About the Author: Regulatory Editor
In 2014, the SFDA introduced the priority review procedure for human drug registration. The new route enables expedited patient access to medications that treat life-threatening conditions, provide a substantial treatment option, or offset a prolonged drug shortage in the Saudi market. In 2017, the SFDA announced two additional fast-track procedures for drug registration: the SFDA verification and abridged procedures.
Let’s clarify in the post the new priority review procedure.
Table of contents
Eligibility Criteria
The drug application has to fall under one of the following four categories:
Treatment of Serious or Life-Threatening Conditions
ًThe priority review scope in this category only covers a specific definition of serious diseases. In addition, the treatment has to be with particular criteria. Therefore, we can say that not all serious diseases can be considered here, nor all the drugs indicated for them.
Therefore, there are two main conditions to meet in this category: one is related to the definition of “serious disease,” and the other is related to how the drug “treats” it:
Serious Diseases
Accepted serious diseases or conditions are those:
- Associated with morbidity that results in a substantial impact on daily functioning.
- Moreover, morbidity needs to be irreversible and persistent or recurrent.
Hence, the SFDA will not accept a priority review request for drugs that are not affecting daily functioning or with morbidity that is self-limiting or short-lived.
If your drug addresses a disease with such a definition, then you can proceed to confirm the second condition:
Treating a Serious Aspect of The Serious Condition
Simply put, a drug can’t be just “used” in patients with a serious condition to be accepted for a priority review. It must demonstrate efficacy in treating a serious aspect of the serious condition.
To clarify this point, below are a few examples of the serious aspects that should be treated or intended for (as suggested by SFDA):
- Affect a serious manifestation or symptom of the condition.
- Able to improve diagnosis or detection of the condition.
- Able to prevent a serious manifestation.
- Able to prevent a condition with possible serious consequences.
- Able to improve or prevent a serious side effect of therapy of a condition.
- Able to treat a condition while avoiding known serious side effects of current treatment, providing that:
- Current therapy is commonly used despite the unavoidable side effects.
- Side effects are a significant public health issue.
- New therapy reflects a significant potential to improve the overall safety profile with at least similar efficacy.
The Drug Addresses an Unmet Medical Need
Under this category, the SFDA will assess the application eligibility in two aspects:
- The drug is developed to address an unmet medical need.
- It demonstrated potential through clinical trials.
Here is more clarification on these two evaluation aspects:
Is it an “unmet” medical need?
Unmet medical needs are those that are not adequately addressed by existing therapy. For example, if no therapy is available for a severe condition, it is an unmet medical need.
On the other hand, if a therapy already exists for the condition, it yet could be considered a case of an unmet medical need if it evaluated one of the following:
- Improved effect(s) on serious outcomes of the condition that are affected by alternate therapies
- Effect(s) on severe outcomes of the condition not known to be affected by the alternatives.
- Ability to provide benefit(s) in patients who cannot tolerate or are unresponsive to alternatives or an ability to be used effectively in combination with other critical agents that cannot be combined with available therapy.
- Ability to provide benefit(s) similar to those of alternatives while avoiding severe toxicity present in existing therapies or avoiding less serious toxicity that is common and causes discontinuation of treatment of severe disease.
- Ability to provide benefit(s) similar to alternatives but with improvements in some factors, such as compliance or convenience, that lead to improved effects on serious outcomes.
Does the drug demonstrate potential?
The SFDA will evaluate the drug’s potential using the provided clinical data or its summaries to determine if it reflects the potential to address an unmet medical need. Note that drug development should be designed to measure this potential.
The first Generic or Biosimilar
SFDA admits the first generic or biosimilar applications into the priority review route to expedite the introduction of alternative options in the market.
Shortage Item
To enhance drug availability, SFDA will consider the priority review for the following candidates:
- The drug is listed in SFDA’s incentive list (shortage list, single-sourced, or not localised).
- Drugs are available in any essential drug list, such as the Local Content Authority list and the Government Procurement Authority.
Timelines
Priority registration offers a 40% reduction in regular registration timelines. They are as follows:
- Human Generic: 93 working days.
- Human New Drugs registered in SRA: 168 working days.
- Human New Drugs not registered in SRA: 243 working days.
- Human Biologics registered in SRA: 168 working days.
- Human Biologics not registered in SRA: 243 working days.
- Radiopharmaceuticals: 168 working days.
SRA: Stringent Regulatory Authority.
Note that good preparation of the priority review request would increase the probability of acceptance. We have seen eligible cases turned down by the SFDA due to a lack of proper elaboration and presentation.
Fees
The applicable fees are the same as the regular SFDA Registration Fees.
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