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
Post-market safety data for underrepresented populations in clinical trials 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 »
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
Guidance on Informed Consent in Clinical Investigations Read More »
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
Diversity Plan in Clinical Trials Read More »
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
US FDA: Enhancing the safety of cosmetic products Read More »
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
Overcoming challenges in determining AI limits for NDSRIs Read More »
Navigating through API requirements to successfully register a drug product can be challenging, especially when these requirements are embedded in drug product regulations. This was indeed the case for Brazil where rules and regulations for APIs were very much available but were unclear as they formed a part of the drug product regulations rather than
Mandating CADIFA for drug registration in Brazil Read More »
The Center for Drug Evaluation and Research (CDER) of the US FDA outlined a program in February 2019 in which various stakeholders of the industry could propose pharmaceutical quality standards for recognition by the CDER. This would provide the industry with additional resources for the development and manufacturing of pharmaceuticals. In July 2023, the CDER
CDER: Creating efficiencies in pharmaceutical development and manufacturing Read More »
The rapid digitalization of the biomedical and clinical research sectors has ushered in a new era of advancements, with artificial intelligence (AI) taking centre stage as a transformative solution. In particular, AI is revolutionizing drug discovery processes by harnessing the vast amount of data generated during molecule screening phases and preclinical studies. As a result,
The Impact of Artificial Intelligence in the Lifecycle of Medicines Read More »
