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International scientific guidelines adopted in Australia

5 August 2020

The TGA closely aligns its regulatory approaches to therapeutic products with those of comparable international regulatory counterparts wherever possible.

Technical data requirements for applications to register or vary the registration of medicines in Australia are closely aligned with requirements set out in relevant:

  • European Union (EU) Guidelines
  • Guidelines issued by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • Food and Drug Administration (USA)

International Guidelines are not limited to prescription medicines, but may also apply to OTC, complementary and some listed medicines. It is important that you review the relevant guidelines that are adopted in Australia prior to manufacturing and supplying a medicine.

While guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements and any deviation from a Guideline relevant to an application to register or vary the registration of a medicine must be justified.

Prior to adopting any Guideline, the TGA undertakes an extensive process of internal and external consultations to ensure the Guideline is consistent with prevailing requirements in Australia. TGA publishes a searchable list of International Guidelines adopted in Australia. Please check for current consultations on proposed guidelines for adoption in Australia.

Please note: Where EU Guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.

International scientific guidelines adopted in Australia

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Overseas effective date: 12 Dec 2017

Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems (Rev 2)

Replaces: EMA/838713/2011 Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems. (Adopted by TGA 10 April 2014)

Categories: Pharmacovigilance

Proposed TGA annotations:

Risk management plans updates: an updated EU RMP (accompanied by an Australian-specific annex) should be submitted at the request of the TGA and whenever the EU RMP is modified as a result of new information which may change the risk-benefit balance of the product or as a result of an important pharmacovigilance or risk minimisation milestone being reached. Refer to the TGA guidance 'Risk management plans for medicines and biologicals - Australian requirements and recommendations' for more information.