In the rapidly evolving field of pharmaceutical development, time is of the essence. The ability to expedite the Regulatory approval process is crucial for meeting the urgent needs of patients, addressing unmet medical conditions, and maintaining a competitive edge in the market.
A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases. Combination products offer an innovative way of treating these diseases, as they can be delivered directly to the affected area, resulting in more effective treatment.
The core objective of post-market monitoring and vigilance is to enhance the well-being and safety of patients, healthcare professionals, users, and others by minimizing the occurrence of adverse events.
The monitoring of post-market performance aims to identify trends or issues that were previously undisclosed.
Complementary medicines play a significant role in healthcare in Australia; the Therapeutic Goods Administration (TGA) oversees them. Australians widely use these medicines, which include vitamins, minerals, herbal remedies, and other natural supplements, for various health purposes. The TGA ensures that these products are safe, effective, and high-quality.
Custom-made medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA). The TGA has changed the way of regulating custom-made medical devices in Australia, and the changes affect anyone who is manufacturing, importing, or supplying custom-made medical devices, including healthcare providers.
According to the Therapeutic Goods (Medical Devices) Regulations, 2002, a custom-made medical device is defined in the following terms:
The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the medical devices, Regulatory Affairs, and updated Regulatory information to design and implement a strategy can result in reduced costs, time-to-market, and maximum compliance.
The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization (AO) to conduct a single audit of a medical device manufacturer’s Quality Management System (QMS). It furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Aside from the participating Regulatory authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP.
Sunscreen is an important component of an effective sun protection regime. They must be safe, effective, and of good quality. For this reason, the TGA regulates sunscreens as therapeutic goods in Australia under the Therapeutic Goods Act 1989. The Australian Regulatory Guidelines for Sunscreens (ARGS) describe the Regulatory requirements and standards for sunscreens and their ingredients. As per the ARGS, sunscreens regulated under the Act are referred to as therapeutic sunscreens.
Sunscreens that fall under therapeutic goods are classified into:
To educate patients and Health Care Professionals (HCPs) and promote treatment options, the pharmaceutical industry like many other industries dedicates billions of dollars to advertise and promote prescription drugs. The legislative framework of advertising in Australia comes under Section 42BAA of the Therapeutic Good Act 1989. The Therapeutic Goods Advertising Code outlines the minimum requirements to be followed by the drug manufacturers while advertising therapeutic goods to Australian consumers.