October 18，CFDA posted on its official website & ldquo; publicly solicited three appetis of the "Drug Operation Quality Management Specifications" internal review and management & rdquo;。Its pointed out，In order to do a good job of new revision of the "Specifications for the Management of Drug Management" (hereinafter referred to as & ldquo; gsp & rdquo;) implementation work，CFDA is drafted "Internal Trial Management"、"Pharmaceutical Retail Chain Management" and "Drug Retail Pharmaceutical Service Specification Management" 3 appendix。The three appenders this time are drafts for comments，Soliciting time as of November 18, 2016，The province (district、City) Food and Drug Administration and Xinjiang Production and Construction Corps & RDQUO;。

 

  "Internal Trial Management" Appendix is ​​mainly drug business enterprises according to the requirements of GSP，Organize the review of key elements and operating status of the enterprise quality management system、Evaluation、Improvement and other activities，Guarantee system continues to operate effectively。Actually，In short，It is to start a self -check for drug business enterprises，According to & ldquo; internal review & rdquo; requirements，Enterprises should organize a comprehensive internal trial every year。

 

  CFDA releases the new version of GSP，This time I introduced three attachments，As a supplement to GSP，From the perspective of its overall，It is mainly strengthening the management of drug retail，This is the first time in the previous modification of GSP several times。For My stake betting appthe Stake Sports Bettingretail chain of drugs，The relevant provisions of the "Related Regulations on the Retail Chain Enterprise of Drugs" introduced in 2000，And this time the "Pharmaceutical Retail Chain Management" solicited comments draft，It is a more detailed management of pharmaceutical retail companies，"Drug Retail Pharmaceutical Service Specification Management" will conduct targeted sexual management。

 

  From the introduction of three appendix policies，Display three information，First，Field of Pharmaceutical Industry、After self -examination in the business field，Similar management in the field of pharmaceutical retail，and become a conventional action，Examnarian review every year; second，Electronic supervision code exit the historical stage，Establish & ldquo; computer system & rdquo; realization traceability through pharmaceutical retail chain companies; third，& ldquo; Pharmaceutical service & rdquo; It has always been a weak link for Chinese drug retail，This is a targeted improvement，It may be a way for & ldquo; Powering & rdquo;。

 

  1 is the new trick tracing it?

 

  Since the new version of GSP is based on the "Pharmaceutical Retail Chain Management" (hereinafter referred to as "Management")，Must be unified leadership of the corporate headquarters required by GSP，Establishing coverage includes the management departments of the headquarters、Enterprise logistics distribution agency and the quality management system of all chain stores，Implement a unified enterprise logo、Unified Management System、Unified computer system、Training of unified personnel、Unified purchase and delivery、Unified Bill Management、Unified Pharmaceutical Service Standard，Realization of scale、Group management and operation, etc.，Requires enterprises to further standardize、Clear responsibility、permissions and mutual relationships，Formulate the quality management system document。

 

  Of course，Increase the quality of drug retail chain management，First of all, you have to start with the personnel，So the "Management" requirement，Drug retail chain Enterprise Headquarters shall formulate an annual training plan for the enterprise，Unified training content，Training work in accordance with regulations。

 

  Actually，For management，"Management" is more starting with the hardware system，Enhanced computer system，Reduce human operation。Its pointed out，The computer system established by the headquarters shall stake betting appStake Sports Bettingbe able to implement a unified management of the headquarters and stores，On the basis of GSP，Requirement system should realize information transmission between headquarters and stores、Data sharing、Bill management and other functions，Data should be two -way、Real -time、Automatic transmission; System does not support stores to purchase、The store relieves the quality control and drug lock instructions、Store information display and business exchanges。

 

  In addition，Article 6 of the Management，The headquarters quality management department is responsible for the review of computer system operation permissions、Control and Quality Management Basic Database Establishment、Maintenance and update，Not only compliance with GSP requirements，It should also include a store store、Store acceptance staff、Store business scope and variety; the basic data of quality management and the legality of the corresponding stores and distribution pharmacies、Effective association，Correspondence with the business scope and variety of stores，Tracking from the system、​​Identification and control。

 

