Pharmacovigilance inspection program: Guidance for medicine sponsors
Version 1.0, September 2017
Pharmacovigilance is defined by the World Health Organization as the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems. The Therapeutic Goods Administration (TGA) conducts a range of pharmacovigilance activities to monitor the safety and efficacy of medicines in Australia and, where necessary, take appropriate action.
The pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG) and regulated by the TGA are set out in the Pharmacovigilance responsibilities of medicine sponsors - Australian recommendations and requirements.
The TGA inspects Australian sponsors to assess whether they are meeting their pharmacovigilance responsibilities.
This guidance will help you understand our pharmacovigilance inspection program (PVIP). It outlines how we prepare, conduct, report and follow up pharmacovigilance inspections and lists the criteria we use when scheduling inspections.
In this guidance, we use 'must' or 'required' to describe something you are legally obliged to do. We use 'should' to recommend an action that will assist you to meet your legal requirements. We refer to the TGA as 'we' or 'us', and to sponsors as 'you'.
This guidance describes:
- how we prioritise and schedule pharmacovigilance inspections
- the kinds of inspections we might make and the inspection process
- the legal basis for pharmacovigilance inspections of all sponsors of medicines on the ARTG
All sponsors of medicines on the ARTG are subject to the Pharmacovigilance Inspection Program.
Sponsors of medicines approved for supply in Australia are legally responsible for meeting pharmacovigilance reporting requirements for their medicine (in accordance to subsection 28(5)(e) of the Therapeutic Goods Act 1989 and Regulation 15A of the Therapeutic Goods Regulations 1990).
We expect you to have an effective pharmacovigilance system in place to monitor and take appropriate action on the safety of your medicine, as outlined in the Pharmacovigilance responsibilities of medicine sponsors - Australian recommendations and requirements.
Your inspection-related responsibilities include, but are not limited to:
- ensuring your pharmacovigilance system adheres to Australian pharmacovigilance legislation and guidelines
- maintaining your readiness for inspection, as inspections may be unannounced
- ensuring any sites to be inspected, and any firms contracted by you to perform pharmacovigilance activities, agree to be inspected prior to inspection
- providing the inspectors, within the given deadline, with any information or documentation they need to prepare or conduct the inspection
- ensuring staff involved in pharmacovigilance or related activities are available (in person or remotely), where possible, during the inspection for interview or to clarify issues
- preparation and implementation of appropriate and timely corrective and preventative action (CAPA) plans to address the inspection's findings that prioritise any critical or major findings
- completion of a biennial report (once every two years) on your pharmacovigilance system via the electronic form provided, to assist in prioritisation of inspections.
Our inspection-related responsibilities include, but are not limited to:
- provision and review of the submitted biennial report on your pharmacovigilance system and prioritisation of inspections
- coordinating the inspection and personnel - including scheduling dates, times, venues - and providing the agenda
- conducting the inspection
- preparing the inspection report
- reviewing your CAPA plan(s) and finalising the inspection.
Objectives of the pharmacovigilance inspection program
The pharmacovigilance inspection program aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health by ensuring the continued safety of medicines.
Pharmacovigilance inspections allow us to:
- verify you are compliant with your pharmacovigilance responsibilities
- ensure you have robust pharmacovigilance systems in place to:
- collect and collate current information on the safety and efficacy of your medicines(s)
- assess the benefit-risk balance of your medicine(s)
- meet the mandatory reporting requirements
- take action to mitigate any identified safety issue(s)
- work with and educate you or, if necessary, compel your compliance to ensure you have effective pharmacovigilance systems in place in alignment with Australian pharmacovigilance guidance and legislation.
Scope of the pharmacovigilance inspection program
All Australian sponsors of listed and registered medicines on the ARTG are subject to the pharmacovigilance inspection program. The program will only include sponsors of medicines included on the ARTG.
Inspections will examine your compliance with the applicable Australian legislation and guidelines:
- Therapeutic Goods Act 1989, referred to as 'the Act' (section 28(5e), 29A and 29AA)
- Therapeutic Goods Regulations 1990 (Regulation 15A)
- Pharmacovigilance responsibilities of medicine sponsors - Australian recommendations and requirements (the Pharmacovigilance guidelines)
- Conditions - standard and specific (Applying to registered or listed therapeutic goods under Section 28 of the Therapeutic Goods Act 1989).
Inspections assess the appropriateness and compliance of your pharmacovigilance system in line with the Pharmacovigilance guidelines. At a minimum (for routine inspections), we will review the following aspects of your system during an inspection:
- the collection, collation, processing, timely and appropriate reporting and follow-up of adverse reaction reports
- where relevant, the preparation of Periodic Safety Update Reports (PSURs) and your adherence to risk management plans (RMPs)
- the ongoing analysis of the benefit-risk profile of your medicine(s) during the post-authorisation period, including analysis of global data where relevant
- the reporting of significant safety issues
- how you maintain any reference safety information to ensure product information is up-to-date and in line with current scientific knowledge
- whether your qualified person responsible for pharmacovigilance in Australia (QPPVA) is suitable and available, and what activities they undertake
- whether there are appropriate safety agreements in place and being adhered to with any company contracted to perform pharmacovigilance activities on your behalf
- clinical trials involving medicines on the ARTG where the medicine is used in line with the product information or label indications.