Lecture 4_Biotech regulatory bodies Flashcards
(15 cards)
What are the two main types of legislative instruments in therapeutic goods regulation?
Acts – Primary legislation passed by Parliament.
Regulations – Secondary legislation created under the authority of an Act
Act vs Regulation
Passed by -
Act: Parliament
Regulation: Authorised bodies
Purpose -
Act: Establish general laws (framework)
Regulation: Detailed rules to enforce act
Process:
Act: Needs debate, and approval by both sides
Regulation: more quickly, no full debate needed
What are the key biotech regulatory bodies in Australia?
TGA (Therapeutic Goods Administration)
OGTR (Office of the Gene Technology Regulator)
FSANZ (Food Standards Australia New Zealand)
What are some international biotech regulatory bodies?
FDA – United States
EMA – European Union
MHRA – United Kingdom
List three key differences between the TGA and FDA.
Size – FDA (~15,000 FTE); TGA (~750 FTE)
Interaction – FDA gives early feedback and posts warning letters; TGA usually does not
Disclosure – FDA requires financial disclosure in trials; TGA does not
How are therapeutic goods defined in Australia?
Products used in humans to:
- Prevent, diagnose, or treat disease
- Influence physiological functions
- Control conception or test pregnancy
- Test for disease susceptibility
(Also includes ingredients, components, or containers)
List the 4 main types of therapeutic products regulated by the TGA.
Pharmaceuticals
Biologicals
Medical devices
Combination products
What are biologicals?
Therapeutic goods derived from or containing human or animal cells, tissues, or organs
How are medical devices classified by risk?
Class I - Lowest (ie Tongue depressor)
Class Is (sterile) + Im (measuring) - Low
Class IIa - Low to Moderate (ultrasound mach, Detal Drill)
Class IIb - Moderate to high (Surgical laser, X-Ray)
Class III - High (Absorbably sutures, Pacemaker)
What is the ARTG?
The Australian Register of Therapeutic Goods—a list of approved therapeutic goods that may be supplied in Australia
What do AUST numbers on medicines indicate?
AUST R – High-risk products, assessed for safety and efficacy
AUST L – Lower risk, not usually evaluated for efficacy
AUST L(A) – Low risk, but efficacy is evaluated
What happens after a product is added to the ARTG?
Periodic safety reporting
Therapeutic claims review
Advertising code compliance
Pharmacovigilance
Regulator surveillance & audits
What is the ICH?
The International Council for Harmonisation, which creates global standards but is not a regulatory body itself
What is the Common Technical Document (CTD)?
A harmonised format for regulatory submissions used globally, organised around three pillars: Safety, Quality, and Efficacy
What is marketing authorisation in biotechnology?
Marketing authorisation is the formal approval granted by a regulatory authority (e.g. TGA) allowing a therapeutic good to be lawfully sold and marketed
