The State Food and Drug Administration today released the "Relevant Regulations on Strengthening the Supervision and Management of Medical Accessories (Draft for Opinions)" (hereinafter referred to as "Draft for Solicitation of Opinions")，Public comments from the society。"Draft for Consultation" clearly proposed，Drug preparation manufacturers are the responsible person of My stake betting appthe quality of drugs，Pharmaceutical preparation manufacturers must strictly check the accessories used by drug production，and audit the supplier。
 
Pharmaceuticals refers to the gymma and additional agent used in the production of drugs and preparation prescriptions。Medicinal Accessories is an important part of the medicine，can directly affect the quality and safety of the medicine。To further strengthen the production of medicinal accessories、Supervision used，Ensure the quality and safety of the medicine，National Food and Drug Administration in accordance with relevant regulations，Formulated "Draft for Solicitation Opinions"。
 
According to the "Draft for Soliciting Opinions"，The National Food and Drug Administration will take the following measures，Further strictly strictly strictly produced and used management。First, by further implementing the responsibility of drug production enterprises，Promote its conscious performance of auditing and management of pharmaceutical auxiliary materials production enterprises and their products; the second is to further implement the responsibility of the regulatory department，Realize extension supervision of pharmaceutical auxiliary materials production enterprises; the third is to implement stake betting appGMP、Carry out classified management and associated review with drug preparations，to improve the barriers to access to medicinal auxiliary materials; fourth, by increasing the strike strength，Shock violations and regulations，Guide drug preparation manufacturers and pharmaceutical accessories production enterprises standardize production and use。
 
"Draft for Consultation" clearly proposed，Drug preparation manufacturers are the responsible person of My stake betting appthe quality of drugs，Pharmaceutical preparation manufacturers must strictly check the accessories used by drug production，and audit the supplier。The medicinal auxiliary materials purchased must be used for the production of drugs after passing the standard inspection。"Draft for Consultation" emphasized，Drug preparation manufacturers must produce drugs in accordance with the prescribed prescription process，Research should be carried out in accordance with relevant regulations if changes，Perform the change procedures。
 
"Draft for Solicitation of Opinions" clarifies the supervision responsibilities of the pharmaceutical regulatory authorities at all levels and pharmaceutical auxiliary materials production enterprises，Require drug supervision departments at all levels to take drug production enterprises as the supervision My stake betting appfocus，At the same time, you can follow the test results of the drug preparation manufacturer，Extension inspection of the auxiliary materials manufacturer，Production of medicinal accessories、Usage is included in the regulatory vision，A full supervision of the pharmaceutical production supply chain was realized。
 
"Draft for Consultation" Manage the medicinal auxiliary materials with reference to the raw medicine，Increasing supervision: First, it is required to organize production in accordance with the requirements of the "Management of Medical Accessories Production Quality Management"，Improve the threshold for the entry of manufacturers; the second is to implement classification management of the auxiliary materials based on the degree of risk，Practice a strict access system for high -risk auxiliary materials and manufacturers，Strengthen risk control; third, requiring new medicinal accessories must be associated with the drug preparation，Emphasize the check and auditing responsibility of drug production enterprises for new accessories，Further strictly strictly strictly strictly fixed sources and technical requirements for drugs used for drugs; the fourth is to improve and improve the standard of medicinal accessories as the current work focus，It is beneficial to the further improvement of My stake betting appthe quality of the drug preparation。
 
The deadline for this solicitation is June 8, 2012。