المملكة: Exemption from oral medications "Bioequivalence"…and restrictions on sensitive treatments

Introduced The Food and Drug Authority A new regulatory draft specifies the criteria for excluding some oral medications from clinical bioequivalence studies. The regulation aims to facilitate drug evaluation while ensuring effectiveness and safety for patients.

The Food and Drug Authority explained that the evidence based on the biopharmaceutical classification system provides a reliable alternative to evaluate the efficiency of drug products in vivo.

It indicated that this procedure reduces the need to conduct clinical bioequivalence studies by relying on accurate laboratory data To justify this exception.

The draft, which was approved by its administration in April of this year, revealed that the exceptions are limited exclusively to solid oral pharmaceutical products and rapid-release suspensions that are designed to reach the circulatory system.

The authority warned that Medicines with a narrow therapeutic index, or those that are absorbed orally and under the tongue, are completely excluded from this regulatory easing.

The regulatory guide stated that the approved classification system divides medicinal substances into four main categories based on the characteristics of aqueous solubility and intestinal permeability.

He pointed out that the exceptions mainly apply to medicines that contain active substances belonging to the first and third categories, which are characterized by high solubility with high or low permeability. respectively.

The authority confirmed that obtaining this exception requires that the active substance be identical between the drug to be tested and the reference drug.

It added that accepting the exception for drugs that contain different salts is conditional on their belonging to the first category Those with high solubility and permeability exclusively.

The document stressed the need for the inactive components in the drug to be tested to be ideally compatible with its reference counterpart.

It called on manufacturers to provide precise scientific and methodological justifications proving that any differences in these components will not affect the rate or extent of absorption of the drug.

With regard to laboratory evaluation, the Authority imposed comparative dissolution tests using a production batch that represents the proposed commercial manufacturing process.

/>It stipulated that the size of this batch should not be less than one hundred thousand units, or a tenth of the actual production size, to ensure the accuracy and reliability of the results.

The new instructions obligated applicants to provide comprehensive information about the basic features of the drug, and detailed reports for all tests and analytical methods used.

This step comes based on the harmonized guidelines issued by the International Council for Harmonization of Technical Requirements for Drugs, to replace previous versions and keep pace with advanced global standards.