on october 29, china food and drug administration issued a notice of relevant issues in respect of new revised gmp certification review and registration transition.
the notice said, to further carry forward implementation of the new revised gmp, china food and drug administration specifically researched into the issues concerning new revised gmp certification review and registration transition which has been frequently reflected and province (autonomous region, direct-controlled municipality) food and drug administration should properly solve production transition of new and old workshops in corporate restructuring process. corporate newly revised gmp medicine certification application can be accepted and certification on-site inspection can be carried out in respect of the newly built workshop of which the drug varieties production address is about to be changed while medicine approval number affiliation is not changed during the modification of new revised gmp. gmp certificate can be issued to those that comply with requirement after the drug varieties registration supplementary application address is changed. drug manufacturing enterprises should ensure the production transition of new and old workshops. the new and old workshops can’t be used at the same time or the product should be traceable.
the notice still requires province (autonomous region, direct-controlled municipality) food and drug administration to ensure the drug registration production site inspection and the transition of new revised gmp certification. during the new medicine and the medicine registration procedure in accordance with new medicine procedure declaration, the enterprise can apply for registration on-site review and apply for new revised gmp certification, as they can be carried out at the same time. the gmp certificate is implemented by the national general bureau and inspected collectively by the national general bureau certification administration center. consolidated inspection should meet the above two inspection requirements. gmp certificate can be issued to those that comply with requirement after drug varieties registration supplementary application address is changed.