In this post, we outline the SFDA drug registration requirements and clarify the approval process for those seeking drug approval in Saudi Arabia. We will cover different drug application types and their requirements to help you understand the entire SFDA drug registration process.
For other types of products, you may refer to:
The Saudi Food and Drug Authority (SFDA) regulates pharmaceutical products in Saudi Arabia and determines drug registration requirements and post-marketing obligations. These requirements have evolved significantly since 2009, when SFDA adopted the ICH guidelines. The submission particulars have significantly transitioned from the paper format to CTD, then NeeS, and finally to the current eCTD dossier. Therefore, to help you prepare the drug file requirements, it is also essential to understand the details of the lengthy registration process.
The best practice when preparing for the SFDA submission is to develop a regulatory strategy. This strategy is necessary for accurate business decisions and a smooth registration process. It provides the needed visibility on the forthcoming regulatory impact on all functions.
Since compliance and registration requirements are the foundation of the regulatory strategy, having it developed before starting the registration process will eventually contribute to your project’s positive progress and make its execution more effective and reliable. Read: How to Develop a Regulatory Strategy for the Saudi Market.
The most common question I receive is, “What are the SFDA registration requirements?” This question is tricky to answer with a confined checklist. Every required document has its specific compliance measures, let alone the needed comprehensive due diligence that goes beyond the drug file.
Therefore, the information provided here enables regulatory professionals to discover the depth and length of the requirements. In this direction, I segmented such interconnected processes into four sections:
According to the drug type, you will find below the related SFDA drug registration guidelines:
Applicants must fill out the drug registration application and submit it through the Saudi Drug Registration (eSDR) system. It is a web portal available for local Saudi companies; it enables the applicants to do the following:
Drug applications in eSDR come in three major types with more sub-types, as follows:
There is a matrix of fees related to drug registration, which we detailed in our post: SFDA Fees.
The following image shows the application submission process, which involves two layers of validations.
The SFDA receives the submitted dossier and performs an electronic validation on the compiled eCTD according to the SFDA eCTD Validation Criteria.
This evaluation stage is a manual validation performed on the file after passing the electronic validation. It is a step before the initiation of the actual evaluation. It aims to reduce the number of obvious file deficiencies usually discovered during the evaluation process.
The SFDA will validate (not evaluate) the presentation and main compliance issues such as:
The drug sector has different assessment timelines depending on the application type and whether the product has acquired registration approval in a reference country. Read SFDA timelines.
We find it essential to understand the SFDA approval process, namely the scientific assessment and the application journey through the drug sector departments. Knowing those details is necessary so we can put the registration requirements into context and help you determine which evaluation stage your application is at.
The drug approval process consists of multiple parallel evaluation routes within the drug sector. The parallel assessment allows departments to assess the application simultaneously. Below, we will go through each evaluation route in more detail.
The inspection department is responsible for evaluating, inspecting, and granting the SFDA GMP approval for drug manufacturers. Applicants should expect mandatory GMP licensing for all drug, health, herbal, and veterinary manufacturers. The licensing process includes a physical site inspection by SFDA inspectors and payment of the inspection fees.
During the SFDA drug registration, you should expect a request for analysis samples and reference standards. Sometimes, you may be able to waive this request until the arrival of the first commercial batch to the Saudi market.
The pricing evaluation is the last SFDA drug registration stage. It is not parallel to the other assessments. This department performs a pharmacoeconomic study on the drug and generates a report for the SFDA pricing committee. The committee will set the CIF price and ask the applicant to accept or appeal.
The SFDA’s registration committee reviews all departments’ final comprehensive evaluation report and then issues the formal approval or rejection decision.
Approved drug applications will receive a registration certificate that entitles the company to market in Saudi Arabia. The validity of this certificate is five years.
After we understand that the drug application will go through an extensive assessment by SFDA experts, the applicant should expect multiple waves of inquiries (RFIs) during the process, especially on the API, stability, clinical trials, bioequivalence, labelling (PIL/SPC), pharmacovigilance system, and QPPV.
Whether it’s an administrative or technical change to the drug file, the SFDA must review and approve the variation application before the applicant markets the product. Read more: SFDA Variation Guidelines Overview.
Companies must maintain the drug license’s validity at all times. When it is nearing expiry, they must submit a renewal application. Submission is allowed six months before the expiration date.
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