Lecture 17 - Regulating Pharmaceuticals

Question 1

What are Regulatory affairs?

Answer 1

Area of work that involves responsibility for checking whether a business is following official rules or laws

Question 2

What do people in RA do?

Answer 2

• Work in regulated environments
  
  • Health Industry is regulated by Federal and States Laws, Regulations, Codes, Statements, Guidelines, Standards and quality management systems
  • Ensure a corporate entity complies with all of the above pertaining to their business (affairs)
  • Advise their corporate entity on the “Regulatory Climate”
  • Work with the Health Regulator in the jurisdiction where they
    ○ Want to do business (eg. Clinical trials)
    ○ Intend to market products (marketing authorisation - TGA)

Question 3

What are examples of Therapeutic Goods?

Answer 3

a. Pharmaceuticals
b. Biologicals as Medicines
c. Devices
d. Combination Products
Biologicals (2011)

Question 4

What are therapeutic goods?

Answer 4

§ Container/ closure system
- Broadly defined as products for use in humans in connection with
○ Preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
○ Influencing, inhibiting or modifying a physiological process
○ Testing the susceptibility of persons to a disease or ailment
○ Influencing, controlling or preventing conception
○ Testing for pregnancy
- Includes things that are
○ Used as an ingredient or component in the manufacture of therapeutic goods
○ Used to replace or modify of parts of the anatomy
- Device
○ Does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means

Question 5

What are the global regulatory considerations?

Answer 5

1. Quality (size of the tablet)
   
   2. Safety (Toxicology)
   3. Efficacy (Does it work)

Question 6

What is the drug development process?

Answer 6

1. Discovery and Development
   
   2. Preclinical Research
   3. Clinical Research
   4. FDA Review
      FDA Post-Market Safety Monitoring