L13: Drug regulation

Question 1

what does SG regulate drugs after hitting the market? eg what approach?

Answer 1

Abridged method aka Risk-based approach
- depth of evaluation calibrated according to prior approvals
- reference agencies: FDA, EMA(EU), MHRA(UK), TGA (australian)

Question 2

what aspects does HSA evaluate? [4]

Answer 2

1. quality of both drug substance and drug product
   - checks manufacturing process, process validation, specifications, container closure system, stability
2. non-clinical data
   - toxicology and PKPD data in animal before we can proceed to human study
3. clinical data: efficacy and safety
   - inclusion/exclusion criteria, treatment, statistical methods, efficacy and safety analysis
4. ultimately do benefit-risk assessment
   - take into account ADRs, disease epidemiology and patient popn

Question 3

how does the SG govt react to emergency that poses threat to public health?

Answer 3

undergo Interim Authorisation and allows Rolling submission
- supply is directed by sg govt
- govt will consider is there reasonable evidence suggesting that potential benefits outweighs risks AND there will be continuing quality, safety and efficacy data generated from ongoing studies to support eventual transition into product registration

Question 4

what is rolling submission?

Answer 4

HSA start evaluating drug eg vaccine, from early stages of clinical trials aka concurrently as when companies submit real-time data ==> regulatory review concurrently

Question 5

how does SG do post-market monitoring?

Answer 5

1. have a risk management plan
   - have measures to mitigate potential risks associated w use of drug
   - active surveillance programmes
   -ADR reporting
   - dissemination of safety information to healthcare
   - product recall if necessary

Question 6

how does SG ensure transparency and predictability? [3]

Answer 6

1. publish information on website: product labels, legislation
2. communication w applicants: clarification of data during evaluation
3. stakeholder engagement: industry dialogue and consultation prior to implementation of new regulations