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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

Strict monitoring requirements are in place to ensure the ongoing safety and efficacy of medicinal products supplied on the market.

Obligations include:

  • ensuring that therapeutic goods – including medical devices – are registered in or listed on the Australian Register of Therapeutic Goods;
  • reporting any adverse events to the Therapeutic Goods Authority (TGA);
  • keeping records pertaining to the reporting requirements and safety for the medicine at issue pursuant to Section 28(5)(ca) of the Therapeutic Goods Act (Therapeutic Goods Act); and
  • responding to any requests made by the TGA for additional information fully and within the specified timeframe pursuant to Section 31(1) of the Therapeutic Goods Act.

The TGA has published guidance on the pharmacovigilance responsibilities of medicine sponsors on its website.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

The TGA collects therapeutic goods information and may release this information to, among others, the following:

  • the World Health Organisation, authority of the Commonwealth (Section 61(2) of the Therapeutic Goods Act);
  • a state or a territory that has functions relating to therapeutic goods (Section 61(3) of the Therapeutic Goods Act); and
  • a third-country national regulatory authority that has national responsibility for therapeutic goods (Section 61(4) of the Therapeutic Goods Act).

Sponsors should be aware of the regulations surrounding the privacy of information. For example, an organisation generally needs an individual's consent before it can collect that individual’s health information. Health information about an individual is classified as ‘sensitive information’ (Section 6 of the Privacy Act 1988). All private sector providers are covered by the Australian Privacy Principles.  

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