L12 Drug regulation in Singapore Flashcards

1
Q

What is drug regulation?

A
  • 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
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2
Q

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

A

Slide 4

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3
Q

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

A
  • 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?
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4
Q

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

A

Slide 9

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5
Q

What is the role of HSA?

A

Slide 11

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6
Q

What is the legislative framework in Singapore?

A

Slide 12

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7
Q

What kind of products require license and which does not?

A

Slide 13

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8
Q

What is considered therapeutic products?

A

Slide 14

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9
Q

What kind of drugs are regulated?

A

Slide 15

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10
Q

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

A

Slide 15, 16

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11
Q

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

A

Slide 17

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12
Q

What are the licenses needed to be registered by HSA?

A

Slide 18, 19, 20

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13
Q

What is the purpose of the risk-calibrated evaluation?

A

Slide 22

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14
Q

How is the risk-calibrated evaluation done?

A

Slide 23

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15
Q

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

A

Slide 24, 26

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16
Q

What criteria is evaluated for quality of new drugs?

A

Slide 28

17
Q

What is evaluated for safety of new drugs?

A

Slide 29

18
Q

What is evaluated for efficacy of new drugs?

A

Slide 30

19
Q

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

A

Slide 31

20
Q

How is the bridging between pre and post market done?

A

Slide 33

21
Q

How does HSA regulate/monitor the drug post market?

A

Slide 34, 35

22
Q

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?

A

Slide 36