Drug Regulation

Question 1

Pure Food and Drug Act

Answer 1

1906, US.

Correct labeling of ingredients and their quantities.

Question 2

Food, Drug and Cosmetic Act

Answer 2

1938, US.
Pre-market safety testing, def. of drug and misleading advertising.
But: no definition of safety, default approval, no evidence for efficacy required.

Question 3

Kefauver-Harris Amendment

Answer 3

1962, US.

FDA approval and evidence for effectiveness from trials required, report of adverse reactions, consent in studies.

Question 4

Sulfanilamide tragedy

Answer 4

First commercially used antibacterial drug. Sold as syrup. Solvent: Diethylene glycol (toxic). Children died of kidney failure.
Consequence: federal food, drug and cosmetic act of 1938

Question 5

History of drug regulation in Ger

Answer 5

20s/30s: first drafts
1961: first drug law
1964: amendments (studies)
1957-61: Contergan scandal
1976: new drug regulation law

Question 6

German drug regulator law regulates:

Answer 6

drug def and requirements, labeling, manufacturing, distribution, trial safety, approval requirements, generic drug approval, surveillance for adverse effects (pharmacovigilance)
No approval required for homeopathic/herbal medicine

Question 7

BfArM (federal institute for drugs and medical devices)

Answer 7

Founded in 1994 after HIV in blood donations. Bonn.

Approval of new drugs (small-molecule), evaluation of risks, regulation of controlled substances (drugs).

Question 8

Paul-Ehrlich-Institut

Answer 8

German federal institute for vaccines and biomedicines. Langen. Founded in 1896.
Evaluate safety/provide approval for vaccines, biomedicines, allergens for therapy and diagnostics, antibodies, blood, tissue products.

Question 9

European Medicines Agency (EMA)

Answer 9

EU agency for drug evaluation. Founded 1995. Amsterdam.
Evaluates new drug application (approval is granted by Eu commission).
Compulsory for biotech/antiviral/orphan drugs and drugs against HIV/cancer/diabetes/neurodegenerative disorders/autoimmune-diseases.

Question 10

Food and Drug Administration

Answer 10

US agency for drug evaluation. Founded 1906. White Oak.

Safety of drugs, medicinal devices, vaccines/biomedicines/blood transfusion, food, cosmetics, etc

Question 11

Approval processes in EU

Answer 11

1. Limited to one country
2. For entire EU (required for some)
3. Mutual recognition (approval in one country accepted by others)