Some situations are not covered directly by the reporting requirements detailed in section 2. The recommendations and requirements discussed below are not mandated as a part of this document, but may be mandated by other legislation, or recommended in guidelines.  

3.1 Record keeping requirements

Sponsors are required to retain records of all reports of ARs or similar experiences associated with the use or administration of their registered/listed drugs for a period of not less than 18 months from the day the TGA is notified of the report. This requirement is specified as a standard condition of listing or registration applied to all medicines at the time of entry onto the ARTG⁵⁸.

3.2 Reporting in the period between submission of a registration application and granting of the registration

In the period between the submission of a registration application, but before registration, sponsors are not required to routinely submit individual AR reports of which they become aware, except where the product is being used in Australia in a clinical trial. In these cases, sponsors should follow the reporting recommendations outlined in the separate guidelines for clinical trials⁵⁹.

In the pre-registration period, information that impacts on the benefit to risk evaluation may become available to the applicant from countries where the medicine is already in use on a compassionate basis, or from countries where the medicine is marketed. The applicant should submit this information in writing to the Office of Medicines Authorisation (OMA)⁶⁰, preferably in accordance with time frames for significant safety issues (section 2.4.2)⁶¹.

What constitutes a change to the benefit to risk balance is a matter of judgment for the applicant (although an applicant may be required to justify a decision not to report). For example, normally another report of a well-known AR would not be considered significant, but a report of an unexpected or new serious suspected reaction with good evidence of a causal relationship, or where there is suspicion of a change in the frequency or severity of a known effect, would be considered relevant to the evaluation. Similarly results from studies that impact on the assessment of efficacy would be considered significant.

When an application for registration for a prescription medicine is about to be considered by the Advisory Committee on Prescription Medicines (ACPM), sponsors should submit with their pre-ACPM response a tabulation of any serious unexpected ARs that are not mentioned in the proposed Australian PI and that have not already been submitted. This information should be submitted in writing to the OMA.

In the period after submission of the Pre-ACPM response, but prior to registration, sponsors are encouraged to report the following to the OMA in accordance with time frames for significant safety issues (section 2.4.2)⁶²:

• significant safety issues identified by the sponsor as a result of its ongoing review and analysis of all information. This information includes foreign reports of ARs, information about the safety or benefit to risk assessment of the product, or action taken by a foreign regulatory agency, and the basis for such action.

In instances where an application for registration of a medicine is withdrawn or lapses, section 29B of the Act provides that the Secretary of the Department of Health and Ageing may require a sponsor to disclose whether certain information about the product is known to the sponsor and, if that is the case, to provide that information to the Secretary.

3.3 Special Access Scheme (compassionate use/named patient) supplies

Reporting requirements for medicines supplied under the SAS are not mandated by this document, but are specified as either a condition of authorisation for the supply of the particular medicine, or through the requirement to prescribe the unapproved medicine in accordance with good medical practice.  

The use of the particular medicine for which authorisation has been granted in accordance with Section 19 of the Act is subject to conditions specified in the notice of approval, including AR reporting requirements (Section 19 of the Act provides that approval may be granted for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods, listed goods or exempt goods. This is also known as Category B of the SAS). The use of an unapproved medicine notified in accordance with Regulation 12A of the Regulations is subject to the condition that the medicine must be prescribed in accordance with good medical practice, which similarly encompasses AR reporting requirements (Regulation 12A of the Regulations provides that medicines are exempt from Part 3-2 of the Act, which includes the requirement to be included in the ARTG, subject to certain conditions. One of these conditions is that the patient meets the definition of a Category A patient. Such medicines are not exempt from section 31A and sections 31C to 31F of Part 3-2 of the Act).

The onus for reporting ARs from SAS usage lies primarily with the treating doctor. It is a condition of approval that the treating doctor reports the details of any actual or suspected ARs to the TGA. The sponsor of the medicine may also impose reporting requirements upon treating doctors if the sponsor chooses to do so. Sponsors should report to the TGA all those serious and unexpected ARs to medicines supplied under the SAS of which they have been informed. It is preferable that such reports are submitted to the OPR⁶³, who will forward them to the relevant area in the TGA.

Reporting timeframes and further information on reporting ARs under the SAS can be found in the guidance document Access to unapproved therapeutic goods - Special Access Scheme⁶⁴.

Footnotes

58. The TGA Internet site includes this condition in the document Conditions - standard and specific Applying to registered or listed therapeutic goods under Section 28 of the Therapeutic Goods Act 1989, which can be viewed online at DR4 - Appendix 4.
59. More information about clinical trials can be found on the TGA Internet site at Clinical trials.
60. Annex 1 lists relevant contact details.
61. Significant safety issues that become known to the sponsor prior to registration should be submitted to the OMA, whereas information that becomes known after registration must be provided to the OPR.
62. Significant safety issues that become known to the sponsor prior to registration should be submitted to the OMA, whereas significant safety issues that become known after registration must be provided to the OPR.
63. Annex 1 lists relevant contact details.
64. More information about access to unapproved therapeutic goods and the SAS can be found on the TGA Internet site at Access to unapproved therapeutic goods - Special Access Scheme.