L12 Drug regulation in Singapore

Question 1

What is drug regulation?

Answer 1

• 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

Question 2

How is the drug regulation process relevant to the different stakeholders?

Answer 2

Slide 4

Question 3

What are the new clinical development in process of approving drugs?

Answer 3

• 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?

Question 4

How long does it take for a drug to be approved?

Answer 4

Slide 9

Question 5

What is the role of HSA?

Answer 5

Slide 11

Question 6

What is the legislative framework in Singapore?

Answer 6

Slide 12

Question 7

What kind of products require license and which does not?

Answer 7

Slide 13

Question 8

What is considered therapeutic products?

Answer 8

Slide 14

Question 9

What kind of drugs are regulated?

Answer 9

Slide 15

Question 10

What is the difference between generic and biosimilar drugs? and difference between new chemical entity and molecular entity?

Answer 10

Slide 15, 16

Question 11

For drugs that are not licensed by HSA, are there other regulations that they have to follow?

Answer 11

Slide 17

Question 12

What are the licenses needed to be registered by HSA?

Answer 12

Slide 18, 19, 20

Question 13

What is the purpose of the risk-calibrated evaluation?

Answer 13

Slide 22

Question 14

How is the risk-calibrated evaluation done?

Answer 14

Slide 23

Question 15

How is the benefit-risk evaluated? What criteria do they consider?

Answer 15

Slide 24, 26

Question 16

What criteria is evaluated for quality of new drugs?

Answer 16

Slide 28

Question 17

What is evaluated for safety of new drugs?

Answer 17

Slide 29

Question 18

What is evaluated for efficacy of new drugs?

Answer 18

Slide 30

Question 19

Are there any instances where approval needs to be expedited? What is done?

Answer 19

Slide 31

Question 20

How is the bridging between pre and post market done?

Answer 20

Slide 33

Question 21

How does HSA regulate/monitor the drug post market?

Answer 21

Slide 34, 35

Question 22

How does HSA decide if the drug is useful for the SG population (given it is a small market)? How does it outsource to other countries for information to evaluate the effectiveness?

Answer 22

Slide 36