A GaBIJ Review Article entitled ‘Trends in Saudi FDA drug approvals and GMP inspections: an observational study’, was published by a group of authors, Alhomaidan et al., from Saudi Food and Drug Authority (SFDA) in October 2023 [1].
Saudi FDA drug approvals and GMP inspections: trend analysis
Generics/Research | Posted 22/05/2024 0 Post your comment
The pharmaceutical landscape in Saudi Arabia has witnessed significant growth in the past decade, with a surge in the number of approved medications and active ingredients. Regulatory bodies like the SFDA play a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products through stringent oversight and inspections.
Alhomaidan et al., discuss the importance of regulating pharmaceuticals to prevent the use of unsafe or ineffective medications, which can have serious health implications. SFDA, established to oversee the pharmaceutical sector in Saudi Arabia, is responsible for ensuring the correctness, quality, safety, and efficacy of medicines, as well as regulating manufacturing facilities and the registration of products.
Good manufacturing practices (GMP) inspections are a key aspect of SFDA's regulatory activities, aimed at assessing compliance with international quality standards. The authors examine trends in SFDA approvals and GMP inspections from 2011 to 2020, highlighting the increasing number of medications approved annually and the common deficiencies found during inspections.
One significant finding is the reduction in review timelines by SFDA, which enables pharmaceutical companies to bring their products to market more quickly. However, despite improvements in review times, deficiencies identified during inspections remain a concern. The authors present data on the most frequent deficiencies observed, including issues related to production, premises and equipment, quality control, and personnel.
The discussion delves into specific chapters and annexes of GMP regulations where deficiencies are commonly found, such as production, premises and equipment, quality control, and validation. It emphasizes the importance of addressing these deficiencies to ensure the quality and safety of pharmaceutical products.
Furthermore, the article underscores the need for continuous improvement and training within pharmaceutical manufacturing facilities. By analyzing inspection reports and identifying common sources of errors, manufacturers can develop targeted training programme to address deficiencies and enhance product quality.
In conclusion, Alhomaidan et al. highlight the importance of regulatory oversight in ensuring the safety and efficacy of pharmaceutical products in Saudi Arabia. By addressing common deficiencies and investing in training initiatives, manufacturers can improve compliance with regulatory standards and maintain high-quality standards, ultimately benefiting public health and the reputation of the pharmaceutical industry.
Related articles
GMP certification requirements in Argentina, Brazil and Mexico
Biopharmaceuticals and biosimilars: regulatory challenges for global harmonization of GMP standards
Global harmonization of GMP standards for biologicals
LATIN AMERICAN FORUM View the latest headline article: Bio-Thera y SteinCares firman acuerdo para comercializar dos biosimilares en LATAM Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO Ver el último artículo de cabecera: Bio-Thera y SteinCares firman acuerdo para comercializar dos biosimilares en LATAM !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. |
Reference
1. Alhomaidan AM, Alageel MA, Alrafie TA, et al. Trends in Saudi FDA drug approvals and GMP inspections: an observational study. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(3):78-86. dot: 10.5639/gabij.2023.1203.013
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Generic medications in the Lebanese community: understanding and public perception
Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
Comments (0)
Post your comment