The State Food and Drug Administration (SFDA) recently issued a notice to further define time limits for ophthalmic preparations and related products to meet the requirements of newly revised GMP.
In accordance with the notice, intraocular injections, ophthalmic inserts, ophthalmic preparations used in surgery and treatment of wound and penetrating injury of cornea as well as ophthalmic liquid preparations should meet the requirements of the newly revised GMP before December 31, 2013; other ophthalmic preparations should meet the requirements of the newly revised GMP before December 31, 2015; all the other preparations and drug substances which are subject to sterility test items as required in the official drug standards should meet the requirements of the newly revised GMP before December 31, 2013; In vitro diagnostic reagents regulated as drugs should meet the requirements of the newly revised GMP before December 31, 2015.
