Drug Development & Regulation

Question 1

Describe the pathway of drug development?

Answer 1

Discovery
-	Finding lead molecules
Development
-	Pre-clinical pharmacology and toxicology
-	Clinical trials
Regulation
-	Registration – TGA Approval
-	Reimbursement – PBS Approval

Question 2

Outline the ethical considerations for researchers using animals.

Answer 2

Animal Ethics

• Projects using animals may be performed only after a decision has been made that they are justified.
• Weighing the predicted scientific or educational value of the project against the potential effects on the welfare of the animals.

Question 3

What are the 3 R’s when considering using animals for a study?

Answer 3

Replacement = of animals with other methods
Reduction = in the number of animals used
Refinement = of techniques to reduce adverse impact on animals

Question 4

Outline the ethical considerations for researchers conducting human trials.

Answer 4

o Voluntary informed consent with no coercion
o Conducted for the good of society
o Based on animal experiments/biology of the disease
o Should not injure/cause harm/death to the participant
o Risk of experiment should not be greater than the benefit to society
o Conducted by scientifically qualified researchers
o Participant able to withdraw from trial at any time, without repercussions
o At any stage during the trial, the lead scientist should be able to terminate the trial to limit further risk to patients

Question 5

Explain the process involved in introducing a new chemical entity to market in Australia.

Answer 5

1. Human Research Ethics Committee (HREC) Approval
2. Site-specific Assessment (SSA)
3. Approval + yearly reviews
4. TGA approval

Question 6

Compare the process of applying for market authorization in registration in three jurisdictions.

Answer 6

TGA (Therapeutic Goods Administration)
o Australian register of Therapeutic Goods (ARTG)

EMA (European Medicines Agency)
o EU guidelines for registration adopted

FDA (Food & Drug Administration)
o FDA guidelines consulted where no EU

Question 7

Access and describe guidelines for drug development according the ICH.

Answer 7

ICH (International Council for Harmonisation; of technical requirements for registration of pharmaceuticals for human use)

• Established a standard format for registering drugs
• Common Technical Document (CTD)

Question 8

Outline the key features of the common technical document.

Answer 8

5 modules;

1. Regional administrative information
2. Clinical summary
3. Quality
4. Non-clinical study reports
5. Clinical study reports