Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance studies

General remarks

These guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity. Most of these have been observational studies employing a cohort design. However, the guidelines apply equally to other types of study including case control studies, intensified monitoring and various forms of recorded release.

The term "post-marketing surveillance (PMS) study" implies a scientifically rigorous study of a product that is approved for registration in Australia designed to produce reliable information about drug safety. It is not appropriate to apply the term to clinical trials of registered products or to studies designed primarily for marketing purposes regardless of the scientific validity of the study design.

PMS studies are generally performed on the initiative of the sponsoring company, but may be suggested or requested by other parties. They should generally be designed to address a specific drug safety question or hypothesis (the latter often identified initially by voluntary reporting).

These guidelines have been formulated:

• to encourage the design and conduct of scientifically sound and ethical studies;
• in an attempt, therefore, to maximise the possibility that the results of PMS studies may have scientific validity and offer new and useful information on the drugs being studied;
• to minimise the generation of large volumes of poor-quality adverse event or "experience" reports which may be resource- and time-intensive to analyse and may diminish the voluntary reporting scheme's ability to generate true drug safety signals by diluting the database.

The specific guidelines

1. The motivating force behind a PMS study should be the need to answer a specific medical question, which is significant, new and otherwise not likely to be answered by existing voluntary reporting schemes.
2. In company-sponsored PMS studies which are to be observational rather than experimental, the decision to enter a patient in such a study should be made after and independently of the clinical decision to prescribe the study drug in that particular patient.
3. The notification of adverse reactions occurring during the PMS study should be carried out according to the relevant section of the appropriate TGA pharmacovigilance guideline (found in Australian pharmacovigilance requirements and recommendations for medicine sponsors).
4. The sponsor company will be responsible for undertaking and reporting on the outcome of the study in accordance with internal protocols and any conditions of registration. Reports may also be requested by the TGA when required5..The product to be studied must be approved for registration in Australia, and only patients being treated for approved indications of the product should be included in PMS studies.
5. Company-sponsored PMS studies should not be disguised marketing or promotional exercises.
6. Any payment offered to the medical professional must be commensurate with the work involved.

These guidelines describe the scientific approach to be followed by pharmaceutical companies in regard to the design and conduct of company-sponsored post-marketing surveillance (PMS) studies. Although these are guidelines and are therefore not obligatory, pharmaceutical companies are encouraged to comply in a spirit of cooperation.

Any comments or enquiries in relation to these guidelines should be addressed to: