Our Articles

Explore our thought leadership article library, where you can find a wealth of insights on regulatory intelligence, industry updates, and the latest pharmaceutical and biotechnology developments.

Becky Murphy Becky Murphy

Therapeutic Vaccines – Regulatory Challenges for Non-Clinical Development

Therapeutic vaccines differ from traditional prophylactic vaccines in that they are not targeted to a foreign antigen/protein but instead are intended to modulate the host immune system to endogenously present antigens and are routinely administered after an infection, cancer or other chronic disease state is established.

Read More
Becky Murphy Becky Murphy

FDA 483 - Navigating Compliance Challenges

An FDA 483, also known as a “Form FDA 483” is a document issued by the U.S. Food and Drug Administration (FDA) to a company at the conclusion of an inspection, when the FDA investigator has observed any conditions that in their judgement may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts. 

Read More
Becky Murphy Becky Murphy

Expedited Approvals of Medicinal Products

Developing a novel drug, including discovery, nonclinical toxicology studies, and clinical studies, may take many years. Once a Company has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the marketing authorisation application. 

Read More
Becky Murphy Becky Murphy

Transition of Ongoing Clinical Trials in the EU 

In the evolving landscape of clinical research and regulatory frameworks, Regulation 536/2014, also referred to here as the Clinical Trials Regulation (CTR), marks a significant milestone set to transform the conduct and oversight of clinical trials.

Read More
Becky Murphy Becky Murphy

Australian R&D Cashback & Early Development Activities

With demand for improved healthcare increasing globally, Australia is continuing to emerge as an attractive destination for the development of new and improved drugs and medical devices, driven by excellent research capabilities, a favourable Therapeutic Goods Administration (TGA) regime and an attractive Research and Development Tax Incentive (RDTI) regime.

Read More
Becky Murphy Becky Murphy

Introduction to EU Regulatory Affairs

In the European Union (EU) a network of approximately 50 regulatory authorities from the 30 European Economic Area (EEA) countries1, the European Commission (EC) and European Medicines Agency (EMA) form the basis of the European regulatory system and play a role in the authorisation and monitoring of medicines in this region.

Read More