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Biotechnology in Practice > L17 Regulating Pharmaceuticals > Flashcards

L17 Regulating Pharmaceuticals Flashcards

1
Q

Regulatory Science

A

the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products

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2
Q

Regulatory affairs

A

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

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3
Q

What we do - regulatory affairs

A
  1. work in regulated enviro.
  2. health industry is regulated by federal and state laws, regulations, codes, statements, guidelines, standards and quality management systems
  3. ensure a corporate entity complies with all the above pertaining to their business
  4. advise corporate entity on regulatory climate
  5. work with health regulator in jurisdiction where they want to do business, intend to market products
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4
Q

Two pathways

A

see onenote

  1. ethics and research governance
  2. regulatory agencies/competent authorities
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5
Q

Change in regulation

A
  • regulations can change based on real events or through proactive planning by regulators
  • change (usually) only happens after consultation with Industry EXCEPT in the case of safety/warnings
  • usually a transition period for implementation because change often effects R&D/commercial spend
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6
Q

Jurisdictional Requirements

A

see onenote

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7
Q

Marketing Authorisation

A

see onenote

Drug approvals up due to breakthrough designations/orphans

Sponsor - pharmaceutical company, biotech company, corporate company that funds the work
- The sponsor is responsible for everything unless they sell it off

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8
Q

Therapeutic Goods Administration (TGA)

A

see onenote

  • therapeutic goods for marketing must be on Australian Register of Therapeutic Goods (ARTG)
  • application process 225 calendar days
  • AUST R = registered, higher risk
  • AUST L = listed, lower risk
  • L or R depends on poisons scheduling of ingredients, therapeutic claims, type of product and degree of medical oversight
  • investigational products are exempt
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9
Q 
Therapeutic goods (TG) - what are they?
(corresponds to two slide)
A
  • pharmaceuticals
  • biological as medicines
  • devices
  • combination products e.g. asthma inhaler
Defined in the Therapeutic Goods Act 
Interpretation: 
- therapeutic use
- ingredient in manufacture of a therapeutic good
- container/closure system
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10
Q

Biologicals

A

TG made from, or that contains human cells or human tissues, or live cells, tissues or organs

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11
Q

Therapeutic use - TGA

A

see onenote

Defined broadly as products for use in humans in connection with…

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12
Q

What is a medical device?

A

see onenote

E.g. contact lenses, doesn’t cause biological responses, it is an “implant”

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13
Q

TGA Pyramid

A

see onenote diagram

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14
Q

Ingredients - Poisons Scheduling

A

see onenote slides

Poisons scheduling = What category any compound sits in terms of risk

  • The higher the number, the higher the risk
  • product specific and risk
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15
Q

Global Regulatory Considerations - 3 poitns

A
  1. quality - manufacturing
  2. safety - toxicology
  3. efficacy - does it work?
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16
Q

Drug Development Process

A

see onenote

  1. discovery and development
  2. preclinical research
  3. clinical research
  4. FDA review
  5. FDA, post-market, safety monitoring
17
Q

Drug Development Considerations

A

see onenote

  1. is it safe?
  2. is it better?
  3. how does it compare to standard of care?
  4. does it work?
  5. breakthrough?
  6. can you sell it?
  7. should it be on the Pharmaceutical Benefit Scheme (PBS) or Medical Services Advisory Committee (MSAC)?
18
Q

GXPs - Guidelines setting out Principles

A

see onenote slides

GMP - good manufacturing practice, Quality

GLP - good laboratory practice, governs lab practice and procedures, Safety

GCP - good clinical practice, clinical trial conduct, efficacy

19
Q

CMC

A

see onenote

Chemistry, Manufacturing, Controls

There are regulations for each excipients as well - not just regulations for active ingredients

20
Q

Preclinical research

A
  • still required although minimising animal use

standard toxicology batteries include

  1. repeat dose (rodent/non-rodent e.g. non-human primate)
  2. safety pharmacology
  3. in vitro/in vivo mutagenesis
  4. chronic carcinogenicity
  5. others, product specific

animal data not overridden by human data HOWEVER, may be omitted if justified

21
Q

Physiologically-based Pharmacokinetic (PBPK) modelling

A

see onenote diagram

22
Q

Does the regulation stop? No

A
  1. post-marketing commitments
  2. ongoing quality control for every batch
  3. sponsor provides Periodic Safety updates
  4. therapeutic claims (advertising code)
  5. therapeutic use - new product
  6. regulatory surveillance
  7. pharmacovigilance
23
Q

Action by the TGA

A

decrease in the amount of codeine supplied to Australians

24
Q

Regulatory Surveillance - Story

A

see onenote

25
Q

TGA vs FDA

A

see onenote table

26
Q

Summary

A
  1. regulatory requirements are harmonised
  2. different jurisdiction have different laws
  3. three regulatory principles of: Quality, Safety and Efficacy
  4. GLP, GMP, GCP
  5. animal and human drug data important
  6. risk-based approach to regulation
  7. regulation driven by public events and risk
  8. surveillance leads to change

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