SFDA’s Product Specific Bioequivalence Guidance

To further facilitate generic pharmaceutical product availability and to support the generic pharmaceutical industry with identifying the most appropriate methodology for designing the bioequivalence/ in-vitro studies, SFDA publishes product-specific guidance describing the Authority's current thinking and expectations on how to develop bioequivalence/ in-vitro studies for the generic pharmaceutical product.

​Disclaimer: This guidance helps applicants meet the expectations of regulators. This guidance should not be understood as being legally enforceable. The applicant can use another approach if the approach satisfies the requirements of the GCC guideline of bioequivalence.​

Bioequivalence:

The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.

Generic pharmaceutical product:

Is a medication developed to be the same as Reference product in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

Reference products:

Pharmaceutical product with which the new product is intended to be interchangeable in clinical practice. The reference product would normally be the innovator product for which efficacy, safety and quality have been established.

Selection of reference products:

Reference Products must be the original brand-name (i.e. manufactured in the country of origin of the original brand name); if this is not available in the local market then the brand-name regarding the same company but different country of origin is used, marketed in GCC region, ICH region, or in any stringent regulatory authority. If the original brand-name is not available in the market or no longer produced, then the product which is the local market leader may be used as a reference product.

Pharmaceutical equivalence:

Medicinal products are pharmaceutically equivalent if they contain the same amount of the same active substance(s) in the same dosage forms that meet the same or comparable standards. Pharmaceutical equivalence does not necessarily imply bioequivalence as differences in the excipients and/or the manufacturing process can lead to faster or slower dissolution and/or absorption.

Pharmaceutical alternatives:

Pharmaceutical alternatives are medicinal products with different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active moiety, or which differ in dosage form or strength.  ​

​Kindly Review The Guidance​ .​​