The Australian pharmaceutical market is projected to experience a Compound Annual Growth Rate (CAGR) of 3% by 2028. In this dynamic landscape, pharmacovigilance plays a critical role in ensuring the safety and well-being of patients.
- June 20, 2023 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
- June 19, 2023 Pharmaceuticals, Regulatory Affairs
South Korea and the United States (US) have formed a high-tech collaboration to define global medical product standards. The goal of the partnership is to advance the usage of Artificial Intelligence (AI) medical products through joint workshops, as well as deepen the Korea-US high-tech alliance.
- June 19, 2023 Medical Devices
PMS is and importance for medical devices
Post Marketing Surveillance (PMS) is a key component of the regulatory framework for medical devices in India.
- June 19, 2023 Medical Devices
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.
- June 19, 2023 Medical Devices
With the transition in the European Union (EU) geography, from the Directives to the EU Medical Devices Regulations (MDR) 2017/745, significant changes have occurred in terms of rules and regulations. One such major change was observed in Annex I – General Safety and Performance Requirements (GSPR). In our previous blog, we deep dived into Chapter I and II.
- June 19, 2023 Medical Devices
The implementation of the In Vitro Diagnostic Regulation (IVDR) 2017/746 on May 26, 2022, has resulted in heightened scrutiny and Regulatory supervision for In Vitro Diagnostics (IVDs) in the European Union (EU).
- June 13, 2023 Medical Devices
From October 2023 onwards, the mandatory registration of Class C and D medical devices in India will require conformance with the Quality Management System (QMS) requirements, as per the Indian Medical Device Rules (IMDR) 2017. Thus, medical device manufacturers will have to implement a QMS that meets the requirements of Schedule V of the IMDR 2017.
- June 12, 2023 Pharmaceuticals, Regulatory Affairs, Regulatory Labeling
Introduction
Structured Product Labeling (SPL) is an essential component of the healthcare industry that provides a standardized format for drug information exchange among various healthcare systems. Labeling content must be presented in an electronic format for marketing applications. It must be submitted in a format that the United States Food and Drug Administration (USFDA) can process, review, and archive.
- June 12, 2023 Food and Food Supplements, Regulatory Affairs
Herbal medicines have been used for centuries as natural remedies for various health issues. However, there are varying regulations across different markets for the use of herbal ingredients. The global trend of incorporating herbal ingredients in medicines is gaining traction across the globe, with the projected value of the global herbal medicine market reaching USD 411.2 billion by 2026.
- June 12, 2023 Food and Food Supplements, Regulatory Affairs
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.