMA: European Medicines Agency

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2
Q

When was the EMA founded?

A 
The EMEA (European Medicines Evaluation Agency) was founded in 1995. 
(It changed names to EMA in 2009)
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3
Q

What is the primary function of the EMA?

A

To evaluate human and veterinary medicines

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4
Q

What does MAA stand for?

A

MAA: Marketing Authorisation Applications

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5
Q

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.

A

TRUE!

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6
Q

What does WHO stand for?

A

WHO: World Health Organization

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7
Q

What does ICH stand for?

A

ICH: International Council on Harmonization

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8
Q

What are the 4 components of the EMA’s mission?

A

EMA Mission:

  1. Facilitate development and access to medicines
  2. Evaluate applications for marketing authorization
  3. Monitor the safety of medicines across their lifecycles
  4. Provide information on human and veterinary medicines to healthcare professionals and patients
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9
Q

What is the PRIME scheme?

A

PRIME: Priority Medicines scheme - to enhance support for developing medicines that target unmet medical needs

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10
Q

What does STAMP stand for?

A

STAMP:
Safe and Timely Access to Medicines for Patients
- an EC expert group

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11
Q

What is SAWP?

A

SAWP: Scientific Advice Working Party

- provides scientific advice and protocol assistance for human medicines

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12
Q

What is a result of the EU Pediatric Regulation?

A

Allows the EMA to stimulate research into medicines use in children

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13
Q

What is a PIP?

A

PIP: Pediatric Investigation Plans

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14
Q

What is ATMPs?

A

ATMP: Advanced Therapy Medicinal Products

- based on genes or cells

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15
Q

What is the ITF?

A

ITF: Innovation Task Force
- a multi-disciplinary group with the goal to nurture research and innovative methods in developing medicines in a timely fashion

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16
Q

What is the EEA?

A

EEA: European Economic Area

17
Q

What countries are part of the EEA?

A

EU countries + Iceland, Liechtenstein, and Norway

18
Q

What is a centralised procedure?

A

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.

19
Q

What is the HMA?

A

HMA: Heads of Medicines Agencies

- a network of the heads of the national competent authorities (EEA)

20
Q

What is the purpose of EMA committees?

A

Evaluate medicines throughout their lifecycles, from development to marketing authorization to pharmacovigilance monitoring; evaluate MAAs

21
Q

What is CHMP?

A

CHMP: Committee for Medicinal Products for Human Use

- authorizes human medicines

22
Q

What is PRAC?

A

PRAC: Pharmacovigilance Risk Assessment Committee

- Responsible for assessing and monitoring human medicinal products’ safety and assessing risk management

23
Q

What is CVMP?

A

CVMP: Committee for Medicinal Products for Veterinary Use

- authorizes veterinary medicines

24
Q

What is COMP?

A

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)

25
Q

What is HMPC?

A

HMPC: Committee on Herbal Medicinal Products

- Compile and assess scientific data on herbal substances, preparations and combinations

26
Q

What is CAT?

A

CAT: Committee for Advanced Therapies

- Prepare a draft opinion on each ATMP application submitted to EMA

27
Q

What is PDCO?

A

PDCO: Pediatric Committee

- Responsible for activities on medicines for children and supporting such medicines’ development

28
Q

What is CMDh?

A

CMDh: The Coordination Group for Mutual Recognition and Decentralized Procedures - Human

29
Q

What is CMDv?

A

CMDv: The Coordination Group for Mutual Recognition and Decentralized Procedures - Veterinary

30
Q

What is the benefit of international cooperation?

A

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

31
Q

What is Brexit?

A

Brexit: The UK formally left the EU on Jan. 31, 2020 and became a third country. The UK is currently in a transition period.

EU Medical Device Regulations (15 decks)

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