This unique study is the first in-depth analysis of the trends and changes in the regulatory approval times for medicines in the Kingdom of Saudi Arabia. Not only have the overall approval times been benchmarked for the years 1998 to 2003 but the times that products take to pass through the different stages in the review process have also been studied. This methodology, which identifies key ‘milestones’ in the review process for the purpose of calculating performance metrics, has allowed strengths and weaknesses of the regulatory procedure to be identified.
The data shows a steady decrease in the median approval times, by year of approval. This indicates that changes that have been introduced into the review procedures during the period of the study have had a beneficial effect on efficiency. These changes include reorganisation of the management structure and the increased use of information technology (IT).
The overall approval time varies considerably according to the location of the company submitting the application. Products from local companies have the fastest approval times, followed by companies in other Gulf Cooperation Council (GCC) States and Arab, non-Gulf countries, with products from international companies having the longest approval times.
The performance metrics for the different stages in the review process show that the scientific review is carried out relatively rapidly and accounts for only a small proportion of the total approval time, in most cases.
The study also highlights the fact that the analytical testing stage of the review process is the major rate-limiting step. The time taken to request samples and carry out analyses (including the time for companies to respond to questions) accounts for more than 50% of the total approval time for most products. This procedure is carried out sequentially rather than in parallel with other review activities and the outcome of the analyses show that the only problems detected are of a minor nature and the incidence is less than 1.5% of samples tested.