2.1. Epidemiological Data
Information on the disease, its prevalence, incidence, targeted population, no. of patients both globally and in Saudi Arabia are required to be documented within the submission file to the SFDA.
2.2. Market Share
Refers to the proportion of the pharmaceutical product sells in volume and value compared to the total number of alternatives used in treating the same condition. Information on the current market share of the product in Saudi Arabia are required to be documented in the submission file to the SFDA. In case of a new product, the estimates of the market share for the upcoming five years are required to be documented.
2.3. Drug Marketing Plan
Drug marketing plan refers to the targeted segment of healthcare in Saudi Arabia that the product is mainly distributed in. Information on the targeted segment should be presented in the submission file to the SFDA. It could be one or more of the following:
Tender Item only
Retail Pharmacy only
Public (whole market)
Prescription only medicine
Controlled prescription medicine
Pharmacist only medicine
Over the Counter (OTC)
2.4. Access Agreements
Access agreements defined as arrangements between the healthcare institution and the company that allow for controlling the cost of medicines while managing uncertainty around their financial impact or performance. There are two main types of agreements:
• Financial Agreements: aim to manage uncertainty around the budget impact of a technology.
• Outcome Agreements: the analysis of data on product performance, with payment contingent on the collection of data and/or on the outcomes achieved.
The applicant must clearly state the type of access agreements planned for Saudi Arabia and present it to the SFDA upon registration. If any changes in the access agreement happened later, the applicant must notify the SFDA at the time of the nearest updated submission or when required whichever is the nearest.
It is worth noting that there are considerations when applying for access agreement, including the following:
- Compliance with the agreement is essential, as a commitment letter should be submitted from the company.
- SFDA can suggests alterations on the access agreement proposed by the manufacturers given the stakeholders input.
2.5. List of Published EES’s and Health Technology Assessment Decisions
Information on the published EES(s) are required to be documented in the submission file to the SFDA showing the following information (title, disease area, time horizon, method of analysis, model used, comparators, cost measure, outcomes measure, results, and conclusion). In addition, a summary conclusion from the following Health Technology Assessment (HTA) agencies are required to be presented such as The National Institute for Health and Care Excellence (NICE), Institute for Clinical and Economic Review (ICER), Canadian Agency for Drugs and Technologies in Health (CADTH), Haute Autorité de santé (HAS), Therapeutic Goods Administration (TGA)…etc.