In order to cope with the current pandemic, governments around the world are being forced to rapidly adapt and change the regulatory landscape.
For medical device companies, the changing regulations can be an untapped opportunity.
Due to the global COVID-19 pandemic, governments and regulatory agencies around the world are scrambling to fast-track and prioritize healthcare products and pharma equipment that will help combat and control the spread of the disease. In Australia, the government, through the Therapeutic Goods Administration (TGA) has passed a law that is aimed to increase the number of available diagnostic tests for COVID-19. Beginning in March of this year, an emergency exemption was made specifically regarding in vitro diagnostic medical devices (IVD) for COVID-19.
The emergency pharma regulatory exception allows companies that have COVID-19 tests not yet registered on the Australian Register of Therapeutic Goods to immediately begin supplying products to accredited testing laboratories while the regulatory applications are being evaluated.
All new applications related to COVID-19 are also being expedited in order of priority. COVID-19 IVD tests are considered to be Class 3 IVDs by the TGA, and thus require full quality assurance procedures in accordance with Schedule 3 of the Therapeutic Goods Regulations published in 2002. However, due to the urgency of the situation, some premarket requirements such as the need to gather stability data are being exempt.
In addition to the new expedited process for the supply of COVID-19 tests, recently, the TGA has also released a notice that physical samples of biological medicines and biosimilars are no longer required for batch release until further notice. The purpose of this new notice is to ease the release of medicines during the current pandemic.