Regulations Exceptions List

Field	Exception	Specific Class of Exception	Regulation	Details
Drugs	(verification and abridged) Applicable for marketing authorization of both Human and Veterinary medicinal products for the following products: • New Products (New Chemical Entity). • Biological Products (excluding biosimilars, blood products, vaccines and advanced therapy medicinal products “for human”).	(excluding biosimilars, blood products, vaccines and advanced therapy medicinal products “for human”).	Registration According to Verification and Abridged	Details
Drugs	In case of Generic Products: In preparing the dossier for generic products, it is acknowledged that certain modules or sections of the CTD would generally not be applicable and should be marked as such (and not to be deleted). The data requirements for each application will differ, depending on the drug submission type Module 4: Non-Clinical Study Reports Generally not applicable for generic products, however some exceptions may apply.	generic products	The GCC Data Requirements for Human Drugs Submission	Details
Drugs	For products which their manufacturing sites are not registered at SFDA, does SFDA approve the product without site inspection? If the product manufacturing site is located in one of the countries mentioned in the Eligibility Criteria section, site inspection will not be a barrier for the product registration. SFDA will take the necessary actions to maintain the registration within the timeframe.	products which their manufacturing sites are not registered at SFDA ELIGIBILITY CRITERIA • The application must be submitted to the SFDA within two years from the date of approval by the reference agency. • The product does not need a more stringent assessment as a result of different local disease patterns and/or medical practices. • The product and its intended use (indications, dosage information, and patient groups (for human product) or target animal species (for veterinary product)) has not been rejected, withdrawn, suspended by any drug regulatory agency for safety or efficacy reasons. • The manufacturer should be located in one of the following countries: USA, UK, Canada, Australia, Japan, Switzerland, Germany, France, Ireland, Italy, Spain, Portugal, Finland, Sweden, Norway, Denmark, Belgium, Netherlands, Austria or Singapore. The level of manufacturing activity represents: o For Biologicals: Biological Substance and Finished product. o For Pharmaceuticals: Finished Product (bulk) and Primary Packaging.	Registration According to Verification and Abridged	Details
Drugs	The clinical investigation of a drug product that is lawfully marketed in Saudi Arabia is exempt from the requirements of IND regulations	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.	Guidelines for Investigational New Drugs (IND) Requirements	Details