These guidelines are intended to provide recommendations to sponsors on the requirements for approval of multisource (generic) pharmaceutical products in their respective countries. The guidance provides appropriate in vivo and in vitro requirements to assure interchangeability of the
multisource product without compromising the safety, quality and efficacy of the pharmaceutical product.
The national health and drug regulatory authorities should ensure that all pharmaceutical products subject to their control conform to acceptable standards of safety, efficacy and quality, and that all premises and practices employed in the manufacture, storage and distribution of these products comply with good manufacturing practice (GMP) standards so as to ensure the continued conformity of the products with these requirements until they are delivered to the end-user.
All pharmaceutical products, including multisource products, should be used in a country only after approval by the local authority. Regulatory
authorities should require the documentation of a multisource pharmaceutical product to meet the following:
- quality control specifications; and
- pharmaceutical product interchangeability.
Multisource pharmaceutical products need to conform to the same appropriate standards of quality, efficacy and safety as those required of the innovator’s (comparator) product. In addition, reasonable assurance must be provided that the multisource product is therapeutically equivalent and interchangeable with the comparator product. For some classes of product, including – most evidently – parenteral formulations of highly water-soluble compounds,
interchangeability is adequately assured by implementation of GMP and evidence of conformity with relevant pharmacopoeial specifications…