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Advancing Healthcare through Electronic Product Information

Blogs, Labeling, Regulatory /

Electronic Product Information (ePI) is authorized, statutory information for medicines, covering patient information leaflets and the Summary of Product Characteristics for healthcare professionals. It adheres to a semi-structured format with the common EU electronic standard, optimized for electronic handling, internet dissemination, and compatibility with healthcare information systems. Despite print options, the primary aim of ePI […]

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How is EMA Addressing Medicine Shortages in Europe?

Blogs, Regulatory /

The emergence of drug shortages as a significant global health concern is evident. Organisations including the European Medicines Agency (EMA) express concerns about long-term medicine availability, emphasizing the need for continuous access to high-quality, affordable essential medicines.  Shortages lasting days or months jeopardize patient outcomes, straining healthcare systems. EMA has introduced a solidarity mechanism, developed

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Kenya’s Systematic Approach to Pharmacovigilance

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

Blogs, Medical Device, Regulatory /

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

Blogs, Medical Device, Regulatory /

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

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

Blogs, Medical Device, Regulatory /

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

Blogs, Clinical Regulatory, Regulatory /

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

Blogs, Regulatory /

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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