P232: Trends in Saudi FDA Drug Approvals and GMP Inspections: An Observational Study

Poster Presenter

Ali M Alhomaidan

Consultant
The Saudi Food And Drug Authority
Saudi Arabia

Objectives

In this paper, we discuss the most prevalent GMP inspection deficiencies noted, explore the evolution of laws and standards that impact drug regulation, delineate the changes in the number of drugs approved from 2011 to 2020, and expand the role and authority of the Saudi FDA.

Method

All medications that the Saudi FDA approved were identified and examined for this investigation. We reviewed all items registered between 2011 and 2021. Additionally, the deficiency data pattern from the GMP inspections between 2018 and 2021 were examined.

Results

The total number of days required by the SFDA to examine new medications climbed from 191 days in 2011 to 325 days in 2016; however, it then rapidly decreased to 119 days in 2021. The total number of days required by the SFDA to assess biologicals climbed from 66 in 2011 to 378 in 2016, and then fell to 105 in 2021. For all cycles of review, the SFDA review times for generic pharmaceuticals grew from 101 days in 2011 to 409 days in 2015 and then decreased once again to 109 days by 2021. Over time, the SFDA's list of approved items has grown significantly. There were 214 new medications licensed in 2021 compared to 21 in 2011. With the number of generic pharmaceuticals approved annually rising from 59 in 2011 to 533 in 2021, the generic drugs pathway has been extensively employed. From 4 items in 2011 to 86 in 2021, the number of approved biologics also grew. The trend of GMP inspections along with all classifications of deficiencies found in the top 7 chapters and annexes between 2018 and 2021 is observed. This data was derived from the GMP inspection reports. Between 2018 and 2021, the following, in order of frequency, are the most typical GMP flaws: Production, premises and equipment, quality control validation, materials management, quality management, and personnel.

Conclusion

A careful design of regulatory requirements, their correct implementation, and an evidence-based assessment of whether such initiatives are actually beneficial to the public are necessary to strike the right balance between rapid development and rigorous evidence-gathering. In a perfect world, regulatory and incentive structures would be based on quantitative measures of actual therapeutic value relevant to patients, and these metrics would be reported in a straightforward and objective manner. The degree to which those medications improve or impair patient well-being, including the effects of high prescription expenditures, is ultimately what determines whether the system for drug approval is successful.