Global Glossary

Question 1

Accelerated Assessment

Answer 1

A marketing authorization procedure designed to meet, in particular, patients’ legitimate expectations and take into account the increasingly rapid progress of science and therapies, for medicinal products of major interest from the point of view of public health and in particular from the view point of therapeutic innovation. (EU)

Question 2

Adulterated

Answer 2

Product containing any filthy, putrid or decomposed substance; or prepared under unsanitary conditions; or not made according to GMPs; or containing an unsafe color additive; or not meeting the requirements of an official compendium.

Question 3

ACTD

Answer 3

ASEAN Common Technical Dossier

Question 4

AHWP

Answer 4

Asian Harmonization Working Party

Question 5

AIMD

Answer 5

Active Implantable Medical Device

Question 6

ALCOA

Answer 6

Acronym for key attributes for source documents: attributable, legible, contemporaneous, original and accurate

Question 7

AMRH

Answer 7

African Medicines Regulatory Harmonization

Question 8

Animal Rule

Answer 8

Allows FDA to approve a product for which evidence of
safety and efficacy has been based on data obtained in adequate and well-controlled animal trials. Primarily intended for products that might be unsafe for testing on healthy humans. (US)

Question 9

Annual Report

Answer 9

An annual periodic report or progress report that must be
submitted to FDA. It must include new safety, efficacy and labeling information; preclinical and clinical investigation
summaries; CMC updates; nonclinical laboratory studies;
and completed unpublished clinical trials. (US)

Question 10

ANSI

Answer 10

American National Standards Institute

Question 11

APEC

Answer 11

Asian-Pacific Economic Cooperation

Question 12

ASEAN

Answer 12

Association of Southeast Asian Nations. Comprised of
Brunei Darussalam, Cambodia, Indonesia, Lao PDR,
Malaysia, Myanmar, Philippines, Singapore, Thailand and
Vietnam.

Question 13

CADTH

Answer 13

Canadian Agency for Drugs and Technologies in Health

Question 14

CAPA

Answer 14

Corrective and Preventive Action

Question 15

CDRH

Answer 15

Center for Devices and Radiological Health (FDA)

Question 16

CE Mark

Answer 16

Indicates product conforms with essential health and safety requirements. (EU)

Question 17

CEN

Answer 17

European Committee for Standardisation

Question 18

CFDA

Answer 18

China Food and Drug Administration

Question 19

CFR

Answer 19

Code of Federal Regulations (US)

Question 20

CIS

Answer 20

Confederation of Independent States, comprised of
Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan,
Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan,
Ukraine and Uzbekistan.

Question 21

CMC

Answer 21

Chemistry, manufacturing and controls

Question 22

Company Core Data Sheet

Answer 22

(CCDS) Includes product information relating to safety,

indications, dosing, pharmacology and other information.

Question 23

Company Core Safety Information

Answer 23

(CCSI) Contains the core safety data about the product
that is required to be on the product’s label in each country. This safety information is obtained from worldwide case reporting and screening of all product safety information.

Question 24

Competent authority

Answer 24

A competent authority is the national governmental authority responsible for the authorization and supervision of medicinal products.

Question 25

Conformity assessment

Answer 25

A procedure to enable public authorities to ensure industrial products, including medical devices, placed on the market conform to the requirements as expressed in the provisions of the directives, particularly regarding the health and safety of users and consumers.

Question 26

Crisis management plan

Answer 26

Comprises various methods to respond to a crisis and establish metrics to deal with crises, including defining what scenarios constitute a crisis and possible response mechanisms. A crisis management plan should include possible worst-case scenarios and solutions in the form of a contingency plan.

Question 27

Decentralised Procedure

Answer 27

Procedure that may be used for medicinal products for which there is no existing Marketing Authorisation in any EU Member State. The applicant can select the Reference Member State and list the Concerned Member States.

Question 28

Declaration of Conformity

Answer 28

A document whereby the manufacturer ensures that either the product safety component satisfies the essential requirements of the applicable directives or the product is in conformity with the type for which a type-examination certificate has been issued and satisfies the essential requirements of the applicable directives. (EU)

Question 29

Directive

Answer 29

An EC decision that is binding on EC institutions and Member States and must be transposed into national legislation. However, the way in which it is implemented is left to the discretion of each Member State. (EU)

Question 30

DMAH

Answer 30

Designated Marketing Authorization Holder (Japan)

Question 31

EP checklist

Answer 31

A list of Essential Principles indicating their applicability to a particular device and justification for those not considered to be applicable.

Question 32

ERA

Answer 32

Environmental Risk Assessment

Question 33

Essential Requirements

Answer 33

The technical requirements with which a medical device | must comply in order to be CE marked.

Question 34

EU IVDR

Answer 34

New EU regulation for in vitro diagnostic devices. Revises | the EU’s current IVD Directive (98/79/EC).

Question 35

EU MDR

Answer 35

New EU regulation for medical devices. Revises the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

Question 36

European Union

Answer 36

(EU) The EU is composed of 28 Member States (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the UK).

Question 37

EFTA

Answer 37

European Free Trade Association, composed of Iceland, | Liechtenstein, Norway and Switzerland.

Question 38

F&DA

Answer 38

Food and Drugs Act. Primary law governing medical products in Canada.

Question 39

F&EC

Answer 39

Facility and equipment controls

Question 40

FD&C Act

Answer 40

Food, Drug, and Cosmetic Act. Primary law governing | healthcare products in the US.

Question 41

Field Safety Corrective Action

Answer 41

(FSCA) An action taken by a manufacturer to reduce the risk of death or serious deterioration in the state of health associated with the use of a medical device.

Question 42

Field Safety Notice

Answer 42

(FSN) A communication to customers and/or users sent out by a manufacturer or its representative in relation to a Field Safety Corrective Action.

Question 43

FMA

Answer 43

Foreign Manufacturing Authorization (Japan)

Question 44

FMEA

Answer 44

Failure Mode Effects Analysis

Question 45

GCP

Answer 45

Good Clinical Practice

Question 46

GDP

Answer 46

Good Documentation Practice

Question 47

GLP

Answer 47

Good Laboratory Practice

Question 48

GMP

Answer 48

Good Manufacturing Practice

Question 49

Hatch-Waxman Act

Answer 49

Enacted in 1984, this act forms the basis for generic drug | approval in the US

Question 50

Health Canada

Answer 50

Primary regulatory body for medicinal products in Canada

Question 51

HIPAA

Answer 51

Health Insurance Portability & Accountability Act (US)

Question 52

ICF

Answer 52

Informed Consent Form

Question 53

ICH

Answer 53

International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (participants include the EU, US, Japan, Canada and Switzerland)