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»05/04/2007 [Industry news]
SFDA Newsletter of March

SFDA clarified the explanation of “The Illegal Gains” in Drug Administration Law and Regulations for the implementation of the Drug Administration Law.(16 Feb.2007) SFDA has been trying out sending inspectors to the drug manufacturers.(25 Feb.2007) The State Food and Drug Administration revised the “Warning” and “Notes” contents in the insert sheet of Ceftriaxone Sodium.(26 Feb.2007) The National Development and Reform Commission (NDRC) takes six measures to strengthen the medical price administration (3 Mar. 2007) SFDA solicits opinions on Provisions for Drug Registration(Draft for comment)(12 Mar. 2007) Investigation workshop for the obtaining availability of the essential drugs was held Jinan City of Shandong Province.(12 Mar. 2007)

 
 

SFDA clarified the explanation of “The Illegal Gains” in Drug Administration Law and Regulations for the implementation of the Drug Administration Law
 
Recently, SFDA clarified “the illegal gains” in Drug Administration Law and Regulations for the Implementation of the Drug Administration Law.
 
Under the normal circumstances, “the Illegal Gains” in Drug Administration Law and Regulations for the Implementation of the Drug Administration Law refers to the whole income when implementing the illegal activities.-
 
Under the Article 82 and 87 in Drug Administration Law, “the illegal gains” refers to the fees which are charged in the illegal activities.
 
Under the Article 81 in Regulations for the implementation of the Drug Administration Law, “the illegal gains” refers to the price differences between the purchase prices and sold.
 
During the specific enforcement process, the relevant authorities should be considered by the facts and the evidences of the specific case, and then settle it legally, especially according to the basic principles of administrative punishment.(2007.02.16)
 

SFDA has been trying out sending inspectors to the drug manufacturers
 
To strengthen the supervision and inspection for drug production and further standardize the order of drug production, SFDA issues a Notice that SFDA has been sending inspectors to
the manufacturers for these high risk drugs, like, the injections, the biological products and some special drugs ,according the requirements of “National Teleconference o f Strengthening Supervision on Drugs and Food Stuff” which is held by the State Council.
 
The notice requires that the provincial and municipal drug regulatory departments should send the inspectors to the blood product and vaccine manufacturers before the end of March in 2007. And then, on the basis of summing up the working experience, SFDA will also gradually arrange inspectors to the intravenous injection manufacturers and the special drug manufacturers. These inspectors will be selected from the drug regulatory departments and their affiliated organizations within the administrative area of each province and municipality. The selected inspectors should be honest, upright, familiar with drug laws and regulations, and be full of drug supervision and inspection experience. The name list of the inspectors should be reported to SFDA timely. SFDA will organize the different training programs based on categories of drug for these respective inspectors.
 
The main responsibility of these inspectors is to inspect the GMP compliance situation of drug manufacturers. Key inspection items are as follows: the legal sources of APIs and excipents, the consistency between the production process and the approval process, whether the drug tests according to the standards, the quality assurance measures and etc. As for inspection on some special drugs, these, such as, the production plan, the quantities of purchasing and selling and the storage condition, should be included in the inspection items. The inspectors should regularly submit the inspection reports of product quality and safety to the responsible drug regulatory departments, and timely reported the updated information.
 
The notice also requires the provincial and municipal drug regulatory departments to strengthen the contribution of the organizational structures for these inspectors. And they should report problems, comments and the implementation process to SFDA timely. SFDA will conduct by surveys on these inspectors in different areas, and then, sum up the working experience timely.(2007.02.25) 
 
The State Food and Drug Administration revised the “Warning” and “Notes” contents in the insert sheet of Ceftriaxone Sodium
 
According to the ADE of the simultaneous use of Cerftriaxone Sodium and Calcium-Containing solution, the Centre for Drug Evaluation of State Food and Drug Administration confirmed the result of dead cases that newborns and infants dead because they use the solution. For the safety use of Ceftriaxone Sodium, the State Food and Drug Administration issued a notice
on February 15, 2007 to revise the contents of the “Warning” and “Notes” for Ceftriaxone Sodium in the insert sheet.
 
The “Notice” said that drug manufacturers should revise the insert sheet and labels for their products in compliance with the requirements as early as
possible, and inform the relevant medical institutions and the drug distributors about the revised contents. These relevant drug manufacturers should also actively follow up the
safety situations of the clinical application for the Seftriaxone Sodium, and then, collect and report ADRs according to regulations.(2007.02.26)
 
 
The National Development and Reform Commission (NDRC) takes six measures to strengthen the medical price administration
 
The National Development and Reform Commission declared that six measures would be taken to strengthen the medical price administration in order to remit the issues of high medical expenses for the public.
 
The NDRC will revise the current pricing methods for drugs, adjust the administrative range of drug price, improve the checking and rectifying ways of the drug prices, regulate the governmental pricing procedures, enhance the initiative of public participating in drug price administration and continuously advancing the scientific and transparent administration on medical price of the government.
 
