Freyr Solutions

  In April 2025, the New Zealand Ministry of Health released the   Tupu Ola Moui: Pacific Health Chart Book 2025 , a comprehensive two-volume report offering an evidence-based overview of the health status of Pacific peoples living in Aotearoa New Zealand. This publication is particularly relevant for pharmaceutical stakeholders—especially   Regulatory affairs teams, clinical development leads, and market access strategists —as New Zealand’s pharmaceutical regulation environment increasingly integrates health equity and cultural responsiveness into its approval and funding processes, driven in part by ongoing New Zealand health reforms. Official Report Announcement – Ministry of Health NZ Key Insights from the Chart Book Volume 1: Epidemiological and Public Health Data Titled  “Pacific Population in New Zealand” , Volume 1 presents: High-burden disease prevalence : Includes Type 2 diabetes, cardiovascular conditions, obesity, and chronic respiratory illnesses. Popula...

  China’s pharmaceutical industry is undergoing rapid transformation, driven by China's drug regulatory reforms aimed at accelerating innovation, improving patient access, and aligning with global standards. As we approach 2025, three key Regulatory changes could reshape the market, impacting drug approvals, pricing, and commercialization strategies, especially for those navigating the drug approval process in China and adapting to evolving China pharmaceutical regulations. Here’s what pharma companies, investors, and Regulatory professionals need to know:  1. Expanded Use of Real-World Evidence (RWE) for Drug Approvals  What’s Changing?  China’s National Medical Products Administration (NMPA) is increasingly accepting Real-World Evidence (RWE) to support China drug approval, particularly for rare diseases, oncology, and post-marketing studies. In 2023, the Center for Drug Evaluation (CDE) released updated guidelines encouraging RWE in Regulatory decision-making to s...

  Artificial Intelligence (AI) is rapidly transforming healthcare, revolutionizing diagnosis, treatment planning, and patient care. Among the most impactful advances is AI’s role in medical imaging and diagnosis, especially in radiology, pathology, and oncology. By integrating diverse data sources—including medical images, electronic health records (EHRs), and genomics—AI-driven multimodal approaches enable clinicians to detect diseases earlier and tailor treatments with unprecedented precision. This blog explores how AI is reshaping healthcare, its challenges, and the need for ethical and technical frameworks to ensure its responsible implementation. The Power of Multimodal AI in Medical Imaging Medical imaging modalities such as X-rays, CT scans, MRIs, and pathology slides provide critical insights into patient health. Traditionally, interpretation depends on expert human judgment, which, while invaluable, is subject to variability, workload constraints, and the increasing volume...

  In today’s rapidly evolving healthcare landscape, how scientific information is communicated matters more than ever. Medical and scientific content curation is not just about gathering and presenting data; it’s about transforming complex research into transparent, compliant, and engaging messages tailored to specific audiences. Whether the aim is to drive product awareness or to educate on complex processes, understanding how to curate both promotional and non-promotional material is key to building trust and fostering informed decision-making. The Dual Nature of Healthcare Communications At the heart of effective communication in the medical and scientific field lies a balance between promotion and information. Promotional materials are designed to highlight the benefits of a product, service, or therapy, often directing messages towards product awareness, brand differentiation, or engagement with healthcare professionals (HCPs) and patients. In contrast, non-promotional materia...

  INVIMA has launched an exceptional plan to unblock thousands of regulatory procedures in Colombia. If your company is in the process of obtaining a marketing authorization, this is essential information. While it doesn’t introduce immediate regulatory changes or set new official timelines, the plan signals the beginning of an operational transition: a phase aimed at enhancing INVIMA’s responsiveness, optimizing internal workflows, and reducing backlogs. For pharmaceutical companies —both local and international— this represents a  tactical window to move forward strategically, gain competitiveness, and accelerate market entry . WHAT DOES THIS PLAN MEAN FOR PHARMACEUTICAL COMPANIES? The  Contingency Plan  does not replace existing regulations or redefine processing timelines. However, Resolution 2025010547 does introduce concrete measures such as: Redistribution of technical staff Extended working hours Prioritization of backlogged submissions These actions could tr...

  INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the entity responsible for the surveillance activities of medicines in Colombia, and   new regulation has recently come into effect, impacting all Marketing Authorization Holders (MAHs)   . Here’s what every MAH should know Pharmacovigilance System Master File (PSMF): MAH must establish a PSMF describing the pharmacovigilance activities, responsibilities, and verification activities performed for the marketed products; this file must be available in Spanish. In addition to the documentation framework, INVIMA has emphasized the importance of having a qualified local representative, as follows. Appointing a Local Person Responsible for Pharmacovigilance (LPPV): MAH must nominate a LPPV before INVIMA; this person must be a physician or pharmacist, reside in the country, and be available permanently and continuously. This person will be the point of contact for safety matters related to the m...