Drug Treatment Program Specifically Requests Registration of Production and Circulation Areas – Drugs, FDA, Medical – Pharmaceutical Industry

Drug Treatment program specifically requests registration of production and circulation areas – drugs, FDA, Medical – Pharmaceutical Industry

In order to fully implement the National Quality Work Conference, the State Council’s product quality and food safety requirements of the Office of the Leading Group, under the “national product quality and food safety special rectification program of action,” the content, by the State Food and Drug Administration in conjunction with the lead Development and Reform Commission, Ministry of Public Security, Ministry of Health, Customs, SAIC, AQSIQ ministries to develop product quality and food safety, the State Department Office of Drug Regulation Group leading the work of implementation.

Drug Regulation Implementation Plan identified group organization, the main duties of the river and mission objectives and implementation steps.

Implementation plan tasks and objectives of drug regulation made clear requirements.

One part of drug registration Tasks: to continue the unified arrangements of the State Council, on January 1, 2005 to August 2006 has received 31 new drugs not yet approved by management and existing national standards for drug registration, and in January 2006 1 to August 31 the period approved for production of the species to carry out on-site verification; to landmark l GB uniform renewal drug approval number of the species as the focus, as at August 31, 2006 has issued a drug approval number for inventory, approval number to confirm the authenticity of; combination drug approval number inventory, to landmark l GB, beyond the scope of the production permit and safety of high risk species as the focus, strict control, steadily carrying out re-registration (Food and Drug Administration is responsible).

Objectives: for registration verification completed by the end of this year, so that the phenomenon of drug registration fraud claims data are checked, to significantly improve pharmaceutical research; to establish a complete and accurate database, complete control of a drug approval number has been listed on the general situation, clear suspected fraud in the drug approval number; through the drug approval number inventory and re-registration, effectively eliminated do not have the production conditions, quality can not guarantee greater security risk products, perfect and improve the drug registration system.

Second, pharmaceutical production areas Tasks: to carry out injection class of drug production and prescription verification process, urging pharmaceutical companies in strict accordance with the approved production process, prescription organization of production; further strengthen the pharmaceutical production and quality control, and gradually expand to the presence of high-risk varieties manufacturer supervisors; strengthen the implementation of GMP pharmaceutical manufacturing enterprises to track inspection work, the company reported a mass flight inspection, and urge enterprises to consciously strictly implement the “Good Manufacturing Practices” (GMP); to achieve the first of narcotic drugs and psychotropic drug sales flow real-time monitoring. (Food and Drug Administration is responsible)

Objectives: the end of this year to complete the large volume injection class of drug production and prescription verification process, the deployment of the large volume injection type species and the special focus on monitoring a comprehensive presence of monitors drug manufacturers to amend the “Drug GMP certification examination assessment standards “throughout the country to achieve the first class of narcotic drugs and psychotropic drugs, and small packaging bulk drugs production, purchase, sales, inventory quantities and flows of real-time monitoring.

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