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Pharmacovigilance, an essential procedure in healthcare, encompasses the identification, assessment, and prevention of adverse drug effects and other undesirable outcomes. Despite rigorous clinical trials conducted before medication release, some side effects may remain unidentified until after widespread usage. The National Pharmacovigilance Center of the Republic of Azerbaijan, operating under the Ministry of Health, plays a pivotal role in overseeing pharmacovigilance procedures. Citizens experiencing medication ineffectiveness or adverse effects are encouraged to report to the Analytical Expertise Center (AEC), facilitating thorough review and appropriate action. The AEC ensures patient safety by promptly addressing newly identified side effects and advising on reporting any adverse reactions, including those from traditional or alternative medicines. An increase in adverse event reports prompts governmental investigations, while strict confidentiality measures safeguard personal data. The AEC's systematic monitoring and evaluation, coupled with adherence to international standards and legal frameworks, contribute to enhancing drug safety. Regular updates on medication safety information are disseminated to healthcare professionals and the public, promoting informed medication use. Pharmacovigilance regulations, laws, and guidelines govern the AEC's operations, ensuring compliance and efficacy. Through collaborative efforts with healthcare institutions, the AEC conducts training to strengthen pharmacovigilance practices. Recruitment of pharmacovigilance representatives within medical facilities follows stringent criteria, emphasizing competence and timely reporting obligations. Overall, the AEC's vigilant oversight and proactive measures serve to optimize medication safety and uphold public health standards in Azerbaijan. [ABSTRACT FROM AUTHOR]

Pharmaceutical science encompasses meticulous processes, from initial pharmacological testing to distribution and pharmacovigilance. Each stage demands unwavering precision and adherence to regulatory standards to ensure the quality and safety of medicinal products. This article delineates the multifaceted landscape of pharmaceutical regulations, focusing on Good Manufacturing Practice (GMP) standards as a cornerstone of quality assurance. GMP standards, encompassing GxP principles, mandate adherence to rigorous protocols throughout the drug lifecycle. Within the European Union (EU), GMP standards are codified in directives and regulations governing medicinal products for human and veterinary use. Volume 4 of Eudralex serves as a compendium of EU regulations, providing comprehensive guidelines for pharmaceutical manufacturing. Mutual Recognition Agreements on GMP inspections between the EU and other jurisdictions aim to facilitate trade and regulatory cooperation, exemplifying international collaboration in pharmaceutical oversight. Recent agreements between the EU and the US FDA streamline inspection processes, reducing redundant inspections and expediting market access for pharmaceutical products. Moreover, electronic systems such as EudraGMDP enhance transparency and regulatory compliance within the pharmaceutical industry. By evaluating international GMP practices, this article underscores the importance of harmonizing regulatory standards for Good Manufacturing Practices globally. In conclusion, adherence to GMP standards not only ensures the quality of pharmaceutical products but also plays a pivotal role in the development of pharmacy practices worldwide. [ABSTRACT FROM AUTHOR]