Saudi Arabia Drug Product Registration

Drug Process Registration

1. Pre-Submission Activities

Before submitting a new medication application, companies often engage in pre-submission activities, such as meetings with the SFDA to explain requirements and answer questions.

2. Documentation and Application Submissions

Create a complete dossier that includes scientific, technical, and regulatory information regarding the new drug. This information is submitted to the SFDA as part of the new medication application.

3. Technical Review

The SFDA undertakes a rigorous technical assessment of the supplied documentation to determine the safety, effectiveness, and quality of the new medicine. This involves a review of clinical trial results, manufacturing methods, and other pertinent information.

4. Clinical trials

If the new drug has undergone clinical trials, the SFDA examines the trial results to determine its safety and efficacy.

5. Risk Management and Pharmacovigilance

Companies must establish risk management and pharmacovigilance plans to monitor and manage any adverse effects that arise after the medicine is released to the market.

6. Approval Decision

Based on the review and inspections, the SFDA decides whether to approve the new drug. If approved, the drug may be granted marketing authorization.

7.  Post-Market Surveillance

After approval, the SFDA continues to monitor the safety and efficacy of the drug through post-market surveillance activities. This includes ongoing safety reporting and inspections.

Registration of Generics

 1. Application for Product Registration

Submission of the ANDA in the format of eCTD. The first step is to prepare and submit the ANDA, which is a regulatory submission for generic drugs. The eCTD format is an electronic submission standard that organizes drug information consistently for regulatory authorities.

 2.Technical Validation

Validation of the Technical Data in the eCTD. Regulatory authorities will validate the submitted eCTD to ensure that all needed technical data, such as information on the drug’s formulation, manufacturing process, and quality control, is present and meets regulatory criteria.

 3.Bioequilvence Assessment

The assessment of the Bioequilvence data. Bioequivalence studies are critical for generic medications. This phase entails assessing data that show that the generic product is bioequivalent to the reference listed drug (RLD). Bioequivalence assures that the generic drug is as safe and effective as the innovator product.

  4.Onsite Inspection

Inspection of the Factory Premises of the manufacturing. Regulatory bodies may perform on-site inspections of manufacturing facilities to guarantee compliance with Good Manufacturing Practices (GMP) and the quality and consistency of the manufacturing processes.

  5.Approval Phase 

Approval of the ANDA. When the regulatory authority is satisfied with the technical data, bioequivalence, and manufacturing facilities, it may authorize the ANDA. Approval enables the generic medicine to be promoted and sold as an alternative to the reference listed drug.

Documents

1.  Free Sale Certification

2. Certificate Of pharmaceutical product

3. Quality Documents

4. Non-Clinical Documents

5. Clinical Documents