It is important for regulatory agencies to implement priority review processes in order to expedite drug approval processes. This ensures fast access to safe innovative treatments and life-saving medicines. By streamlining drug review processes that address unmet medical needs, or offer better treatment options compared to existing therapies, these processes can accelerate patient access. This would ensure that critical therapies reach those who need it and also enhances the healthcare system- ultimately enhancing patient and public health.
In 2014, the Saudi Food and Drug Authority (SFDA) implemented a priority review process for the registration of drugs. This expedited pathway is designed to ensure quicker patient access to medications that address life-threatening diseases, offer significant therapeutic benefits, or help alleviate prolonged drug shortages in the Saudi market. The priority review designation indicates that the review process of the application will be expedited by the concerned departments. However, this designation does not alter the scientific standards and quality of evidence required for approval.
By 2017, the SFDA introduced two more accelerated drug registration processes: the SFDA Verification Procedure and the SFDA Abridged Procedure.
Criteria for Qualifying for Priority Review Designation
New Drug & Biologicals
The priority review process for new and biological drugs is intended for the treatment of serious or life-threatening conditions and/or demonstrates the potential to address unmet medical needs.
Serious or Life-Threatening Condition
For a product to be eligible for priority review, it must be intended to treat a serious aspect of a serious condition. The SFDA will evaluate if the priority review program aims to demonstrate an impact on a serious aspect of the condition. Examples include:
- A therapeutic product evaluated for effects on serious manifestations or symptoms of a condition.
- A drug evaluated for its impact on a serious aspect of a condition or its ability to improve diagnosis or detection, which could lead to improved outcomes.
- A preventive product evaluated for its ability to prevent serious manifestations of a condition or the condition itself, assuming prevention leads to avoiding serious consequences.
- A product deliberated to improve or prevent serious side effects of therapy for a condition.
The SFDA might classify such therapy as a priority review drug development program when:
- The Currently accepted therapy is used widely despite unavoidable serious risks.
- Serious outcomes are important public health issues.
- The new therapy shows significant potential to have a substantially improved overall safety profile with at least similar efficacy.
Demonstrating the Potential to Address Unmet Medical Needs
An unmet medical need is a medical need not adequately addressed by existing therapies. For conditions with no available therapy, there is an obvious unmet medical need. For conditions with available therapies, the new drug would address unmet medical needs if it:
- Improves effects on serious outcomes affected by alternate therapies.
- Affects serious outcomes not known to be impacted by alternatives.
- Provides benefits in patients unable to tolerate or respond to alternatives.
- Can be used effectively in combination with other critical agents not combinable with existing therapies.
- Avoids serious toxicity present in existing therapies or common toxicity causing discontinuation of treatment.
The type of information required to show the potential of a drug product to address unmet medical needs depends on the stage of drug development. Clinical development data should support the drug’s potential, and the development plan should assess this potential. The SFDA will depend on summaries of available data to determine whether this potential has been demonstrated.
Process for Designating a Drug for Priority Review
A. For New Generic & Biological Drug (Human or Veterinary)
- A Request for priority review is sent to the Drug sector before submission.
- The Drug sector responds to the applicant within 15 working days.
- Upon request approval, the decision is sent via SDR’s email (SDR.Drug@sfda.gov.sa).
- The approval email is attached to the cover letter in module 1.
- The drug file is submitted.
- Priority review begins.
B. For Biosimilar Drug
- Priority review of biosimilars is requested on the eSDR application.
- Submission of the drug file.
- Upon request approval, the application will be shown on the High Priority Tab.
- Priority review begins.
Timeline
The review clock will not begin until the product has been accepted for priority review. The total performance target is reduced by 40% of the normal registration process as described in the “Regulatory Framework for Drug Approvals.”
Conclusion
The Saudi Food and Drug Authority (SFDA) has established a comprehensive priority review process to expedite the registration of drugs that address critical medical needs. This pathway ensures that patients in Saudi Arabia gain faster access to medications for serious or life-threatening conditions and those offering significant therapeutic benefits.
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