  Overall，The requirements for the retail chain of the drug are that the computer must be realized，A company，A set of system，All information of all pharmaceutical products trace back，instead of involving human situation。Headquarters is responsible for product procurement，Stores must not purchase，So here，A product enters a retail chain，Easy to link the computer system，Flowing afterwards、Persons can be obtained very clearly。"Management" requirements are，The store is approved by the headquarters，Do not adjust the medicine by yourself，The store reports to the headquarters to the headquarters to submit the name of the drug to the headquarters、Specification、Dosage form、batch number、Validity period、Production enterprises and the number of adjustments，Delivers，The headquarters shall apply according to the store's drug adjustment，Postering the recovery and delivery document of the regulating drug through the computer system，Develop special personnel responsible for the recovery and distribution of drugs。For sales，Retail Chain Headquarters is a unified store sales voucher style，When the store sells drugs，Should automatically generate a sales bill of the famous store name through the computer system。

 

  July new version of GSP stake sports betting appstake online sports bettingintroduced，Electronic regulatory code exit the historical stage。But the State Administration still requires urgency for the traceability management of drug circulation，Now "Management" to strengthen the circulation of drugs in retail chain through the computer system to achieve supervision。It emphasizes drugs & ldquo; computer system & rdquo; docking，Reduced artificial records at the maximum limit，Let the retail chain company's subject & mdash; & mdash; headquarters responsible，Through the computer system, traceable，Finally achieved regulatory purpose。

 

  2 is the prescription outflow & rdquo; pave the way

 

  Long -term，Chinese pharmacies are more of the role of hypermarkets，& ldquo; Pharmaceutical service & rdquo;，The number of practicing pharmacists is small，But the number of pharmacies is large，and it does not match，But the pharmacy is still developing prosperous。

 

  And the "Specification of Drug Retail Pharmaceutical Service" (hereinafter referred to as & ldquo; "Specifications" & rdquo;) directly point out & ldquo; pharmaceutical service & rdquo;，Pharmaceutical service & rdquo; ability。Requirements in GSP before，Enterprises shall provide customers with medication consultation、Prescription review、Preparation、Checking、Drug guidance、Disassembly of the medicine、Collect of Pharmaceutical Adverse Reactions、Tracking follow -up and other pharmacy services，Provide security to customers、Effective、Economy、Reasonable medicine。

 

  This "Specification"，Not only for & ldquo; pharmaceutical service & rdquo; hardware venue、The facilities posted on the request，For example, via a special phone、Internet and other methods to provide customers with medication consultation、Pharmacy services such as after -sales complaints，And the person in charge of the enterprise is the main person in charge of the quality of pharmaceutical services，It should be responsible for providing the necessary conditions for pharmacy service personnel，Guarantee pharmacy service personnel effectively perform their duties。There are also ethical requirements for pharmaceutical service staff，Must follow unscientific propaganda、false publicity、Exaggerated publicity，Deception misleading customers。

 

  In addition，This focus has also made specific regulations on sales prescription medicines。Regulations Article 12:，When the prescription of the sales prescription，Stake Sports BettingStake Sports BettingProfessional pharmacists shall be responsible for prescription review，Drugs listed on the prescription shall not change or use it without authorization，Prescription with compatible taboos or overdose，It should be rejected，But the prescription doctor changed or signed the confirmation，can be prepared。After the preparation prescription，Pharmaceutical service personnel shall compare the prescription，Name of name、Product regulations and customer names、Gender、Age and other information。

 

  Actually，In addition to the above -mentioned person & rdquo;，This "Regulations" made a series of specific regulations on drugs other than OTC，Its purpose is to get closer to & rdquo;，Through detailed rules，Let the pharmacy truly bear the guidance of consumers。This is also linked to the major policy & rdquo;。

 

  Although since the new medical reform，The country encourages medical institutions & ldquo; prescription outflow & rdquo;，But the integration industry believes that implementation difficulties，Reasons for the reason，Pharmaceutical retail chain institutions cannot bear the risk brought by prescription & rdquo;，Now clearly clarified the responsible person of the retail chain and the retail chain & ldquo; pharmaceutical service & rdquo;，Intent to make risks controllable，Overall improvement of pharmacist service quality，Playing the way，For & ldquo; Prescription outflow & rdquo; Play the foundation。