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
What is the Medsafe mission?
To enhance the health of NZers by regulating medicines and medical devices to maximise safety and benefit (and minimise harm)
What are functions of Medsafe?
- Evaluate applications from manufacturers wishing to market a new medicine
- Approve clinical trials on new medicines
- Monitor the safety of medicines and medical devices
- Issue licenses to importers and distributors of medicines
What do regulations define
Rules on manufacturing and purity of medicines
Animal data require before human study approval
Safety and efficacy levels required for approval of marketing
The types of claims allowed in medicines advertising
What are the regulations in labelling?
Writing a drug label is part of the approval process.
Label must contain data on the:
- pharmacological actions
- approved use
- side effects
- dosing of drug for prescribers
This content of the label is defined by LAW
What is a clinical trial?
Any research on human subjects conducted to gain new knowledge into mental and physical health and disease
They involve a wide range of health professionals and are usually conducted in hospitals, the community, or academic institutions
They are usually divided into 5 distinct phases
What are the 5 phases of a clinical trial?
Phase I: evaluation in volunteers- date of drug in body and safety profile
Phase II: initial studies in patients- proof of concept and dose ranging
Phase III: pivotal proof of effectiveness and safety. Multicentre controlled
Phase IV: comparative trials
Phase V: new indications
How is approval of a clinical trial achieved?
- Through the ministry of health
- Applications for approval are assessed by the Health Research Council a standing Committee of the Therapeutic Trials
- requires submission of all preclinical, clinical data and clinical trial protocol
What are the regulations for New Drug Approval in NZ
- Requirement for the Approval to market a medicine in NZ are set out in the Medicines Act 1981 and Regulations 84
- Approval granted by the Minister of a health on advice from the ministry through Medsafe a business unit of the Ministry of health
List the post- marketing activities
Medicines testing programme Compliance monitoring Complaints investigation Pharmacovigilance (adverse reactions monitoring) Publications Regulatory action
What are compliance activities?
Good manufacturing practice (GMP) audits RCA,Los and complaints Medicines testing Medicines device monitoring Licensing activities : -wholesales license -pharmacy license -importing license
What are the different levels of access to medicines?
Medicines are classified by the medicines classification committee:
Prescription medicines - require legal document
Restricted medicines- via pharmacist only
Pharmacy only medicines - can only be sold in pharmacies where a pharmacist has supervision
General sales medicines - anyone can buy
What are the issues considered if a medicine has to be reclassified?
Toxicity, abuse potential, inappropriate use, precautions, communal harm, convenience, potency, current availability, therapeutic index
What agency handles the subs ideation of patient access to medicines by the government?
Pharmacy Management Agency Ltd (PHARMAC) est in 1993
What is the mission of PHARMAC ?
To balance between the needs of the patients for equitable access to health care with the needs of the tax players for responsible management of costs
Why are medicines regulated?
For their quality, safety, efficacy,
Distribution chain,
Categorisation,
Modification
How is getting a drug subsidised different to registration of a drug?
It undergoes a different process, monitored by different a agency
