Tags
Exception
The clinical investigation of a drug product that is lawfully marketed in Saudi Arabia
is exempt from the requirements of IND regulations
Specific Class of Exception
if all the following apply :1.The study is not intended to support an approval of a new indication or a
significant change in the product labeling.
2. The study is not intended to support a significant change in the advertising for
the product.
3. The investigation does not involve a route of administration or dosage level or
use in a patient population or other factor that significantly increases the risks
(or decreases the acceptability of the risks) associated with the use of the drug
product.
4. The study is conducted in compliance with institutional review board (IRB)
and informed consent regulations.
5. The study is conducted in compliance with promotion and charging for
investigational drugs regulations.
significant change in the product labeling.
2. The study is not intended to support a significant change in the advertising for
the product.
3. The investigation does not involve a route of administration or dosage level or
use in a patient population or other factor that significantly increases the risks
(or decreases the acceptability of the risks) associated with the use of the drug
product.
4. The study is conducted in compliance with institutional review board (IRB)
and informed consent regulations.
5. The study is conducted in compliance with promotion and charging for
investigational drugs regulations.
Regulation
Guidelines for Investigational New Drugs (IND) Requirements