The TGA is continuing to consider minor changes to the proposed update of the Australian Pharmacovigilance Guidelines for Sponsors of Medicines 2011. There has been a long consultative process to bring the two product groups together and the proposed update will see the inclusion of ‘listed’ products rather than the dual guidelines currently in place.
A key requirement of the existing guidelines for Registered Medicines (and, therefore, one proposed for listed medicines) is the role of the Qualified Person (QP) for Pharmacovigilance.
The role of QP is not new to sponsors of registered medicines, but there has been a rapid recent increase in international companies registering products in Australia. Some of these companies are unfamiliar with the obligations of sponsors in regard to pharmacovigilance.
Finding a QP
The new TGA guidelines propose that ‘each sponsor of either registered or listed products must ensure that it has an appropriate system of pharmacovigilance in place in order to assure responsibility and liability for its products on the market and to ensure that appropriate action can be taken, when necessary’.
To ensure a robust pharmacovigilance system, the TGA stipulates that ‘[T]he sponsor should have permanently and continuously at its disposal, in Australia, a qualified person responsible for pharmacovigilance. This person should have experience in all aspects of pharmacovigilance and if not medically qualified, should report to or have access to a medically qualified person.’
To address this requirement, a sponsor should appoint such a person when approval is imminent. They must also then provide the TGA with this person’s details and, if different, the medically qualified person’s details. Many sponsors, however, do not have a person(s) with such experience in their local organisation. A contractual arrangement, as provided by Commercial Eyes, may then be the preferred option.
It is, however, important to recognise that the onus continues to reside with the sponsor to comply with their responsibilities. A clear agreement, which outlines each party’s responsibility, is therefore necessary in order to manage the relationship.
QPs and PV responsibility
The TGA Guidelines state that the QP is responsible for three main functions, the first of which is:
‘[T]he establishment and management of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the sponsor, including to medical and sales representatives, is collected and collated so that it may be accessed at a single point within Australia.’
The key elements for establishing and managing a PV system are:
- The establishment and maintenance of standard operating procedures (SOPs). The QP needs to be aware of, or support the development of, the written procedures relating to key pharmacovigilance activities. The system’s process needs to be fully documented, including organisational roles and responsibilities, processes for staff PV training (including sales representatives), collection and reporting of spontaneous adverse events, local literature surveillance and case reporting, signal detection, analysis and review, and business recovery plans, to name just a few. The QP should be part of the approval process to ensure compliance and also be aware of Company global pharmacovigilance procedures, where similarities and differences between Australian and international contexts might occur and be addressed.
- Data management. A database or data collection and collation mechanism is an essential feature of the requirement. It allows at a single point in Australia access to all information in regard to suspected adverse reactions. The QP must be aware of the system used to collect, evaluate and collate information concerning all suspected ADRs. There can sometimes be a perception that regulatory authorities require companies to establish expensive pharmacovigilance databases in order to satisfy these criteria. However, sponsors with small portfolios may demonstrate that simple spread sheets meet this requirement; the system does not have to be a computer database and the QP does not have to be at the location where collection occurs. They must, however, be able to obtain information at any time and be notified of any significant changes to a database or repository.
- QC and QA procedures. The QP needs to be aware of the systems of key QC activities, e.g. case processing and adequate documentation. The person should be involved in periodic QA audit of pharmacovigilance activities, and these should cover all departments that may receive AEs or that are involved in PV activities. Resulting audit reports and inspection findings should be made available to the sponsor and in particular the QP. Corrective actions of major findings made during an internal or external audit should be reported to the QP.
- Training. The QP should be trained and documented in all processes and systems relating to pharmacovigilance, and they should also be aware of how others are trained.
Further functions for QPs
The QP’s second function identified in the Guidelines is:
‘The coordination of the preparation and submission to TGA of ADR reports, including reports arising from company-sponsored Australian post-marketing studies’.
- Compliance data. The QP is not required personally to prepare reports, but they should have an overview of all ADR reports’ quality, completeness and timeliness.
The QP’s third function identified in the Guidelines is:
‘Ensuring that any request from the TGA for the provision of additional information necessary for the evaluation of the benefits and the risks afforded by a registered or listed medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the product concerned.’
Here, the QP must deal with:
- Requests from the TGA. To fulfil this responsibility the QP must have adequate access to safety information to ensure timely reports that meet TGA requests. This may include access to information at all offices and affiliates, and may also include preparation of PSUR’s or other safety reports as requested.
- Ongoing monitoring. For each of the sponsor’s products, the QP should have access to the overview of the safety profile and any emerging safety profiles. They should also have access to appropriate safety expertise.
As described above, the obligations of sponsors to provide robust systems and processes around post-market pharmacovigilance are extensive. The QP’s role is to ensure they are in place, monitor adhesion, and respond to signals and requests.
It should be noted that EudraLex Volume 9A places far greater legal requirements on the EU QPPV than the TGA QP. Because an EU QPPV has to be contactable around the clock, these requirements present a major financial and organisational challenge for small and medium-sized businesses.
The European Parliament and European Council in December 2010 adopted new pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). This represents the biggest change to the regulation of human medicines in the European Union (EU) since 1995. Whether the new legislation is adopted in part or full by the TGA, Australian sponsors will be interested to see if the TGA formally changes the QP’s role to increase the level of responsibility and legal liability.
For all your enquiries in regard to QP roles and responsibilities, contact Commercial Eyes’ Medical Services division.