Author name: development

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

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

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

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

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