Questions and Answers about the proposed arrangements for Product Vigilance in the ANZTPA
February 2007
Product vigilance is a range of activities designed to monitor, assess, evaluate and improve the safety of therapeutic products. This includes, but is not limited to:
- Reporting adverse reactions to therapeutic products;
- Adverse event and problem reporting and investigation;
- Product safety updates and reviews;
- Expert committee assessments;
- Reviews of product safety literature;
- Post-marketing research;
- Communicating possible risks to stakeholders.
What is the proposed system for product vigilance under the Australia New Zealand Therapeutic Products Authority?
Product vigilance requirements will apply to all therapeutic products and the requirements will vary depending on the risk characteristics of the product.
Proposed requirements include proactively monitoring product safety during its life cycle. For high risk products this may require the product sponsor to perform a range of product vigilance activities including:
- Spontaneous reporting;
- Additional targeted research;
- Linked database and data analysis;
- Post-marketing safety studies.
Will product vigilance data be made publicly available?
The ANZTPA aims to have greater transparency around adverse event reporting and would like to work with industry around this area. It is envisaged that data from the ANZTPA database of adverse reactions reports would be made available electronically and outline, for example, the numbers of adverse reactions to medical devices and medicines. In the United States, the Food and Drug Administration makes available information about adverse reactions to medical devices and pharmaceutical medicines and this has not impacted negatively on industry.
What does the term international birthday mean for a product?
The term international birthday is the date a therapeutic product first gains regulatory approval in an established OECD market.
What is the timeframe requirement for providing Product Safety Update Reports?
Product sponsors are required to actively monitor any problems with their therapeutic products and report them. This should be undertaken from the date of a product’s international birthday for up to three years or longer and include data on:
- Adverse events in Australia and New Zealand;
- Overseas adverse events;
- Papers and research;
- Any international action.
This monitoring would also need to be undertaken for replacement or generic products to ensure any problems with variations in a product are picked up.
Will the Authority commission studies as part of product post market surveillance?
The ANZTPA will be able to commission studies or research that looks into post market surveillance. In addition, post-market studies may be recommended as a condition of registration as currently occurs in similar jurisdictions around the world. The budget for the ANZTPA-commissioned research will be discussed as part of the annual review of fees and charges.
What is the role of the designated person, responsible for pharmacovigilance within a sponsor company?
For high risk medicines and blood products, product licence holders would need to appoint a "Designated Person" who would be responsible for the oversight of the complete vigilance system for that product. This would include quality control and assurance procedures, standard operating procedures, database operations, compliance data, audit reports and training of personnel in relation to product vigilance. In addition, the person is responsible for the investigation of complaints, and adverse events, and the submission of reports to the agency in relation to reportable events and other information. The Designated Person for each product licence holder should be a resident in Australia or New Zealand and should have access to appropriate knowledge regarding the practice of medicine in the Australian and New Zealand health systems.
What is the role of risk management plans in the product vigilance system?
All applications for a product licence for a high risk medicine or blood must include the submission of a product-specific risk management plan. Approval of the plan would be required before the product licence could be granted. The plan would set out a system of vigilance activities and interventions designed to identify, characterise, prevent and minimise risks related to the product.
For medical devices, the risk management plan is a combination of the risk analysis and mitigation activities undertaken at the time of product design, and the corrective and preventative action (CAPA) plans and procedures incorporated in the manufacturer's quality management system to assist in ensuring compliance with the reporting requirements of the regulatory framework.
What is meant by a provisional licence?
In exceptional circumstances, where the ANZTPA has assessed an application for a product licence and considers that a product licence should not be issued, the Managing Director may, in consultation with the applicant, consider granting a provisional licence. A provisional product licence would be for a time-limited period and subject to conditions and further evaluation of the product prior to completion of the provisional authorisation period. Further information on provisional licences is included in p22 of the Plain English Guide to the Draft Medicines Rule, Draft Medical Devices Rule, and key components of the Draft Administration and Interpretation Rules - May 2006 (pdf,417kb)[http://www.anztpa.org/about/regscheme.pdf].
URL: http://www.anztpa.org/safety/qavigilance.htm