国家发改委办公室:求高手帮我翻译

The majority application import chemicals already was allowed in beyond the border to go on the market, has obtained the drugs production country or the local drugs management structure goes on the market the permission, had certain clinical reasonable 用药 to accumulate (after system specification clinical research, goes on the market 用药 experience and re-evaluation understanding and so on).
But also should see, these application imports chemicals the time which go on the market in beyond the border successively different, accumulates the data or/and experiences is different; Beyond the border national and the local clinical research condition, the supervising and managing level are different; The economical and the cultural influence, domestic patient's 疾病谱, disease condition, diagnoses and treats standard and overseas compares sometimes can have the certain difference; The majority of drugs have its corresponding therapeutic dose scope, goes on the market in the instruction for use corresponding content in the new area to need to profit from already the information, the basis specific crowd and its disease situation which has performs to determine; The partial medicines in the different race have more obvious metabolism transformation difference and so on. Therefore, cannot the supposition go on the market the drugs clinical practice information these beyond the border (drugs instruction booklet) to imitate completely to domestically, instructs medical trouble 用药. ICH also elaborated in its E5 guiding principle front goes on the market to the drugs in the new area carries on appraised and carries on the essential clinical test the viewpoint: 1) has time the question to the dosage choice; 2) to accepts the clinical check experiment which the overseas area carries on to have very little experiences or does not have the experience; 3) the medical condition like use assistance treatment and the clinical test design and/or the implementation is different; 4) the new area is not familiar to this medicine type. In these situations should consider conducts the essential clinical research. Thus, the import chemicals conducts the clinical research to have its explicit sense of purpose.
In addition also should point out that, drugs the clinical research which use for the registration has the certain limitation. After the drugs go on the market, follows the massive crowds the application also to be able to expose more valuable information. After the drugs are allowed the registration not to mean the clinical research work the conclusion, regarding goes on the market the product also to be supposed to carry on goes on the market the after following research and the monitor, by consummates its security and/or the valid information. In the application process, the recent information will be able unceasingly increase to the product information in, the product instruction booklet will need regular or non-periodically revises, the renewal. Therefore, the import chemicals clinical research, needs from the registration, to go on the market and so on the process comprehensive ponder, should not only completely concentrate the attention in former.
Second, the import chemicals conducts the clinical research the premise
"Drugs Registration Policing method" (implementation) the seventh chapter (import drugs declaration and examination and approval) the 95th stipulation, "the clinical research after the authorization, the applicant must defer to this means fourth chapter (medicine clinical research) and the related request carries on."
After 1. "must by the national drugs surveillance administrative bureau authorization to implement" (sees also "Drugs Registration Policing method" (implementation) fourth chapter of 24th);
2. "must carry out" Medicine Clinical test Quality control Standard "" (to see also "Drugs Registration Policing method" (implementation) fourth chapter of 24th);
3. uses (sees also "Drugs Registration Policing method" after the examination qualified clinical sample (implementation) fourth chapter 32nd, 33);
4. "the rare sickness, the special sickness plant and other situations, the request reduces the clinical research case of illness number or exempts performs the clinical test, must by the national drugs surveillance administrative bureau examination authorization" (to see also "Drugs Registration Policing method" (implementation) fourth chapter of 27th).

Most chemical medicines imported in application have already got permission to go on the market abroad, have obtained the medicines production country or listing permission of the regional medicines management organization, have certain clinical reasonable administration accumulate , use medicine experience and understanding that appraise ,etc. list ,).
But should see , the time that chemical medicines imported in these applications went on the market abroad was successively different, it is for ones that accumulate data or /with experience; The external country is different from the clinical research condition of the area , supervision level; Affect by economy and culture, domestic disease table , disease state , make a diagnosis compared with foreign countries sure difference stores in sometimes in the standard of patient; Most medicines have their corresponding dosage ranges, the corresponding content listed on new area in the operation instructions needs to draw lessons from existing information , confirm according to the particular crowd and his disease situation; There is comparatively obvious supersession that transform difference ,etc. in different race in some medicines. So, can't suppose that all imitate the clinical practice information (the medicines manuals ) of these external already listing medicines to our country, to instruct doctors and patients how to use medicine. ICH has explained too in their E5 guidelines that carry on the assessment and carry on the view of the essential clinical trial to medicines before the new area is listed: 1)While choosing to have doubt to the dosage; 2)To accept foreign clinic that area carry on contrast test have few experience or have experience; 3)Whom if medical terms use assist and treat different from design and/or implementation of the clinical trial; 4)The new area is not familiar with this medicine type. In these cases should consider carrying on essential clinical research . Therefore import chemical medicines go on clinical research have his clear purpose.
In addition should point out , the clinical research for registering and using of medicines is limited. After medicines are listed, the application which follows a large number of crowds will expose more valuable information . End not meaning clinical research work after medicines get permission to register, should also carry on follow-up study and monitoring after going on the market to the listing products, in order to improve its security and/or validity information. In the course of employing, new information will load in the product information constantly, the catalogue needs to revise , upgrade fixedly or irregularly . So, import the clinical research of chemical medicines, need thinking from the course of registering , listing etc. in an all-round way, should not only concentrate all attention on the former .
Two, import the chapter seven (declaration and examination and approval of importing medicines ) 95th regulation that " medicines register management " (try ) of prerequisite of going on clinical research of chemical medicines, " clinical research is upon approval, the applicant should go on according to chapter four of this method (the clinical research of the medicine ) and relevant requirements . " 1. " must implement after State Pharmaceutical Inspection Administration sanctions " (see " medicines register management " (try ) article 24 of chapter four); 2." must carry out " medicine clinical trial quality standardard management " " (see " medicines register management " (try ) article 24 of chapter four); 3. Use up to the standards clinical sample (see " whether medicines register management " chapter four 32 , 33); 4."are ill , special number and other situation, demand , reduce clinical research case number or exempt , make clinical trial, must examine and approved by State Pharmaceutical Inspection Administration " (see " medicines register management " (try ) article 27 of chapter four ).

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