In a world of globalisation, in-licensing and acquisitions of pharmaceutical products is a common occurrence. In fact, to facilitate global development and harmonisation, TGA has adopted numerous scientific guidelines[a] and recognises evaluations of many jurisdictions with standards similar to its own, such as EMA, FDA, MHRA, PMDA, Health Canada and SwissMedic[b]. When it comes to […]

The TGA and pharmaceutical industry have been long preparing for the upcoming TGO 91/92 labelling reform deadline slated for 31 August 2020. However, as it has for many other sectors, COVID-19 has created difficulties for pharmaceutical companies to meet this labelling reform deadline. Therefore necessitating some interim measures. The labelling reforms As a refresher, 31 […]

Outsourcing is increasingly common within the pharmaceutical and medical device industries, especially within the Regulatory Affairs, Pharmacovigilance and Medical Information functions. Regulatory Affairs outsourcing in particular is very common, with many companies seeking expert support and partnership for new products and the effective management of operational tasks. In an evolving marketing environment driven by; mergers, […]