Chemistry, Manufacturing and Controls content
Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR
European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.
Diverse and dynamic regulation in the Asia Pacific region
Starting in Australia, authors David Batka and Kate Burke look at the trends within its market for 2024. Two years ago, the Australian government and its regulatory agency, the Therapeutic Goods Administration (TGA), initiated an expert review of medicine and device regulations to bring about reforms for patient access, flexible ...
Navigating the regulatory terrain down under: trends in Australia for 2024
Australia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the country’s above-average wealth. Factors such as a skilled workforce, high-quality research infrastructure, government incentives and well developed regulatory and health technology ...
