L12 Drug regulation in Singapore Flashcards
What is drug regulation?
- Ensure the quality, safety and efficacy of drugs sold in the country
- HSA/FDA
- Includes prescription drugs, OTC medicines, traditional medicines, health supplements
- Regulates clinical trials as well
- Submits an application containing detailed information about drug efficacy and safety, manufacturing processes and quality control (GMP) -> HSA reviews the application and conducts its own tests to ensure the drug meets safety and efficacy standards -> After post market surveillance, HSA continues to monitor the safety and efficacy + inspect facilities to ensure GMP
- Drug advertising also strictly regulated, must be truthful, balanced and not misleading
- Strict regulation in SG
How is the drug regulation process relevant to the different stakeholders?
Slide 4
What are the new clinical development in process of approving drugs?
- Slide 7, 8
- Animal testing not required? Would it still be safe?
- Reduced cost of drugs? Since pre-clinical on mouse is now not needed, reduction in cost for research?
- more ethical? animal rights?
How long does it take for a drug to be approved?
Slide 9
What is the role of HSA?
Slide 11
What is the legislative framework in Singapore?
Slide 12
What kind of products require license and which does not?
Slide 13
What is considered therapeutic products?
Slide 14
What kind of drugs are regulated?
Slide 15
What is the difference between generic and biosimilar drugs? and difference between new chemical entity and molecular entity?
Slide 15, 16
For drugs that are not licensed by HSA, are there other regulations that they have to follow?
Slide 17
What are the licenses needed to be registered by HSA?
Slide 18, 19, 20
What is the purpose of the risk-calibrated evaluation?
Slide 22
How is the risk-calibrated evaluation done?
Slide 23
How is the benefit-risk evaluated? What criteria do they consider?
Slide 24, 26