AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
their devices to the TGA, including events that led or might have led to death, serious injury or serious deterioration in health. Sponsors must also maintain a post-market surveillance system including systematic review of post-market experience. Common Obligations (Medicines and Medical Devices) Sponsors must ensure continued compliance with Good Manufacturing Practice and conformity assess- ment requirements throughout the product life cycle, pay annual ARTG charges, and ensure that product information, labelling and advertisements are kept up to date and in line with TGA requirements. For both medicines and medical devices, a sponsor must fol- low the TGA’s procedure for recalls, product alerts and product corrections (PRAC) and – except where immediate action is required – must engage with the TGA and receive its approval before taking in-field action in relation to a recall. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations The TGA publishes on its website a database of appli- cations for new medicines or new uses for existing medicines that are currently under evaluation by the TGA. The following will be published on this database: • information about applications for a “new medi- cine” containing a new active substance (new chemical entity or new biological entity) not cur- rently approved in Australia; • applications for a “new combination” where two or more already approved medicines are combined into a single product; and • applications for a “new indication” or additional therapeutic use for an already approved medicine. Using this “Prescription Medicine Applications Under Evaluation” database, third parties can review the pro- posed product trade name, active ingredient(s), the applicant (who will become the sponsor), a summary of the proposed indication and the application type. The database is updated monthly. Once the TGA has made its decision in relation to an application, the following applies.
• If approved and included in the ARTG, a third party can access the product name, sponsor, active ingredients, ARTG number, and conditions of regis- tration (if any, in addition to the standard conditions imposed by statute) via the publicly accessible ARTG. • For approved prescription medicines, an Australian Public Assessment Report (AusPAR) that summa- rises the clinical, non-clinical and quality evalua- tion, including the basis for the decision, may be published on the TGA’s website. The TGA’s guid- ance is that AusPARs will typically be published for products containing new chemical and biological entities, biosimilar medicines, major variations and extensions of indications where the TGA deci- sion-maker received independent expert advice, or where the information is considered to be in the interest of the Australian public. An AusPAR may still be published even if an application was rejected. • The TGA also publishes prescription medicine decision summaries (AusPMDSs), providing a brief overview the TGA’s assessment and decision to approve or not approve a new prescription medi- cine. Information about applications for medical devices is not published. Section 61 of the Therapeutic Goods Act prohibits TGA officials from disclosing “protected information”, which broadly includes any information obtained under the Act that is not publicly available, except in specified circumstances (eg, to protect public health, for law enforcement, or with the sponsor’s consent). Furthermore, Australian privacy legislation would ordi- narily prohibit the publication of information relating to individuals (especially health or other sensitive infor- mation), unless they have expressly given consent. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes The TGA offers several accelerated pathways for therapeutic goods.
17 CHAMBERS.COM
Powered by FlippingBook