PV Assignment I

Regulatory Terminologies
Regulatory terminologies refer to specific terms and phrases used in the context of
regulations, compliance, and legal frameworks across various industries, such as finance,
healthcare, pharmaceuticals, and environmental management. These terminologies are
important for understanding and adhering to laws, guidelines, and standards set by
government bodies or regulatory agencies. Here are some common regulatory terms:
1. Regulation
A rule or directive made and maintained by an authority, typically governmental, to
manage specific behaviors, practices, or standards in a particular sector.
2. Compliance
Adherence to laws, regulations, guidelines, and specifications relevant to an organization’s
business or industry. Non-compliance can lead to legal penalties, including fines or other
sanctions.
3. FDA (Food and Drug Administration)

A regulatory body in the United States that oversees food safety, pharmaceuticals, medical
devices, and other consumer products.
4. GP
Refers to "Good Practice" standards in industries, particularly in pharmaceuticals and life
sciences. It includes:
-GMP: Good Manufacturing Practice
- GLP: Good Laboratory Practice
- GCP: Good Clinical Practice
5. CE Mark
A certification mark indicating conformity with health, safety, and environmental
protection standards for products sold within the European Economic Area (EEA).
6. HIPAA (Health Insurance Portability and Accountability Act)
A U.S. law that provides data privacy and security provisions for safeguarding medical
information.
7. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)
A European Union regulation aimed at improving the protection of human health and the
environment from the risks posed by chemicals.
8. ISO (International Organization for Standardization)

An international standard-setting body that develops and publishes a wide range of
proprietary, industrial, and commercial standards.
9. Audit
An official inspection or examination of an organization’s records, processes, and systems
to ensure compliance with regulatory standards.
10. Regulatory Affairs (RA)

A profession within industries like pharmaceuticals and medical devices that ensures
companies comply with all regulations and laws pertaining to their business.
11.Pharmacovigilance
The practice of monitoring the effects of medical drugs after they have been licensed for
use, especially to identify and assess adverse reactions.
12. Labeling Compliance

Ensuring that product labels meet the regulatory requirements of the country in which
they are sold, particularly in terms of ingredient lists, warnings, and usage instructions.
13. GDPR (General Data Protection Regulation)

A European Union law that governs data protection and privacy for individuals within the
EU and the European Economic Area.
14. Risk Management
The process of identifying, evaluating, and controlling risks, often required by regulatory
bodies, to minimize legal liability or health and safety hazards.
15. MHRA (Medicines and Healthcare products Regulatory Agency)

A regulatory body in the United Kingdom responsible for ensuring that medicines and
medical devices are safe and effective.
16. SOP (Standard Operating Procedure)

A set of step-by-step instructions compiled by an organization to help workers carry out
routine operations, ensuring compliance with industry standards and regulations.
17. Biocompatibility
The ability of a material to perform with an appropriate host response in a specific
situation, a critical concept in medical device regulation.
18. HACCP (Hazard Analysis and Critical Control Points)

A management system that addresses food safety by analyzing and controlling biological,
chemical, and physical hazards from raw material production to consumption.
19. Orphan Drug Designation
A status assigned to drugs developed for rare diseases, often providing regulatory and
financial incentives to the manufacturer.
20. Impact Assessment (EIA)
A process used to evaluate the environmental consequences of proposed developments or

projects before the decision-making process.

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Regulatory Terminologies

3. FDA (Food and Drug Administration)

-GMP: Good Manufacturing Practice

- GLP: Good Laboratory Practice

- GCP: Good Clinical Practice

7. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals)

8. ISO (International Organization for Standardization)

10. Regulatory Affairs (RA)

12. Labeling Compliance

13. GDPR (General Data Protection Regulation)

15. MHRA (Medicines and Healthcare products Regulatory Agency)

16. SOP (Standard Operating Procedure)

18. HACCP (Hazard Analysis and Critical Control Points)

19. Orphan Drug Designation

20. Impact Assessment (EIA)

A process used to evaluate the environmental consequences of proposed developments or

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