The pharmaceutical industry finds itself amidst a dynamic and ever-evolving Regulatory landscape in 2024. Navigating these shifting currents necessitates a focus on compliant and effective artwork, which serves as a critical tool for ensuring both Regulatory adherence and brand success.
- March 5, 2024 Regulatory Artwork Services
- March 5, 2024 Publishing & Submissions, Regulatory Software & Services
In a recent development, the Therapeutic Goods Administration (TGA), Australia has updated its guidance document titled “eCTD AU Module 1 & Regional Information,” making crucial changes to Module 1 v3.1 while adopting the International Council for Harmonization’s (ICH) electronic Common Technical Document (eCTD) v4.0 specification.
- March 4, 2024 Food and Food Supplements
Singapore’s food industry is currently undergoing a major Regulatory transformation, particularly with respect to infant nutrition. The Singapore Food Agency (SFA) has proposed a set of amendments, with a specific focus on infant formula additive regulations, aiming to elevate the safety and quality standards of infant nutrition products.
- March 4, 2024 Medical and Scientific Communication
In the pharmaceutical and healthcare domains, advertising or promoting the products is vital yet challenging due to the regulatory complexities that pharmaceutical companies must handle.
- February 29, 2024 Pharmaceuticals, Regulatory Affairs
Are you stepping into the world of pharmaceuticals in Brazil? Have you ever wondered how medicinal products /drugs are approved in the country? Get ready as we unveil thirteen (13) must-know Frequently Asked Questions (FAQs) on the drug approval process in Brazil.
- February 27, 2024 Medical Devices, Regulatory Affairs
Clinical trials form a critical phase in the development and approval of medical devices. They provide the necessary evidence to demonstrate the safety and efficacy of a device before it can be marketed. The United States Food and Drug Administration (US FDA) sets stringent requirements for conducting clinical trials to ensure that the data collected are reliable and that patient rights are protected.
- February 27, 2024 Medical Devices, Regulatory Affairs
As a medical device manufacturer, you must understand and prepare for the United States Food and Drug Administration’s (US FDA’s) inspections to maintain compliance and ensure that your medical device can be marketed and distributed without legal impediments. The US FDA’s Regulatory oversight includes ensuring that devices are safe, effective, and meet the necessary quality standards.
- February 22, 2024 Pharmaceuticals, Regulatory Labeling
In the pharmaceutical industry, patient safety is a top priority, and advancements in technology are being leveraged to improve the accessibility and comprehensiveness of product information. One such technological innovation that holds great promise for enhancing patient safety is the implementation of QR codes in pharmaceutical labeling.
- February 22, 2024 Pharmaceuticals, Regulatory Labeling
The pharmaceutical industry operates within a highly regulated environment, where compliance with global Regulatory labeling requirements is paramount. As we look to the future, several key trends and developments are poised to shape the Regulatory labeling landscape, presenting both opportunities and challenges for pharmaceutical companies.
- February 22, 2024 Food and Food Supplements
Introduction
The European Union (EU) has implemented groundbreaking regulations for wine labeling, which have been effective from December 08, 2023. The regulations are applicable to wines manufactured from the 2024 harvest onward. These regulations aim to enhance consumer information by requiring detailed labels, including ingredient lists and nutritional values.