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Showing posts from May, 2025

European Medicines Agency Confirms Biosimilar Medicines Can Be Interchanged Safely

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A biosimilar medicine is one that shows a high level of similarity to an existing approved biological medicine, known as the "reference product." Interchangeability refers to the practice of substituting one medicine with another, as long as the therapeutic effect remains consistent. In this case, it means replacing a reference product with a biosimilar that will provide the same clinical outcomes. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement, supported by an analysis of over a million patient-treatment years with no safety concerns raised. The statement confirms that once a biosimilar is approved in the EU, it can be substituted for the reference product or replaced by another biosimilar of the same reference product. Although several EU member states already allow such interchangeability, the joint statement aims to harmonize and standardize this practice across the EU. READ THE FULL BLOG   Know more about our Regu...

Key Developments & Implications of the European Health Data Space

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What is the European Health Data Space? In an era where data is often likened to oil in its value, the healthcare sector within the European Union holds a vast reservoir of untapped potential. Each day, enormous volumes of health-related data are produced across member states, offering transformative possibilities for the delivery, management, and advancement of healthcare. The European Health Data Space (EHDS) emerges as a bold initiative aimed at unlocking this potential. By granting patients greater control over their personal health information and fueling cutting-edge medical research, the EHDS is poised to fundamentally reshape healthcare across Europe. So, what does this mean in practical terms for patients, healthcare providers, and the future of medical innovation? Let’s delve into the core features and implications of the EHDS and examine how it’s laying the foundation for a more connected and healthier European community. The European Health Data Space (EHDS) is a dedicated ...

Why is QPPV Training the Key to Pharmacovigilance Success?

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Drug safety involves ensuring that the right medication is given to the right patient at the right time to enhance patient outcomes. A Qualified Person Responsible for Pharmacovigilance (QPPV) is key in overseeing the management of pharmacovigilance services and maintaining the quality standards of a pharmaceutical company. This individual plays a proactive role, guiding actions from establishing a pharmacovigilance system to acting as a point of contact for regulatory authorities' concerns. The role of a QPPV can vary, with some positions requiring a managerial focus and others requiring a more task-oriented responsibility. In addition to scientific expertise and medical knowledge, a QPPV must possess various skills to meet the goals of ensuring drug safety. READ THE FULL BLOG   Know more about our Regulatory Services in New Zealand To get the daily updates, follow us on: Facebook —  https://www.facebook.com/DDReg LinkedIn —  https://www.linkedin.com/company/ddregpharma/ Twitter —...

Regulatory Landscape for Biosimilars in Southeast Asia

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Regulatory Landscape for Biosimilars in Southeast Asia The biopharmaceutical landscape is at a pivotal moment as biosimilars—therapeutic products that closely resemble and are clinically equivalent to existing biologic drugs—gain traction. In Southeast Asia, a region characterized by diverse healthcare infrastructures and economic inequalities, biosimilars offer a transformative opportunity to enhance access to essential biologic therapies. Yet, their successful adoption into national healthcare systems depends heavily on regulatory readiness and cross-border alignment. As regulatory frameworks across the region continue to mature, it is essential for stakeholders—including pharmaceutical companies, regulatory professionals, healthcare providers, and policymakers—to grasp both the shared features and country-specific nuances of biosimilar approval pathways. In this blog, we examine the current biosimilar regulatory landscape in major ASEAN countries, highlight key challenges, and discu...

Overcoming Roadblocks in Global Pharmacovigilance Harmonization

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Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem”. Global Pharmacovigilance Harmonization, on the other hand, refers to the process of aligning regulations, practices, and standards across countries and regions in order to facilitate global collaboration and the cross-border exchange of information. However, achieving this goal is challenging due to the diversity of regulatory environments and scientific advancements.  Identifying Roadblocks to Pharmacovigilance Harmonization Achieving global harmonization in PV is crucial for reliable drug safety monitoring. However, this process is hindered by several barriers, including inconsistent regulatory requirements and cultural differences that influence how PV activities are implemented.    Differing Regulatory Requirements   Every country has the...