The Therapeutics Goods Administration Flashcards
What are the three divisions of the TGA structure?
- Medicines Regulation Division
- Medical Devices and Product Quality Division
- Regulatory practice and Support decision
Under the framework of the Therapeutics Act 1989 the TGA regulates the supply (import and export), manufacturing, and advertising of what?
- Medicines
- Complementary medicines
- Medical devices
- Products used to test various diseases or conditions
- Vaccines, blood products, and other biologicals
In relation to the evaluation, assessment and monitoring done by the TGA, therapeutic goods are 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
What does the national framework for the regulation of therapeutic goods in Australia ensure?
Quality, safety, efficacy and where appropriate, the timely availability of therapeutic goods
Who does the therapeutic good act 1989 apply to?
Applies to a ‘Sponsor’ who
- Imports therapeutics goods in to Australia
- Manufactures therapeutic goods in Australia
- Has therapeutic goods imported or manufactured on their behalf
- Exports therapeutic goods from Australia
For the regulation of medicines;
A) What do Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) evaluated for?
B) What are medicines that have a lower risk (medicines purchased over the counter, such as complementary medicines) assessed for?
C) How are medicines available for lawful supply by the TGA be identified?
A)
quality, safety and efficacy
B)
quality and safety
C)
- identified by either an AUST R (registered) number or an AUST L (listed) number on the outer packaging
How is the regulation of medical devices done?
Assessing compliance with a set of internationally agreed essential principles for their quality, safety and performance
What are some examples of ‘other therapeutic goods’ that the TGA applies a risk management approach to?
- In vitro diagnostic medical devices (IVDs)
- blood
- blood components
- plasma derivatives
- tissue and cellular products
- tissue and cell based derivatives
- sterilants and disinfectants
All medicines manufacture for supply in Australia must be _____ or ____ on the ARTG unless they are specifically exempted or excluded?
Listed or Registered
For listed medicines (AUST L);
A) What is their risk
B) Do they contain substances schedule in the susmp
C) What are some examples
D) Asssessed by the TGA for?
A)
- Considered to be of lower risk than registered medicines
B)
- Do NOT contain substances that are scheduled in the SUSMP
- May only contain well known established ingredients, usually with a long history of use
C)
- Most complementary medicines (e.g. herbal, vitamin and mineral products) and sunscreens are examples of listed products
D)
- Quality and safety
For registered medicines (AUST R);
A) What is their level of risk
B) What are they assessed for? What do sponsors have to obtain them?
C) What are examples of non-prescription (low risk) registered medicines?
D) What are examples of prescription (high risk) registered medicines?
A)
- Medicines assessed as having a higher level of risk must be registered
B)
- The degree of assessment and regulation they undergo is rigorous and detailed, with sponsors being required to provide comprehensive safety, quality and efficacy data
C)
- follow the route of evaluation described in Part 2 (over-the-counter) or Part 3 (complementary) of Registered Medicines of the Therapeutic Goods Regulations
- do not include ingredients described in Schedule 4, Schedule 8, or Schedule 9 of the SUSMP
- usually contain ingredients which are described in Schedule 2, Schedule 3, or sometimes Schedules 5 or 6 of the SUSMP
- e.g. Mild analgesics, cough/cold preparations, antifungal creams
D)
- follow the route of evaluation described in Part 1 (mainly prescription) of Registered Medicines of the Therapeutic Goods Regulations
- may include ingredients described in Schedule 4, Schedule 8 or Schedule 9 of the SUSMP
When do complementary medicines need to apply for status on the ARTG?
If they claim to alleviate, diagnose, cure or prevent a disease they are considered a therapeutic good
- Will be under listed goods (AUST-L) and are only tested for safety and quality not efficacy
When can medicines be excluded from the ARTG?
- Some products (mostly therapeutic devices, rather than medicines) may be unintentionally covered by the definition of a Therapeutic Good. They are therefore specifically excluded under section 7 of the Act.
- None of the requirements of the Act apply to excluded products
- An example of an excluded good is unmedicated soap
When can medicines be exempted from the ARTG?
Some medicines do not need to be registered or listed in the ARTG as a result of a specific exemption or determination. However, it is important to note that all other applicable requirements under the Act and Regulations (e.g. standards and advertising or labelling) must be complied with
- Exemption from ARTG listing
- Exemption from manufacturing requirements
- These goods are neither registered or listed
These goods are generally those goods where usage is considered to pose little risk to the general public
When may a drug that is exempt be revoked?
An exemption may be revoked by the regulations if the need becomes evident
- Some therapeutic devices, in particular, are excluded for the ARTG as they are often unintentionally covered by the definition of a therapeutic good
For the special access scheme (SAS) –>access to unapproved drugs accomplished;
A) What is it
B) What are there three categories?
C) How long does it take for the process
D) What is the process of the three different SAS to get the product?
A)
The SAS refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis
B)
Category A
- Medical practitioners can supply goods to very seriously ill patients without the approval of the TGA as long as the medical practitioner notifies the TGA within 28 days, using a Category A form
- The medical practitioner completes the Category A ‘Authority to Supply’ form and sends it to the supplier of the product and a copy to the TGA. This provides the supplier with the legal authority to supply the product
- The TGA does not send out a letter of approval or acknowledgment
Category B
- The unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C.
- Approval by the TGA is given on a patient by patient basis to reflect the needs of different patients
- Wherever possible, applications should be made in writing (preferably on a Category B form)
- Approvals for medicines accessed through this pathway are typically only issued to medical and dental practitioners
Category C
- Category C is a notification pathway (like category A), which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval
- Medical practitioner or someone acting on their behalf (e.g. pharmacist) is to complete a Category C form –> after the unapproved therapeutic good has been supplied through this pathway, and sent notificaiton to TGA within 28 days from date of supply
> Medicines (Governed by the Therapeutic Goods (Authorised Supply of Specified Medicines) Rules)
> Medical Devices (Governed by the Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules)
> Biologicals (Governed by the Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules)
C)
- Generally, for commonly requested products the TGA has a turnaround time of 2 working days from time of receipt of the application until a response is prepared and mailed
D)
- In the case of supply for a Category A patient, a completed notification form from the medical practitioner is required to be submitted to the sponsor before the sponsor can legally supply the product
- For Category B patients, an approval letter from TGA is required to be submitted to the sponsor before the sponsor can legally supply the product
- For Category C patients, the inclusion of the good in either one of the Category C categories acts as authorisation for this good to be supplied
