drugs and control, defraud the license or drugs and approve proving file, draw the false survey report waiting for the punishment of the illegal activities.

(e ) Drugs of our country have been supervised by the regulation and method with effective management since receiving reform and opening up to the outside world abundantly. Have stipulated drugs authentication system of implementing, drugs classification management system and drugs negative reaction and report system, etc.

(e1 ) Stipulate that implements drugs authentication system. Management for research, production and operating unit of drug need standardization, and promote drugs quality further.

CDRA only ask that drugs manufacturing enterprise must make and carry out and guarantee drugs quality rules and regulations and hygiene demanded. According to experience making and pursuing "Good Manufacturing Practice" (GMP) and "Good Supplying Practice" (GSP) in recent years in our country, CNDRC revised claim: "drugs manufacturing enterprise accords with the regulation of GMP, can be issued the authentication certificate" (The clause 9). "Drugs department supervision and administration manage the enterprise and accord with carry on authentication request on GSP to drugs according to the regulation, Qualified to authentication, issue the authentication certificate " (The clause 16). Have made GMP clear in above-mentioned clause, GSP legal status it is must not have been the strong it promote it is last drugs, the consciousness that the management enterprise raises the quality, and strengthen strict quality control, transfer the focal point of enterprise work. Come on moving and accelerate the technological progress and improve the laborer's quality correct orbit. CNDRA revised add and stipulate even: "Non clinical research institution and clinical research institution must carry out Good Laboratory Practice for Non.Clinical Studies (GLP) and Good Clinical Practice (GCP). (The clause 30)." Carrying on GLP and GCL, will impel drugs to study more strict and cautious, scientific and standard.

The drugs authentication system of CNDRA revised Includes authentication of GMP, GSP, GLP, GCP, etc. Strictly raise drugs production, drugs study and drugs management. And improve drugs quality. In the form of law overcomes to repeated competence from source in low levers. The medicinal causes of our country develop the meaning in a healthy way greatly to promoting.

(e2 ) Stipulate and implements the prescription with classifying management systems in drug. The State Council is about implementing drugs and classifies the determining to bring into the legal track of management.

The prescription drug must be bought according to the doctor's prescription, and drugs used under the guidance of doctor. Only if Over-The-Counter (OTC) drug is after practice patients can buy by oneself long-term and clinically thinks through selecting by the expert, can use and can guarantee drugs of security. To classify managing prescription drugs and OTC drugs is a current drugs management mode in the world. Through strengthening supervision management to prescription drug and OTC drug, Standardizing drugs production, managing the behavior, guide masses' science to use the drug rationally, and reducing drugs excessive use it with emergence of drugs negative reaction. It is safe to be effective to protect masses and use the drug. This is a more important thing.

In January of 1997," determination for reforming the hygiene in the State Council " pointed out: " the country sets up and improve with classifying management systems in drug in prescription". However, current management does not make the regulation to classifying the management system. So, formulation of setting-up of classifying the management system of drugs and every related policy, lack the essential legal foundation. Real constructing drugs has relatively great