Lecture 6: How A Medicine Reaches The NZ Market Flashcards
What is the significance of a pregnancy test as a form of medicine?
By NZ law the pregnancy test is a medicine, in other countries it is a medical device
What is the definition of a medicine by the Medicines Act, 1981 S3:?
“Any substance or article other than a medical device that is manufactured, imported, sold or supplied wholly or principally; for administration to human beings for a therapeutic purpose and where it is so used:
- in a hospital or pharmacy OR
- by a practitioner, midwife, designated prescriber or
- in accordance with a standing order, or
- In the course of any business that consists of or,
- for use as pregnancy test
What is a therapeutic purpose?
A therapeutic purpose means the substance is used for
- treating or preventing a disease
- altering the shape, structures size or weight of the human body
- preventing or interfering with the normal operation of a physiological function
Who developed the ideal scientific basis for selective toxicity and screening?
Paul Ehrlich (1854-1915)
How were medicines discovered before the end of the 19th century?
By chance and serendipity
How are drugs discovered?
- from plants and traditional remedies
- from endogenous agents in animal
- by serendipity
- application of metabolites of existing drugs
- empirical chemistry & pharmacology
- rational molecular design and modelling
- combinatorial chemistry and HT screening
What is serendipity?
Good fortune or luck
What is HT screening?
High throughput screening
- method for scientific experimentation especially used in the drug industry
Which industry is responsible for the research and development of over 90% of new drugs produced..
The research based pharmaceutical industry
What scientific techniques are making drug discovery an even rode scientific process than previously?
Applied molecular biological techniques
Molecular modelling
Prospect of genetic technologies
What does it take to develop a new medicine on average?
Up to 12 years,
Thousands of pages of data
1.1billion NZD
What is the likelihood that a drug will make it to the market ?
Only one compound in 10,000 initial molecules actually make it to the market
Why do we regulate medicines?
So we have an assurance of
Quality (stability, purity) Safety Efficacy We need to update information Pharmacovigilance - the kinds of things we need to look at
What are the key activities of the regulation of medicines?
Control of the manufacturing chain Control of the distribution chain Pre-market evaluation and approval Post- market surveillance Control of access to medicines
Who regulates our medicines?
FDA- in USA
TGA- in Australia
Medsafe- in NZ: New Zealand Medicines and Medical Devices Safety Authority