SFDA is the regulatory body in Saudi Arabia that handles the registrations and approvals for products that are distributed in Saudi Arabia whether they are locally made or imported.
All product placements in the market require an SFDA certificate to protect the market from harmful, counterfeit and low quality products. This applies to a variety of products including drugs, cosmetics, food supplements etc.
Understanding the components of Drug registrations
At a minimum, you have to get familiar with the following aspects
- Understanding the Drug Classification done by SFDA
- Review the drug guidelines for different types of drugs such as human drugs, herbal or veterinary.
- Get familiar with the drug dossier requirements which includes New drugs, biosimilars, generic drugs etc
- Understand the drug registration application process submitted through the Saudi Drugs Registration (eSDR)
- Preparing for the process of submitting the eCTD for validation
Optional but recommended – SFDA Classification
is your product considered a drug, medical device or food?
Classification of the product determines if it falls under jurisdiction of the SFDA or any other regulatory body and if it is accepted to be marketed since homeopathic medicines for example are not allowed to be marketed in Saudi Arabia.
Also for borderline products, it is recommended to determine clearly what category this drug would fall in. A product classified as cosmetic in the country of origin might be classified as a drug in Saudi Arabia. The SFDA for example reclassified the hyaluronic acid injections as medical device products if no substantial claims or additional drugs are included. This classification at an early stage would save time, budget and rework.
What documents are needed to apply for SFDA classification?
Licensed Saudi Local companies can apply for SFDA classification by providing a set of documents as noted below
- Application form
- Detailed Product Information regarding composition and ingredients.
- Manufacturer Information & accompanying documents including letters
- Leaflet with the product information.
- Indication or purpose of use.
- Mechanism/mode of action.
- Countries in which the product is marketed
- Certificates: Registration in COO, GMP etc and present Conformity.
- The classification costs SAR1000 ($266.66) and takes 2 to 10 working days.
Once your product is classified, you can move to the next step to apply for registration.
Human Drug Registration
- The naming and graphic design of Medicinal Products
- Tamper evident packaging guidelines
- Adhering to Drug Master File (DMF) guidelines
- Drug Stability Guidelines including for example the Production and Quality Control of Vaccines
- Module 1 Specifications Guidelines for Bioequivalence
- SFDA SPC (Summary of Product Characteristics), PIL (Patient Information leaflet), and Labeling requirements
- Biosimilars and Biowaiver Guidelines
- Investigational New Drugs (IND) Requirements
- Pharmaceutical Reference Standard for the drugs
- Data required for Human Drugs Submission.
Herbal Drug Registration
- General Rules For Products Containing Vitamins And Minerals
- Data Requirements for Herbal & Health Products Submission including supplements.
- Guidance for Presenting PIL(patient Information Leaflet) and Labeling Information of Herbal and Health Products
Veterinary Drug Registration Guidelines
- VNeeS(non eCTD) specifications for the veterinary medicinal product
- Data Requirements for Veterinary Medicinal Products
- SPC, Leaflet, and Labeling for Veterinary Products.
Read more about the standards followed by SFDA.
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
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