In 2014, the SFDA introduced the priority review pathway for human drug registration. The essence of this new route is to expedite the patient access to medications that treat life-threatening conditions, provide a substantial treatment option, or to offset a prolonged drug shortage in the Saudi market.
Table of contents
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 special 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:
Accepted serious diseases or conditions are those:
- Associated with morbidity that results in a substantial impact on daily functioning.
- Moreover, it needs to be irreversible morbidity 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 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. In fact, it must demonstrate efficacy in the treatment of 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):
- Have an effect on 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 in spite of the unavoidable side effects.
- Side effects are a significant public health issue.
- New therapy reflects a significant potential to improve 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 data.
Here is more clarification on these two evaluation aspects:
Is it an “unmet” medical need?
The unmet medical need is the medical need that is not addressed adequately by any existing therapy. If there is absolutely no available therapy for a serious condition, then it is clearly 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 serious outcomes of the condition not known to be affected by the alternatives.
- Ability to provide benefit(s) in patients who are unable to tolerate or are unresponsive to alternative 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 serious toxicity that is present in existing therapies, or avoiding less serious toxicity that is common and causes discontinuation of treatment of a serious disease.
- Ability to provide benefit(s) similar to those of alternatives but with improvements in some factors, such as compliance or convenience, that is shown to lead to improved effects on serious outcomes.
Does the drug demonstrates potential?
The SFDA will evaluate the drug potential using the provided clinical data or its summaries to determine if it reflects the potential to address an unmet medical need. Note that the drug development plan should be designed to measure this potential.
SFDA exempted list
The third category of drugs accepted for priority review is including those in the SFDA exempted list (exempted from paying the registration fees). They are supported by SFDA due to the long term shortage of supply in Saudi Arabia.
First or second Generic
To expedite the introduction of generic drugs, SFDA accepts any first or second generic application into the priority review route.
The priority registration offers a 40% reduction on the 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.
Good preparation of the priority review request would increase the acceptance probability. We have seen eligible cases got turned down by the SFDA due to a lack of proper elaboration and presentation.