TGA: Seeks Feedback on Planned Adoption of 11 International Scientific Guidelines
Australia's regulatory authority, the TGA (Therapeutic Goods Administration), pursues a strategy of aligning its regulatory approaches as closely as possible with comparable international standards. These include the regulatory requirements of the EU, the FDA and the ICH. In this context, around 370 international scientific guidelines have already been adopted.
Eleven additional international scientific guidelines have now been considered for adoption, including nine documents from the European Medicines Agency (EMA). These include the latest reflection paper on the development of biosimilars. The TGA is also considering adopting two documents from the International Council for Harmonisation (ICH) on the selective collection of safety data in certain clinical trials and on technical specifications for clinical trial protocols.
Before adopting an international scientific guideline, the TGA conducts a comprehensive internal and external consultation process to ensure that the guideline in question is consistent with the requirements applicable in Australia. The current consultation period ends on 11 September.
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