Medical network - April 18 drugadministration law will be further tightened. Key management object is fake medicines and medicines of inferior quality. 

 

The past week, medicine is the most heavily regulated in shandong province. A food drug administration of shandong province on April 10 days revealed 16 drug-handling enterprise violation notice, shall revoke the GSP certification. Then, on April 11, ushered in the people's congress (NPC) check: member of the political bureau of the CPC central committee, vice chairman of the NPC standing committee li jianguo rate inspection group in shandong province to carry out the pharmaceutical administration law enforcement inspection. 

 

First stop: shandong pharmaceutical administration law enforcement inspection 

 

, according to xinhua news agency on April 15, to give the people the good drug quality and JiaGeGuan, strengthen the consciousness of drug safety rule of law and law applied, the eleventh central committee, National People's Congress standing committee of the inspection team came to the first stop in shandong province, from April 11, five days of the inspection work. 

 

Li jianguo stressed during inspection, in drug management, people reflect strong is fake medicines and medicines of inferior quality and drug prices artificially high. To solve the problem of the three aspects, the provisions of the pharmaceutical administration law of targeted. Continuous improvement over the years, but the problem is often appear, still hasn't been cut off, the important reason is that some drug manufacturers and distribution units impotence, law enforcement is lax, refrain from punishing law-breakers government and its departments. 

 

He also pointed out that to solve problems in the field of medicine management, fundamental lies in the realization of drug administration under the rule of law. For violation behavior under the zero tolerance, quickly, punch, constantly improve the level of drug safety, strengthening people's medication security. 

 

Inspection group and drug regulation, generics consistency evaluation problem in-depth understanding, and jinan, zibo city, two pharmaceutical producing enterprises, wholesale, retail enterprises and medical institutions to research, around the implementation of the pharmaceutical administration law of the existing problems and listen to opinions and Suggestions. 

 

Notice: in the province one day 16 drug firms violations 

 

According to eat the food and drug administration's official website of shandong province, on April 10, the total reported 16 pharmaceutical trading enterprises. Linyi city by the source hall large pharmacy chain co., LTD., huang ting chains such as 14 pharmaceutical retail enterprise, rizhao blessings pharmaceutical co., LTD. And other two pharmaceutical retail enterprise, in violation of relevant provisions of the "drug-handling quality management norms", no longer meet the certification standards. 

 

Basis "the drugs management quality management standard certification measures for the administration of the pharmaceutical medical instrument flight check method" the drugs management measures for the management of the quality control standard for certification of shandong province (trial) ", ShengJu revoke the GSP certification in accordance with the law. Law enforcement officials have informed enterprise, should immediately stop drug business activities in accordance with the regulations. 

 

There are big action: outside the province of hubei 

 

On April 12, eat food and drug administration in hubei province, according to the announcement of hubei hong Lin pharmaceutical co., LTD., is from illegally purchases drugs, counterfeit drugs, not according to stipulations in supplying unit sales staff for identity verification, retained materials such as serious violation of the drug supply quality management norms ". Hubei province food drug administration in accordance with law, revocation of hubei hong Lin pharmaceutical co., LTD. "drug-handling quality management standard certificate". 

 

Then, on April 14, the province's food drug administration issued the hubei pharmaceutical quality random inspection specifications (trial) "notice, to drug production, management, use the link for sampling inspection. Notice the first explicitly pointed out that, in the general specification drug quality random inspection work, strengthen the administration of the drug to sample and ensure the public is safe and effective. 

 

Were found among them, the supervision and inspection, sampling process of the following circumstances, not sampling, by the local drug regulatory agency of compulsory administrative measures to seal up, distrain, etc, in accordance with the processing: 

 

(a) the pharmaceutical supervisory and administrative department under the state council regulations banning the use of; 

 

(2) in accordance with the pharmaceutical administration law must be approved and unapproved production, preparation, management, import, or in accordance with the pharmaceutical administration law must be tested and untested namely sales, use; 

 

(3) to use in accordance with the pharmaceutical administration law must obtain approval for the manufacture of active pharmaceutical ingredients and has not obtained the approval number. 

 

(4) the indications or functions indicated are beyond the prescribed scope; 

 

(5) validity not indicated or is altered; 

 

(6) not specified or change the production batch number; 

 

(7) over the period of validity; 

 

(eight) direct contact with drugs packaging materials and containers without approval; 

 

(9) to add colorants, preservatives, spices, taste masking agent and accessories; 

 

(10) production, preparation of drug use accessories medicine fails to meet the prescribed standards; 

 

(11) under the current legal quality standard or not in accordance with the approval of the production process of production without authorization; Not according to the approved standard preparation without authorization; 

 

(12) is entrusted or receive processing without permission; 

 

(13) beyond the scope of production, preparation and trade of pharmaceuticals; 

 

(14) without production or batch records, wholesale business no purchase or sales record, retail business no purchase record; 

 

(15) quality inspection unqualified still sell or use; 

 

(16) no corresponding drug manufacturing facilities or drug inspection equipment, can't ensure the quality of medicines; 

 

(17) pharmaceutical trading enterprises and use the unit sourcing from illegal channels to purchase drugs or no legal documents; 

 

(18) site management confusion, serious environmental does not conform to the hygiene requirements, illegal phenomenon is serious, can not ensure the quality of medicines. 

 

Careful readers will find that the above inspection work, all mentioned "" medicine management, drug safety" people "and other words, team and the National People's Congress standing committee, has been clear about the key management object: inferior drugs and fake! This view, drug management will be further intensified. 

 

Pharmaceutical administration law enforcement inspection first stop is shandong, next stop is? The country!