3、Step-by-step delegation of GMP certification power to normalize effective regulation
1-Delegating certification power to inspect defects and facilitate normalized regulatory model
In the “Three-Fix” program formulated by CFDA in the end of March 2013, the first part of “delegated responsibilities” shows a clear sign of policy with the statement that “the responsibility of certifying the quality management standard of drugs and medical appliances shall be delegated to provincial food and drug administrative authorities”. Afterwards, at the opening ceremony of a certification inspection training class held in Hangzhou in May 2013, the official from the certification center of CFDA introduced that the certification power of high-risk products (blood, radiation and sterile products) will be delegated to provincial administrations, which will start from January 1, 2015. After delegation, the certification center of CFDA will be mainly responsible for revising GMP standards, detailed rules, regulations and appendixes, training inspectors and supervising the work of provincial certification centers.
Provincial administrations have all started organizational and technical preparations for the power delegation. For example, Tianjin municipal administration conducted sterilization seminars for GMP inspectors in September 2014, to lay the foundation of undertaking the certification on sterile drugs delegated by the general administration of CFDA.
In respect of China’s current drug management system, the delegation of GMP certification of high-risk products (blood, biological, radiation and sterile products) may lead to stronger regulating efforts, which requires to pharmaceutical companies to continuously improve its quality systems for increasingly frequent inspections.
