The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the central Regulatory authority that oversees medical device regulations in New Zealand.
- May 2, 2024 Medical Devices
- May 2, 2024 Medical Devices
The medical device Regulatory framework in New Zealand is built to ensure that medical devices sold in the country are safe and fit for their intended purposes. The Medicines Act, 1981 and its revisions, the Medicines Regulations, 1984, and the Medicines (Database of Medical Devices) Regulations, 2003 govern New Zealand’s medical device Regulatory system.
- April 30, 2024 Publishing & Submissions, Regulatory Software & Services
Governance on paper is designed around time and is continually evolving. New laws are born, standards evolve, and aligning with the ever-changing landscape gives the feeling of not catching up. However, an opposite situation is possible – foreseeing these changes; acting rather than waiting for the same to unfold; making you one step ahead of all your competitors.
- April 30, 2024 Pharmacovigilance, Regulatory Medical Writing
The world of medicine relies on a delicate balance between the effectiveness of drugs and their safety for patients. Pharmacovigilance, the science of monitoring drug safety, plays a crucial role in this equation. At the heart of pharmacovigilance lie the databases that store and analyze vital information on adverse drug reactions (ADRs).
- April 30, 2024 Pharmacovigilance, Regulatory Medical Writing
The journey of a drug from its conception to its entry into the global market is a complex and multifaceted process, fraught with challenges and governed by stringent regulations. Pharmacovigilance (PV) plays a critical role in this journey, ensuring that the safety and efficacy of pharmaceutical products are maintained at every stage.
- April 30, 2024 Pharmaceuticals, Compliance, Audit and Validation
GxP stands for "Good Practices," and the "x" can be replaced with various letters to denote specific areas, such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP), among others.
- April 30, 2024 Pharmaceuticals, Compliance, Audit and Validation
In the dynamic landscape of pharmaceuticals, ensuring product quality, safety, and regulatory compliance is paramount. A robust network of suppliers and vendors plays a crucial role in this ecosystem. However, the challenge lies in ensuring these partners meet the necessary quality standards and adhere to regulatory requirements.
- April 26, 2024 Medical Devices
The United States Food and Drug Administration (US FDA) released the highly anticipated revised Quality Management System Regulation (QMSR) in February 2024. The updated regulation serves as the new set of Good Manufacturing Practices (GMP) guidelines of the US FDA for medical devices, effectively replacing the previous set of Quality System Regulations (QSR).
- April 24, 2024 Publishing & Submissions
The journey of a new medicinal product from discovery to patient use is a complex one, requiring rigorous scientific evaluation and Regulatory approval. Regulatory Publishers play a crucial role in this process by preparing and submitting high-quality Regulatory documents to the relevant agencies.
- April 24, 2024 Pharmaceuticals, Publishing & Submissions
In the intricate world of pharmaceutical development and regulation, the role of regulatory submission professionals stands out as indispensable. These individuals serve as the guardians of compliance, the architects of documentation, and the liaisons between pharmaceutical companies and regulatory bodies.