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Regulatory

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

Blogs, Regulatory /

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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Modernization of Cosmetics Regulation Act

Blogs, Regulatory /

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a significant milestone in the regulation of cosmetic products in the United States. This comprehensive legislation, enacted to enhance consumer safety, imposes a series of requirements and obligations on cosmetic companies, facilities, and responsible persons within the industry. MoCRA not only expands the authority of

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Evaluating the need for comparative clinical efficacy studies in biosimilar development

Blogs, Regulatory /

Introduction Long-term safety, efficacy, and immunogenicity data of licensed biosimilars do not raise concerns. State-of-the-art analytical and functional testing, as well as robust pharmacokinetic (PK) and pharmacodynamic (PD) studies are sufficient to demonstrate biosimilarity. In in-vivo animal studies and large confirmatory efficacy and safety studies are generally not needed. This blog provides and overview on

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Prescription-Drug-Use-Related Software

Blogs, Labeling, Regulatory /

Introduction With the advancement in digital technology, the development of prescription drug use-related software has surged, offering innovative solutions to enhance patient care, monitor drug adherence, and improve healthcare outcomes. The U.S. Food and Drug Administration (FDA) recognized the need to address software outputs related to prescription drugs and combination products. Prescription drug-use-related software is associated

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UK MHRA International Recognition Procedure

Blogs, Regulatory /

The UK MHRA’s Latest Update on the International Recognition Procedure Introduction The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has taken a significant step towards enhancing its regulatory processes. The reason behind this step is to facilitate medicine access by expediting their approval. The MHRA has recently released comprehensive guidance on

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