Of course, the adjustment comes as good news to excipient makers that possess solid R&D strength and quality control. Currently, some senior management of excipient makers have been eagerly anticipating the new adjustment, thinking that it will strengthen the excipient inspection by pharmaceutical producers and the auditing responsibility for suppliers. Ultimately, there will be higher appraisal efficiency.
However, to realize associated appraisal for drugs, excipients and packaging materials, perfection and implementation of filing management system is still required. Despite years of consultation on this system, it has yet to be implemented. It is predicted that concrete efforts will come in 2015 for filing management of excipients and packaging material.
Moreover, as stressed by CFDA officials, the cancellation of registration approval of drug packaging materials and excipients does not mean lower technical standard, but the cancellation of only a part of approval process. Furthermore, the drug preparation producers need stronger quality regulating forces and stricter management of excipient and packaging material suppliers, so as to match the new approval mechanism.
