Ch. 1: Introduction to International Regulatory Affairs

Question 1

Regulations vary greatly by region. What factors affect medical device regulations?

Answer 1

The product’s risk profile, the maturity of the regulatory system

Question 2

What is the main intent of drug/medical device regulators?

Answer 2

To protect public health

Question 3

What is the WHO?

Answer 3

WHO: World Health Organization (1948)

• An agency of the UN - United Nations
• to provide global leadership in the area of public health

Question 4

What is the ICH?

Answer 4

ICH: International Council on Harmonization (1990)

- Aims to make recommendations toward achieving greater harmonization

Question 5

What is STED?

Answer 5

STED: Summary Technical Documentation
- a harmonized submission format
(developed by GHTF)

Question 6

What is the GHTF?

Answer 6

GHTF: Global Harmonization Task Force (1992-2012)

- to achieve greater uniformity between national medical device regulatory systems

Question 7

What is the IMDRF?

Answer 7

IMDRF: International Medical Device Regulatory Forum (2011)

- replaced the GHTF, medical device regulators only

Question 8

What is the NCAR Exchange Program?

Answer 8

National Competent Authority Report (NCAR) Exchange Program

- developed for exchanging adverse event information

Question 9

What is the PIC/S?

Answer 9

PIC/S: The Pharmaceutical Inspection Co-operation Scheme (1995)
- informal arrangement between regulatory authorities regarding GMPs

Question 10

What is MDSAP?

Answer 10

MDSAP: Medical Device Single Audit Program

- developed by the IMDRF, by MDSAP Regulatory Authority Council

Question 11

What is the VICH?

Answer 11

VICH: International Harmonization on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (1996)

Question 12

What is the IPRF?

Answer 12

IPRF: International Pharmaceutical Regulators Forum

- facilitates implementation of ICH and other internationally harmonized technical guidelines

Question 13

What is ASEAN?

Answer 13

ASEAN: Association of Southeast Asian Nations (1967)

Question 14

What is ASEAN PPWG?

Answer 14

ASEAN PPWG: Pharmaceutical Product Working Group (1999)

- to develop harmonization schemes of pharmaceutical regulations in ASEAN countries

Question 15

What is APEC?

Answer 15

APEC: Asian-Pacific Economic Cooperation (1989)

- economic growth

Question 16

What is APEC LSIF?

Answer 16

APEC LSIF: Life Sciences Innovation Forum (2002)

- to lead health sciences innovation

Question 17

What is the APEC LSIF RHSC?

Answer 17

APEC LSIF RHSC: Regulatory Harmonization Steering Committee (2013)
- regional convergence on regulatory approval procedures

Question 18

What is AHWP?

Answer 18

AHWP: Asian Harmonization Working Party (1996)

- transitioning to the GHWP (Global)

Question 19

What is the EAEU?

Answer 19

EAEU: Eurasian Economic Union (2014)

- Russia

Question 20

What is PANDRH?

Answer 20

PANDRH: Pan American Network for Drug Regulatory Harmonization (1999)
- drug regulatory harmonization

Question 21

What is AMRH?

Answer 21

AMRH: African Medicines Regulatory Harmonization (2014)

- establish and improve medical standards in Africa

Question 22

What is ECOWAS?

Answer 22

ECOWAS: Economic Community of West African States (1975)

- promote economic integration

Question 23

What is ICMRA?

Answer 23

ICMRA: International Coalition of Medicines Regulatory Authorities
- to address emerging regulatory and safety challenges globally

Question 24

What is IPRP?

Answer 24

IPRP: International Pharmaceutical Regulators Program (2018)
- exchange info on regulatory approaches

Question 25

What is the OECD?

Answer 25

OECD: Organization for Economic Cooperation and Development (1961)
- establishes international standards

Question 26

What is OIC?

Answer 26

OIC: Organization of Islamic Cooperation (1969)