The NDRC will keep on depreciating the drug prices on the high side, extruding the irrational distribution linkages, studying and fixing the category of classic drugs, encouraging
these designated manufactures to produce and supply these low-price drugs, and simplifying the packages and reducing the costs.
 
The third measure is to intensify the research and supervision on drug cost and price. The NDRC will establish a general examination system on the drug cost, launch the special cost
investigation to these crucial categories, establish and improve the price supervision system on the drug market and the crude drug market, and ensure that the competent departments of price are aware of the price changes on both domestic and international market.
 
The fourth is to conduct the necessary intervention on the prices for these high value medical consuming materials. On the basis of the wide surveys and opinions seeking for over one year, the NDRC will continue the intervening measures on the prices for the medical consumption materials. Through strengthening the price investigations and surveillances, the NDRC will also publicize the market price conditions, rationally guide the pricing process for enterprises, and
take the public opinions to regulate the trade and the use of medical consumption materials.
 
The fifth is to enhance the administration on the rural medical price. By cooperating with the promotion of new-type collaborating medical system in the rural areas, the NDRC will enact the administrative measures on the medical price which would be suitable for these consuming features of the rural residents, intensify the bulletin for the rural medical price, improve the transparency of the rural medical price, and earnestly protect the rights of the rural residents.
 
The sixth is to regulate the medical service, improve the price e administration for the medical service, and rationally adjust the medical service price. The NDRC will properly insist on the growth of the medical service price that reflects the value for these health-care professionals, reduce the exam and treatment prices for the large-sized medical equipments, and improve the reimbursement structures for the medical service. (2007.3.3)
 
 
SFDA solicits opinions on Provisions for Drug Registration(Draft for comment)
The existing Provisions for Drug Registration is under modification by the State Food and Drug Administration (SFDA). It now is soliciting opinions on Provisions for Drug Registration (Draft for comment) for two months through the SFDA official website at www.sfda.gov.cn. The new provision will be issued in year of 2007.
 
Reviewers will take the collective responsibilities.
The new Provisions for Drug Registration will clearly establish the “three-dimensional” regulatory approval system for the technical review, the spot check and the sample
testing. The new drug registration will be carrying out under the system of chief umpire in charge, the accountability system and the expert appraisal system. That means, the
review team undertakes the collective responsibility to prevent the abuse of power by individuals; under the accountability system, it is to enhance the responsibility tracing when drug approval against the law; and under the expert appraisal system, it will be noticed that the personnel for the process of the review, the exam and approval, and the proof test, will be
publicly notified, and the process of drug registration will be monitored in public.
 
The new definition of New Drug will be made.
According with the Drug Administration Law of People’s Republic of China and Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, the reversion of Provisions for Drug Registration (draft for comment) will redefine the concepts
of New Drug. These that the market existed drug change to new dosage form, new drug delivery method or new indication and usage cannot apply as the new drug to examine and approve, only can apply under the new drug application process.
 
In the pre-registration of new drug, departments of food and drug administration will do spot check for the development of the new drug, and look through all documents of new drug application to insure the integrality, the standardization and the authenticity.
 
The new drug test will expend the restriction of the scope.
Compared with the current Provisions of Drug Registration, the new provisions will be modified a lot, which is adding the sections of the basic requirements for drug registration and
the examination and approval for application of generic drug, and expurgating the contents o application for drug registration, the pre-clinical trail research of drug, and so on. It will be strictly administrated on the new drug registration and protection, for example, in the five year-
monitoring period of the new approval drug, it will be not allowed that other pharmaceutical manufacture produces, changes the dosage form and import from oversea; the contents changing in dosage form are newly added in the modified provisions. (SFDA sets up the monitoring period for the new approved drug, it will continually supervise the safety producing and using the new drug.)
 
New drug registration for AIDS will be taken in the fast track of drug registration.
The new Provisions for Drug Registration will much clearly identify the scope of the fast track application for new drug.
 
These new drug registrations for ADIS, malignancy and other rare diseases will bring into the abbreviated new drug application within the fast track process. (2007.03.12)
 
Investigation workshop for the obtaining availability of the essential drugs was held Jinan City of Shandong Province.
 
For better understanding of the situation for the obtaining availability of the essential drugs in China, WHO representative office in Beijing, Ministry of Health of China and SFDA jointly launched this investigation and research. The workshop was held in Jinan city on March 7 to 8, 2007. Five principals from Department of Policy and Regulation and Department of International Cooperation of SFDA, School of Public Health of Shanghai Fudan University had the informal discussion with local government officers who were from the drug administration, the finance department, the price department, the medical insurance companies, the pharmaceutical manufactories and the retail companies, and some representatives of hospital doctors, druggists and patients in Jinan City and Taian City. A wide range of discussion and information exchange was explored in workshop, for instances, the drug policy in China, the current development situation of the essential drug list, the relationship between the essential drug list and the town basic medical insurance drug list, the responsibilities of governments to protect the obtaining availability of the essential drugs and insure the essential drugs in well process of producing, supplying and using. (2007.03.12)
 

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