CFDA Food and Drug Audit and Inspection Center organized the "Regulations on the Management of Drugs" (Solicitation Draft)，Public opinion of public opinion before the end of this month。This measure should be said to the expectations of most people in the industry，"Draft of Opinions" is suitable for the entire life cycle of the drug，Covering development、Production、Circulation and other activities，Including the clinical trial of the above -mentioned activities、CRO、CMO、commissioned inspection and other units and individuals。For the solution of drug research and development、Production and business areas and GLP、GMP、GSP and other specifications for long -term uncoordinated factors can be described as a good medicine，Just go to implementation，It also needs to be the "Draft" and GLP、GMP、GSP and other specifications to achieve seamless connection，and continue to improve stake betting appthe above -mentioned standardized certification methods。Related R & D、Production and commercial enterprises should be based on the original quality management system，Add special requirements and content of drug management specifications，The workload is also not small。

 

  Sort the five key points

 

  "Draft of Opinions" Chapter 54，Except two chapters of the general rules and appendix，Better quality management、Personnel、Data Management、The four parts of the system stipulate the data management specifications of drugs from research and development to the entire business process。I combed the following key points:

 

  1.，It is clear that the purpose of drafting the "Draft of Opinions" is to regulate the management of related data in the life cycle of the drug，Ensure that the quality of the drug and the patient's medication is safe and effective & rdquo; & ldquo;、Production、Circulation and other activities，Including the clinical trial of the above -mentioned activities、Contract Studies (CRO)、Entrusted production (CMO)、commissioned inspection and other units and individuals & rdquo;，It is horizontal to the edge、Full coverage of the bottom type。The principle of data management is true、Accurate、Timely、traceable，Ensure that data reliability and integrity。

 

  2. Quality management  Clarified & ldquo; Data management as part of the drug quality management system & rdquo;，Putting the concept of & ldquo; quality culture & rdquo; concept，The core of the long -term problem of the pharmaceutical industry，Clear quality risk management is an important tool and technical means for data management。

 

  3. Personnel  This part clarifies the high -level enterprise、Data management responsibility for management and all employees。

 

  4. Data management  Clarified & ldquo; The concept of data life cycle & rdquo;stake online sports betting、Signature unique requirements、Electronic signatures and paper signatures have the same effectiveness requirements、Data Management permissions、Data synchronization record、Refugeous Record。

 

  5. System  "Draft of Opinions" emphasizes & ldquo; When the data is saved in two ways: paper and electronics，Electronic data is the original data。Printing of dynamic data cannot replace its electronic original data & rdquo; emphasizes & ldquo; data process & rdquo; concept，Clarifying the data process design should consider every step of the data process，Make sure and enhance control，Make sure that each step is consistent、Objective and independent and reliable、Simple and simplified、Clear definition and fully understanding、Automated、Scientific and statistical reasonable、Records in accordance with good file specifications，This provision almost avoids all the vulnerabilities of data formed。In this part，"Draft of Opinions" for data verification、Data security、System replacement、Disaster recovery has made clear stipulations。

 

  Once the "Draft of Opinions" landed，GLP、GMP、GSP and other specifications will be more powerful，Pass clear signals to the entire pharmaceutical industry and industry -related fields，It reflects the strong will of the country's standardized development of the pharmaceutical industry。It is conducive to the overall requirements of the four most stricter & rdquo;，Standardize policy、Process and longitude，and can reflect the main spirit of the "Guide to Data and Record Management Standards" previously released by WHO，and confidence in the gradual integration of the Chinese pharmaceutical industry with the world level。

 

  stake online sports bettingDo a good job of standardized articles

 

  If GLP is implemented、GMP、GSP and other physical specifications are the breakthroughs of the Chinese pharmaceutical industry entering the modern civilization of pharmaceuticals，So，The formal implementation of the "Draft of Opinions" will be the key interface to complete the metaphysics of the world's medicine。To do this big article，Suggestion "Draft of Opinions" can consider more industrial expectations。

 

  First，Adopt quality management、Personnel、Data management and system four parts as the main body of the "Draft of Opinions"，There are some overlapping content，There may be difficulties in execution and specific operations，If it is collected by data、Storage、Treatment、Analysis、Audit、Report、Transfer、Backup and/or Archive Save、Search、Verification、Disaster recovery and other order settings，or more conducive to execution。

 

  Second，The principle of "Draft of Opinions"、Main content and processes integrate into GLP、GMP、GSP and other physical specifications，or can strengthen the execution strength and gold content of the above -mentioned physical specifications。or in the main content、Appendix further clarifies the "Draft of Opinions" and GLP、GMP、GSP and other physical specifications to connect methods。

 

  Third，Responsibilities for middle and senior managers and management，A bit vague in functional direction and positioning，Synchronization with the current physical specifications will be better。

 

  Fourth，In view of the current professional level of pharmaceutical companies、Infrastructure and talent status are very different，Some equipment and facilities of existing pharmaceutical companies are difficult to meet the requirements of the "Draft of Opinions"Stake Sports Betting，and many companies have just completed the new version of GMP certification，It takes a long time to prepare for all the actual content，Suggestion Step in place。

 

  Fifth，"Draft of Opinions" The requirements for the management of pharmaceutical companies are comprehensive and specific，But the content of R & D and commercial enterprises still seems to be less and general，It is recommended to improve it again。