The Therapeutic Goods Administration (TGA) has strong working relationships with a wide range of international agencies and is part of a network of international regulators that meet frequently to discuss the development of COVID-19 vaccines.
Through these relationships we are actively monitoring the COVID-19 vaccine development occurring both in Australia and around the world.
Australia is working internationally to share research and information supporting new COVID-19 vaccines. Indeed our ability to work collaboratively with like-minded countries will give greater assurances that new vaccines are safe, efficacious and manufactured appropriately.
WHO and ICMRA
The TGA supports the joint statement from the World Health Organisation (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) on the need for improved global regulatory alignment on COVID-19 medicines and vaccines.
To ensure patients have fast access to safe and effective medicines and vaccines, WHO and ICMRA committed to the following actions:
- working to prioritise well-designed clinical trials that will provide robust and reliable results
- ensuring that there are meaningful and scientifically sound endpoints and safety data of sufficient duration in clinical trials
- sharing data between regulators in real time to facilitate multi-country approvals
- putting in place processes and policies utilising the principles of regulatory agility by ICMRA members and WHO member states, providing an agile and rapid response to the global emergency
- committing to full transparency of clinical trial results to support regulatory decisions, as well as ensuring public trust in authorities and confidence in vaccines
- working together to prevent and/or mitigate shortages of critical medicines and vaccines
- continue working together once these COVID-19 therapies and vaccines are authorised and used to monitor their use, and identify, communicate and mitigate any safety or efficacy issues which may arise
- reduce the risks associated with unproven treatments, potentially fraudulent and false claims, which endanger patients' lives.
Through ICMRA, the TGA is currently meeting weekly with 30 international medicines regulators to enhance communication, information sharing, crisis response and address regulatory science issues in relation to potential COVID-19 vaccines.
The Access Consortium comprises medicines regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (UK), and its goal is to maximise international cooperation, reduce duplication, and increase each regulator's capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.
The recent addition of the UK brings the combined population of countries participating in the consortium to about 145 million. Pharmaceutical companies that submit applications to some or all Access countries will benefit from having their products evaluated for marketing in those countries simultaneously, with reduced evaluation times.
Promoting confidence in vaccines
ICMRA has issued a number of joint statements about the importance of the safety and effectiveness of vaccines. The ICMRA statements aim to reassure healthcare professionals and the public around the globe that medicines regulators only allow vaccines onto the market that fulfil the highest standards of safety, efficacy and quality.
- Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021)
- ICMRA statements on vaccine confidence and vaccine safety and effectiveness (available in 8 languages)
Further ICMRA activities include:
- ICMRA COVID-19 activities
- ICMRA statement on COVID-19: International regulators pledge collective support to combat COVID-19
- ICMRA statement on clinical trials: International regulators provide guidance on prioritisation of COVID-19 clinical trials