Q12. What is considered a drug, according to Health Canada? Who reviews drugs fo
ID: 96162 • Letter: Q
Question
Q12. What is considered a drug, according to Health Canada? Who reviews drugs for safety, efficacy, and quality?
Q13. When did the European Commission harmonize the rules relating to medical devices, and what devices did the three resulting directives cover?
Q14. In the US Food and Drug Administration (USFDA), how many Centers are there in the Office of Medical Products and Tobacco? Which Centers focus on medical devices, biologics, and drugs?
Q15. How many Offices are there in CBER? Do any of the Offices focus on medical devices or biologics?
Q16. What is the Code of Federal Regulations? Which title covers the Food and Drug Administration (FDA)?
Q17. What must each person engaged in the manufacture, processing, packaging, or holding of a drug product have? And what are these people’s responsibilities?
Explanation / Answer
Q12. What is considered a drug, according to Health Canada? Who reviews drugs for safety, efficacy, and quality?
According to the Food and Drugs Act, "a drug includes any substance or mixture of substances manufactured, sold or represented for use in:
a. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
b. restoring, correcting or modifying organic functions in human beings or animals; or
c. disinfection in premises in which food is manufactured, prepared or kept."
The drugs are reviewed by scientists in the Health Products and Food Branch (HPFB) of Health Canada.
Q13. When did the European Commission harmonize the rules relating to medical devices, and what devices did the three resulting directives cover?
The classification rules were set out in Annex IX of Directive 93/42/EEC. They correspond, to a large extent, to the classification rules established by the Global Harmonization Task Force (GHTF) in the guidance document GHTF/SG1/N15:2006.
Active implantable and in vitro diagnostic medical devices are covered by separate directives.
Q14. In the US Food and Drug Administration (USFDA), how many Centers are there in the Office of Medical Products and Tobacco? Which Centers focus on medical devices, biologics, and drugs?
•Center for Drug Evaluation and Research
•Center for Biologics Evaluation and Research
•Center for Devices and Radiological Health
•Center for Tobacco Products
•Oncology Center of Excellence
•Office of Special Medical Programs.
The Center for Biologics Evaluation and Research (CBER) is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.
Q15. How many Offices are there in CBER? Do any of the Offices focus on medical devices or biologics?
The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. There are 7 centers in CBER and the Center for Biologics Evaluation and Research focuses on medical devices or biologics.
Q16. What is the Code of Federal Regulations? Which title covers the Food and Drug Administration (FDA)?
Code of Federal Regulations is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the federal government of the United States.
Title 21 of the Code of Federal Regulations governs food and drugs within the United States for the Food and Drug Administration (FDA).
Q17. What must each person engaged in the manufacture, processing, packaging, or holding of a drug product have? And what are these people’s responsibilities?
Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.
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