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 […]
At the end of 2020, the post Brexit transition period will end. The UK will complete its exit from the European Union. Leaving the EU means that the regulatory landscape will change for the pharmaceutical industry. From, the 1st of January 2021 the Medicine and Healthcare products Regulatory Agency (MHRA) will become the UK’s only medicines […]
August 19, 2020,
TGO 91 & 92: Managing labelling reforms during COVID-19
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 […]
Currently there are more than 140 research teams working from around the world to develop a safe and effective vaccine against SARS-CoV-2, the virus causing COVID-19. From small start-ups out of university labs to large industry leaders, the race is on to provide a global solution to a problem that has had devastating health and […]
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, […]
COVID-19 has completely changed the world. For a while we could not visit the pub, we could not enter a gym and we were restricted to working from our homes. In Australia, we were seemingly succeeding in our fight against this novel virus but now with renewed lockdowns in Victoria, it looks like COVID-19 is […]
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