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 …
Comprehending the Key Components of Formal Meetings for Biosimilar Development with the FDA Introduction The development and approval process for biosimilar or interchangeable biosimilar product development is a complex journey. It requires close collaboration between pharmaceutical companies and global regulatory consulting authorities. In the United States, the Food and Drug Administration (FDA) plays a pivotal …
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Navigating the Paediatric Investigation Plan and its Significance in the Development of Medicinal Products. The development and authorization of medicinal products for paediatric use are essential for ensuring the health and well-being of children. However, conducting clinical trials involving children requires a distinct set of considerations and ethical standards. To address these challenges, the concept …
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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 …
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Introduction Regulatory agencies require sponsors to collect and provide data on the safety and efficacy of drugs that they have obtained from clinical trials. In addition to age, gender, and racial subgroups, these trials should also incorporate data on patient populations that are historically underrepresented in clinical research. Indeed, information from a diverse patient population …
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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 …
Within the realm of clinical research, the process of obtaining informed consent stands as a crucial cornerstone of ethical practice, serving to protect the rights and well-being of human participants. The U.S. Food and Drug Administration (FDA) recognizes the changing landscape of clinical investigations and the necessity to align with the 2018 Common Rule and …
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The importance of recruiting diverse patients for clinical trials in pharmaceutical development and approval has been highlighted by various stakeholders. Regulatory agencies have been proactive in establishing policies and providing guidelines. These promote practices which support diversity in clinical trials to ensure greater population representation. An example is the US FDA’s Racial and Ethnic Diversity …
In the ever-evolving landscape of personal care and aesthetics, cosmetic products have risen to prominence and have wielded significant influence over individual and societal perceptions of allure. Yet, the journey from development to commercialization is underpinned by a complex tapestry of regulations designed to ensure consumer safety, uphold product integrity, and govern industry practices. In …
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Introduction Nitrosamine Drug Substance-Related Impurities (NDSRIs) share structural similarity with API and are therefore unique to every APIs. Drug products containing API that have 2° or 3° amines, when mixed with excipients that have the ability to cause the nitrosation reaction, are responsible for the formation of NDSRIs. There is often a lack of mutagenicity …
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