ustralia’s Deputy Secretary for Health Products Regulation in the Department of Health John Skerritt has noted that in addition to managing significant increases in submissions of COVID-19 tests, disinfectants and personal protective equipment, and discussions with companies and researchers around potential and accelerated regulatory submissions for COVID-19 vaccines, the Therapeutic Goods Administration (TGA) has had a very busy time since the COVID-19 pandemic landed on our shores. These initiatives include managing the surge in medicines shortages since the COVID-19 crisis and continued reform in the product information, linked to the consumer medicines information, provided for over-the-counter medicines.

Teams to provide additional guidance about regulatory requirements and close support to new manufacturers and sponsors have been established. Rapid approvals of different design variations for ventilators and COVID-19 test kits for use by Public Health Laboratories have been granted, for example, with safeguards including post-market safety and performance reviews. The pandemic has also led to a large volume of complaints and reports alleging unlawful import, supply, and advertising of therapeutic goods in relation to COVID-19.

Monitoring and managing the significant upsurge in medicine shortages since the COVID crisis has been another heightened demand on TGA’s resources that unfortunately seems set to continue in 2020-‘21. Special focus has been directed to supply of medicines required to manage COVID-19 complications in patients admitted to Intensive Care Units. Rapid publication of targeted information for consumers and healthcare facilities to assist them with sourcing and safe use of these products have been a TGA priority.

In the ongoing non-COVID related work of TGA, a significant move to improve access to “up to date” information accompanying “over the counter” medicines (OTC), TGA-approved Product Information (PI) and the linked, but also TGA-approved, Consumer Medicines Information (CMI) can now be published on the TGA website. OTC products registered in the third Schedule (S3) are already obliged to have an accompanying PI and CMI that has been approved as part of the registration process. Additionally, S3 products require that pharmacists provide advice as part of the dispensing process. A pharmaceutical product includes the information accompanying it, and easy and reliable access to PI and CMI is critical to safe and effective use, so this is a welcome new national resource.

By the end of 2020, changes to the PI format that places critical information for health professionals such as indications, dosages and contraindications at the front of the document will be complete (the change-over process began in 2018). This reform now aligns Australian PIs with international regulatory formats.

On another topic, a safety advisory for the antihypertensive diuretic hydrochlorothiazide was gazetted by TGA on August 24. This drug is commonly found in combination products with ACE inhibitors, angiotensin II receptor antagonists, and calcium channel blockers. Epidemiological studies from Denmark, confirmed in an Australian study, identified increased risk of non-melanoma skin cancers, namely basal cell (BCC) and squamous cell (SCC) carcinomas, with significant odds-ratios up to five-fold for SCC of the lip. The propensity for photosensitivity with hydrochlorothiazide is thought to be related. PI and CMIs are being updated with advice for consumers to avoid ultraviolet exposure and to have regular skin checks.

There is increasing interest in faecal microbiota transplant (FMT) products. A proven indication is recurrent Clostridium difficile infection (CDI), most commonly a devastating complication of antibiotic therapy. Emerging indications include inflammatory bowel diseases, most notably ulcerative colitis, but there are many potential indications. After a period of consultation this year regarding the proposed new regulatory model, TGA has announced regulatory requirements for FMT. FMT encompasses products manufactured from frozen (stored) or fresh stool and introduced to the bowel for therapeutic purposes by any delivery method. Most FMT is now regulated as a “biological.” However, if a strain of microorganism known to be present in stool is grown from established isolates, the product may be regulated as a medicine. The microbiota is a fascinating new area of exploration in health and disease and there is much potential for therapeutic interventions.