Updated on 26 September 2012
Pharma firms seek inspiration from the Kangaroo to hop across regulatory hurdles in Australia
The life sciences sector in the Asia Pacific (APAC) region provides numerous opportunities for firms that are looking for growth in the region. Regulatory approvals are often a bottle-neck for these firms in the APAC region. BioSpectrum speaks to individuals from the industry and regulatory professionals from Australia, to compile a guide on the regulatory processes in the largest island of the world. (Also read during the week: Regulatory requirements in China, Taiwan, Hong Kong, India, Indonesia, Singapore and Korea)
In Australia, Therapeutic Goods Administration (TGA) is the government body responsible for carrying out a range of assessment and monitoring activities to ensure that the therapeutic goods available in the island country are of an acceptable standards. Moreover, the medicines are evaluated by the Drug Safety and Evaluation Branch (DSEB) of the TGA.
The Australian Drug Evaluation Committee (ADEC) is a statutory committee that provides independent advice to the Minister of Health and Ageing or the Secretary of the Department. ADEC's composition and terms of reference enable it to make medical and scientific recommendations relating to applications referred to it by the minister or the secretary. In Australia, the technical data requirements for the registration of medicines have been evaluated by the DSEB and are closely aligned with those required for applications for marketing authorisation of a medicine published by the European Union (EU). A list of EU guidelines adopted in Australia is also available from the TGA website.
The sponsor of a medicine in Australia is the person or company responsible for applying to the TGA in order to have their medicine included in the Australian Register of Therapeutic Goods (ARTG). The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia. The sponsor has to conduct pre-submission meeting with the TGA delegates to submit an application to the DSEB.
A face-to-face meeting with the TGA staff is appropriate for complex applications, especially if there is a need for either party to provide clarity on a particular issue or there is some uncertainty as to whether the registration dossier to be submitted will meet all Australian regulatory requirements.