Development of Vaccines for Australia: TGA Regulations and Approval process

Since Edward Jenner’s creation of vaccine 200 years ago, which been serving as a boon to mankind till today and being benefited by vaccination. Childhood vaccination is done for infectious disease like Polio, measles, rubella etc. Apart from these childhood vaccinations, vaccine for communicable diseases also been developed which is leading to improvement of quality and standard of life. In 20th century there are many modern methods and improvised methods for vaccine development and immunisation. With all improvised technique they need monitoring during their manufacture. Introduction of any new vaccine to the market requires registration, approval, licensing etc. Individual country regulations should be followed, guidelines to be adhered to and submit all required documents. Upon approval they can market their product with all legal rights. In Australia, Therapeutics Goods Administration (TGA) regulates the approval vaccines and medicines and some lifesaving drugs. TGA has introduced two new pathways for rapid approval for life saving drugs for emergency use. The main objective of rapid approval process is to make sooner available of drug sooner than the usual regulatory process.