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Kenya’s Systematic Approach to Pharmacovigilance

All Category, Blogs, 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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MHRA’s AI-Airlock for Safe Development of Medical Technologies

All Category, Blogs, Medical Device /

The use of artificial intelligence (AI) in the Pharmaceutical and Health Care industries has paved the way for more innovative opportunities to help enhance patient outcomes. This is with respect to the diagnosis, treatment, and overall personalized patient care. However, as these technologies evolve, so do the challenges especially when it comes to testing these

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Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices

All Category, Blogs, Medical Device /

As more artificial intelligence (AI) and machine learning (ML) technologies become increasingly available, the uniqueness of medical devices also evolve. Though AI/ML-driven devices provide support for diagnosing and treating more complex conditions, their unique features highlight the need for a more harmonized approach towards device regulation for patient safety. Regulators across the globe are gradually

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ISoP: The Need for Patient Engagement in Pharmacovigilance

All Category, Blogs, 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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AMDF: Ensuring the Safety of Donated Medical Devices

All Category, Blogs, Medical Device /

In times of emergencies like war, disease outbreak, natural disasters etc that lead to a rise in casualties, humanitarian support such as donations may be required. These donations can range from basic items like clothing to more technical complex items such as medical devices. While donations can be crucial during emergencies, they also bring challenges

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Japan PMDA: The Role of In-Country Clinical Caretakers

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Japan has a robust regulatory framework for pharmaceuticals and medical devices, which includes specific requirements for In-Country Clinical Caretakers (ICCC). Foreign manufacturers that wish to penetrate the Japanese market must appoint an ICC, who resides in Japan, to sponsor the clinical trials on their behalf. Thus, they play a crucial part in ensuring that foreign

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Regulatory Framework for Cosmetics in South Korea

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The cosmetics sector in South Korea has witnessed impressive expansion and gained global acclaim. The Ministry of Food and Drug Safety (MFDS) has implemented a strong regulatory system, primarily overseen by the Cosmetics Act, to guarantee the safety and quality of cosmetic items. The Cosmetics Regulatory Framework, in conjunction with additional regulations, plays a crucial

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Pharmacovigilance in Herbal and Alternative Medicine

All Category, Blogs, Pharmacovigilance /

At the turn of the millennium, guidelines for post-marketing safety reporting of herbal medicines were introduced by the World Health Organization (WHO) in the period between 1999 and 2001. The fact that more than 158 million people in the United States alone spent over 17.6 billion dollars on herbal medicines in the year 2000 is

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Supporting Labelling Compliance with Searchable Databases

All Category, Blogs, Labeling /

Biopharmaceutical product labelling is a multifaceted undertaking that spans various products and markets, encompassing diverse formulations and dosages.  The challenge lies in consistently upholding pharmaceutical labelling compliance throughout this intricate process. Ensuring pharmaceutical labelling compliance involves following regulatory requirements and guidelines when developing and updating product labels, such as Summary of Product Characteristics (SPC), Patient

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Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making

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Real-World Evidence (RWE) refers to clinical evidence derived from real-world data (RWD) collected outside of traditional clinical trial settings. The significance of RWE in regulatory decision making has been growing worldwide due to its potential to provide valuable insights into the safety, efficacy, and effectiveness of therapeutic products. While traditional clinical trials remain the gold

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