Regulatory Bodies
THIS AGENCY IN THE UNITED STATES OVERSEES THE REGULATION OF FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES.
FOOD AND DRUG ADMINISTRATION
A TERM DESCRIBING THE PROCESS OF TESTING DRUGS FOR SAFETY AND EFFICACY BEFORE THEY CAN BE MARKETED.
THE PROCESS OF INVOLVING PEOPLE IN HEALTHCARE DECISION-MAKING AND TREATMENT PLANNING.
PATIENT ENGAGEMENT
THIS COUNTRY HAS THE NATIONAL HEALTH SERVICE (NHS) THAT GIVES FREE HEALTHCARE TO EVERYONE.
UNITED KINGDOM
THIS GROUP OF COUNTRIES WORKS TOGETHER TO MAKE SURE FOOD AND TOYS ARE SAFE FOR KIDS.
THE EUROPEAN UNION
RESPONSIBLE FOR REGULATING MEDICAL PRODUCTS IN JAPAN, THIS AGENCY ENSURES SAFETY AND EFFICACY STANDARDS ARE MET
PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA)
DRUGS MADE BY MULTIPLE MANUFACTURERS AFTER THE PATENT EXPIRATION OF A BRAND-NAME DRUG
GENERIC DRUGS
PLATFORMS OR PROGRAMS ALLOWING PATIENTS TO ACCESS THEIR HEALTH RECORDS AND COMMUNICATE WITH HEALTHCARE PROVIDERS
PATIENT PORTALS
THIS COUNTRY INTRODUCED "OBAMACARE" IN 2012 TO HELP MORE PEOPLE GET HEALTH INSURANCE
THE UNITED STATES OF AMERICA
THIS COUNTRY HAS RULES THAT MAKE SURE EVERYONE CAN SEE A DOCTOR WITHOUT PAYING A LOT OF MONEY
SWEDEN
THE EUROPEAN UNION'S REGULATORY BODY FOR DRUGS, ENSURING THEIR SAFETY AND EFFICACY
EUROPEAN MEDICINES AGENCY (EMA)
THE CHEMICAL OR ACTIVE INGREDIENT IN A DRUG THAT PRODUCES THE INTENDED EFFECT
ACTIVE PHARMACEUTICAL INGREDIENT (API)?
This approach encourages patients to take an active role in managing their own health.
patient empowerment
A tool or strategy used to gather feedback from patients about their healthcare experiences
patient satisfaction survey
An organization advocating for the rights and interests of patients in healthcare policy and decision-making.
patient advocacy group
This organization collaborates with individual countries in Europe to regulate medical devices.
Medical Device Coordination Group (MDCG)
A regulatory term for drugs not yet approved for general use but allowed for use in specific cases.
investigational/ test drugs
A tool or strategy used to gather feedback from patients about their healthcare experiences.
patient satisfaction survey
A policy that prohibits discrimination against individuals with disabilities in all areas of public life.
Americans with Disabilities Act/ European Accessibility Act
An international agreement aimed at improving the safety, efficacy, and quality of pharmaceuticals.
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Oversees the regulation of medical devices in Canada.
Health Canada's Medical Devices Bureau
A comprehensive document submitted to regulatory agencies detailing the safety and efficacy of a drug
New Drug Application (NDA) or Marketing Authorization Application (MAA)
An organization advocating for the rights and interests of patients in healthcare policy and decision-making.
patient advocacy group
Legislation enacted to protect the privacy and security of health information.
Health Insurance Portability and Accountability Act (HIPAA)/ Global Data Protection Regulation (GDPR)
This organization coordinates the regulation of medicines across multiple countries.
World Health Organization (WHO)