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Pharmacovigilance

Strengthening Safety Compliance in Somalia

The National Medicine Regulatory Authority (NMRA) of the Ministry of Health regulates and controls regulatory & safety related operations for pharmaceuticals in Somalia. It is responsible for facilitating the availability and accessibility of safe and effective medicines to the Somalian population. More recently, the Somalian NMRA issued their very first Somali Pharmacovigilance Guideline with the …

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SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products

Efficiently detecting safety signals for veterinary products is crucial for safeguarding animal health and ensuring the well-being of both animals and humans. Rapid identification of potential risks allows for timely intervention, preventing widespread harm. Recognizing the significance of this, global authorities are actively working to fortify safety signal reporting. Establishing regulatory guidelines ensures a standardized …

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Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid

Pharmacovigilance in India has come a long way over the last few years especially for proactively detecting safety signals for pharmaceutical products. It is an indispensable component of the pharmaceutical industry in India, ensuring the safety and efficacy of drugs in the market. This comprehensive field includes various sub-categories, each contributing to the overall goal …

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Kenya’s Systematic Approach to Pharmacovigilance

Pharmacovigilance (PV) and drug safety surveillance activities rely on a robust PV system. This is important to effectively identify, evaluate, and address any adverse events (AEs) that are associated with medicinal products. Indeed, a proficient PV system facilitates data gathering that is critical for making informed decisions across various health systems. Regulatory agencies are reliant …

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ISoP: The Need for Patient Engagement in Pharmacovigilance

Pharmacovigilance is paramount for the well-being of patients exposed to pharmaceutical products. To ensure the effectiveness of pharmacovigilance systems professionals from various scientific disciplines contribute in diverse manner. Several organizations collaborate to ensure best global pharmacovigilance practices for patient safety. Among these key organizations is the International Society of Pharmacovigilance (ISoP) that is dedicated to patient …

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Ensuring Safe Use of Medical Devices in Healthcare Facilities

The safe and effective use of medical devices in healthcare facilities is not merely a matter of convenience; it is a moral obligation. The welfare of patients and the quality of healthcare services depend on the responsible use of these devices. Accidents involving medical devices can have dire consequences for patients. These accidents may result …

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CDER: Creating efficiencies in pharmaceutical development and manufacturing

The Center for Drug Evaluation and Research (CDER) of the US FDA outlined a program in February 2019 in which various stakeholders of the industry could propose pharmaceutical quality standards for recognition by the CDER. This would provide the industry with additional resources for the development and manufacturing of pharmaceuticals. In July 2023, the CDER …

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The Impact of Artificial Intelligence in the Lifecycle of Medicines

The rapid digitalization of the biomedical and clinical research sectors has ushered in a new era of advancements, with artificial intelligence (AI) taking centre stage as a transformative solution. In particular, AI is revolutionizing drug discovery processes by harnessing the vast amount of data generated during molecule screening phases and preclinical studies. As a result, …

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The Future of Certificate of Suitability

The Certificate of Suitability (CEP) to the monographs of the European Pharmacopoeia (Ph. Eur.) plays a crucial role in verifying the quality standards of active pharmaceutical ingredients (APIs). Issued by the European Directorate for the Quality of Medicines (EDQM), the CEP serves as evidence that an API complies with the rigorous quality requirements outlined in …

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