Saudi Food and Drug Authority (SFDA) is the key Drug Regulatory Authority in Saudi Arabia. Drug department of the SFDA is responsible for handling and licensing of the manufacture, import, export, distribution, promotion, and advertising of medicinal products. SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and for monitoring the quality & safety of the marketed medicinal products.
Medicinal Product Classification
In the KSA, medicinal products are classified into following categories:
- New Drug/New Chemical Entity
- Generic Drugs
- Biological Drugs
Medicinal Product Registration
A) Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
Applicant should register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
- The applicant shall apply through the Saudi Drug Registration (SDR) system to fill the application form and to pay the fees.
- Upload the eCTD file to the system through the SDR system portal. Soft copy of the eCTD should be submitted in three (03) CDs labeled as per the SFDA guideline, along with the hard copies of the original documents (like cover letter, CPP, application form).
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 –Assessment, Testing and Inspection
MAA will be evaluated by the relevant departments to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3- Pricing
The Pricing department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
B) Verification and Abridged Procedure
This process will be applicable if the product has been approved and marketed by both the EMA and the US FDA.
This process will be applicable if the product has been approved and marketed by either the EMA or the US FDA.
C) Waiver of Onsite GMP Inspection
Onsite GMP inspection can be waived if the manufacturing facility is approved by the Gulf Cooperation Council – Drug Registration.
D) Importance of Local Entity for a Foreign Manufacturer
For any foreign medicinal product manufacturer, it is mandatory to have an authorized representative in Saudi Arabia for administrative support and for Regulatory communication with the SFDA.
E) Importation of Non-Registered Product
SFDA allows importation of non-registered products for the cases mentioned below:
- Essential drugs
- Drugs for which substitutes are not available in the Saudi market
However, before importation, the local agent must obtain an import permit for each shipment from the Agency.
Product Maintenance & Compliance
Validity for Registration Certificate
Five (05) years from the date of registration
Renewal of Registration Certificate
The renewal application should be submitted six (06) months before expiration of the existing registration certificate
Post-approval Changes (Variations)
Any change of registered medicine should be sent to the SFDA with relevant documents, case-by-case basis.
- End-to-end Pharmaceutical Product Registration
- Authorized Local Agent Support
- GMP Support
- Dossier Gap Analysis as per the SFDA Regulatory Requirements
- Preparation of Gap Analysis Report and Remediation Plan
- Pharmaceutical Dossier Preparation and Submission to the SFDA
- Query Support Management until Approval
- Pharmaceutical Life Cycle Management Support
- Ad-hoc Regulatory Affairs Consultation