PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report.

Although TGA staff were diverted from their established business priorities this year, the agency was able to meet all its timelines for drug and device reviews.

Eleven new medicines and extension applications were evaluated as priority applications. The time for approval for each of the pathways was within legislated timelines.

For COVID-19 drugs and devices, the TGA granted 49 approvals through April and May 2020 to supply overseas registered product to address medicine shortages, and it received a 51% increase in advertising complaints over the year, with COVID-19 a significant contributor to this.

A major focus for the year ahead will be a digital transformation for the TGA to update its internal systems and to implement a new unique device identification (UDI) program to track and trace implanted medical devices. The details are still being worked through via public consultations.

The agency expedited the assessment of medical devices, hand sanitizers and disinfectant applications associated with the detection, prevention and treatment of COVID-19, ensuring Australia had needed products to support the pandemic response. At the same time, the agency met all statutory timeframes for reviewing other non-COVID products.

The TGA approved 38 new chemical entities in roughly 196 working days for the standard pathway, compared to the legislated timeframe of 255 working days. It approved 53 indication extensions in a median 185 working days, and it approved 11 medicines and indications via the priority evaluation pathway in a median 122 working days compared to an operational target of 150 working days.

The TGA published 144 new guidance documents during the year and updated 62 guidances. Key guidances published included:

  • Medical device cyber security guidance for industry;
  • Advertising guidance for businesses involved with medicinal cannabis products;
  • Advertising guidance for businesses involved with stem cells and other human cell or tissue products;
  • Export of human substances;
  • IVD companion diagnostics;
  • TGA instructions for disinfectant testing; and
  • Ventilators for COVID-19 use in Australia.

The agency is continuing preparations for the regulation of software, including Software as a Medical Device (SaMD), which was slated to become effective in August 2020, but the agency delayed the implementation date to February 2021. During that time it held numerous workshops to inform industry of the new reforms.

Compliance activities

A new framework for advertising complaints was introduced in 2018 with a risk-based approach to categorizing complaints. Each case was categorized based on the risk to public health with corresponding actions escalating as appropriate.

To that end, the agency sent 684 regulatory obligations letters to advertisers identified in low-risk cases, and it sent a number of warnings and cease-and-desist letters were for medium risk cases. It sent 187 infringement notices and initiated two court proceedings against two companies and their directors for unlawful advertisements of therapeutic goods that pose serious risks to public health and safety. Five matters were referred to the Commonwealth Department of Public Prosecution.

In addition, 3,299 compliance investigations in relation to the supply, manufacture, import or export of therapeutic goods were finalized, and 753,897 units of non-compliant goods were destroyed during the period, the TGA said.

The TGA streamlined enforcement actions and issued several infringement notices for alleged breaches of the Therapeutic Goods Act 1989, including for the use of inappropriate COVID-19 claims in advertising and the supply or promotion of unapproved goods in relation to COVID-19. The TGA has also initiated civil proceedings in relation to several COVID-19-related matters involving high-risk goods.

Out of the 690 recalls issued for drugs and devices, 95 were class I recalls that could have resulted in serious injury or death to patients or users; 507 were class II recalls with the potential to cause illness, injury or result in mistreatment; and 88 were class III recalls that may not pose a significant hazard but required action.

International engagement grows

The TGA continues to collaborate with international bodies and to use comparable overseas regulator (COR) pathways to minimize the regulatory burden on industry. Ongoing collaboration with international regulators has streamlined compliance and monitoring activities in areas such as breast implants, manufacturing inspections, and drug shortages.

More than 90% of entries on Australia’s Register of Therapeutic Goods (ARTG) use supporting evidence documents from comparable overseas regulators. This reduced duplication of assessments, and documentation included assessments and approvals from European notified bodies and regulators in the U.S. Canada or Japan.

During the year, the TGA collaborated with Health Canada, the Health Sciences Authority of Singapore and Swissmedic in evaluating six new medicines. It conducted six joint or concurrent GMP inspections with international counterparts, and it acted as an observer on nine occasions with international counterparts.

For medical devices, the TGA participates in the Medical Device Single Audit Program (MDSAP) as a joint venture with regulators in the U.S., Canada, Brazil and Japan. MDSAP allows for recognized auditing organizations to conduct a single program of regulatory audits of a medical device manufacturer.

With COVID-19 travel constraints, all international inspections were postponed for the remainder of the financial year, with remote inspections of international manufacturers recommencing in July 2020, and remote assessment of MDSAP auditing organizations commencing in May 2020.

The TGA leverages GMP inspections performed by overseas regulators to avoid the need to conduct on-site inspection for the same manufacturer. Almost 3,800 applications were approved via these mutual recognition agreement pathways.

The domestic GMP inspections program continued to be delivered either via a remote domestic inspection or a hybrid inspection with remote and onsite components.

During the year, the agency conducted 214 inspections (163 domestic and 51 overseas) of regulated entities. It conducted 36 on-site audits (21 domestic and 15 international) of medical device manufacturers.