Regulatory Authorities
Below are summarizes on a selection of regulatory authorities for Australia, USA, EU and UK as these regions are prominent hubs for clinical research and regulatory oversight.
Depending on the target market for the new medical product, the applicable regulatory authority will vary so it is essential to engage with the relevant regulatory body to ensure compliance with local requirements.
Other globally recognized regulatory authorities that play significant roles in medical product development include;
Health Canada
Pharmaceutical and Medical Devices Agency (PDMA) Japan
National Medicine Products Administration (NMPA) China
Brazilian Health Regulatory Agency (ANVISA) Brazil
Therapeutic Goods Administration (TGA)
The TGA is Australia's regulatory authority who is responsible for overseeing the approval, safety and monitoring of therapeutic goods including medicines, medical devices and clinical trials.
Most new investigational drugs and medical devices require either a TGA clinical trial notification (CTN) or clinical trial exemption (CTE) before they can commence, depending on the risk and classification of the product.
The TGA's Clinical Trial Handbook provides guidance on conducting clinical trials in Australia using unapproved therapeutic goods.
https://www.tga.gov.au/resources/guidance/australian-clinical-trial-handbook
Food and Drug Administration (FDA)
The US FDA regulates new therapeutic medicines, medical devices and clinical trials to ensure safety, effectiveness and compliance with regulatory standards.
Most clinical trials being conducted in the US require FDA approval before they can commence. This is known as investigation new drug (IND) approval for new medicines or investigation device exemption (IDE) approval in the case of high-risk medical devices.
European Medicines Agency (EMA)
The EMA oversees the regulation of clinical trials across the EU, while individual EU member states approve and monitor individual trials, the EMA ensures harmonized standards and compliance with EU regulations.
The EMA evaluates and approves new medicines for use across the EU however, it does not regulate or approved medical devices.
Notified bodies are responsible for the assessment of medical devices while competent authorities in each EU member state are responsible for overseeing enforcement of medical device regulations within their jurisdiction.
https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices
Medicine and Healthcare products Regulatory Agency (MHRA)
The MHRA is the UK's regulatory authority responsible for ensuring the safety, efficacy and quality of medicines, medical devices and clinical trials.
The MHRA plays a critical role in overseeing the approval of new therapeutics and medical devices within the UK.
All new clinical trials involving investigational medicines, biological products and medical devices must be notified to the MHRA before they can commence.
https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk