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 […]
Japan PMDA: The Role of In-Country Clinical Caretakers Read More »
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
Regulatory Framework for Cosmetics in South Korea Read More »
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
Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making Read More »
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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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
Evaluating the need for comparative clinical efficacy studies in biosimilar development Read More »
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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During an inspection, the US FDA may detect that the manufacturer has violated a significant number of regulations. These could be low-quality manufacturing processes, issues regarding product claims, and even incorrect directions for use. In this case, the FDA notifies the manufacturer of the same by way of a Warning Letter which, in addition to
Requesting Post-Warning Letter Meetings Read More »
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
UK MHRA International Recognition Procedure Read More »
Saudi Food and Drug Authority’s Requirements on Child-Resistant Packaging for Medications Posing Substantial Toxicity Risk. Introduction: The Saudi Food and Drug Authority (SFDA) stands as an unwavering guardian of patient safety in the Kingdom of Saudi Arabia (KSA). Renowned for its commitment to stringent and meticulous regulatory practices within the GCC region, the SFDA has
Packaging Requirements for the Safety of Children Read More »
A marketing authorisation application (MAA) can take up to 210 days in which EMA experts spend time to assess the information provided by the applicant which supports their MAA. This period can be interrupted by ‘clock-stops’ where EMA’s Committee for Medicinal Products for Human Use (CHMP) can raise questions that the applicant must address. Oral
How to prepare for oral explanations with EMA Read More »
