Medical and health cooperative agreement of both sides of Taiwan Strait

Medical and health cooperative agreement of both sides of Taiwan Strait
Medical and health cooperative agreement of both sides of Taiwan Strait
Originally the health value to the maintainer, ensure the health rights and interests of the people of two sides of straits, promote cooperation of medical and health of two sides and development, matters concerning cooperation of the medical and health of two sides of Strait Exchange Foundation of of the legal person of Association for Relations Across the Taiwan Strait and financial group, through holding consultations on an equal footing, reach an agreement as follows: Chapter one The general provisions one, field of cooperating Both sides agree to carry on exchange and coorperation in the field of the following in line with the equal principle of reciprocity: (1) Infectious disease is prevented and cured; (2) Safety management of the medical product and researching and developing; (3) Study and exchanging and Chinese medicinal materials safety management in traditional Chinese medicine; (4) Treat and cure promptly; (5) Other fields that both sides agree. Second, way of cooperating Both sides agree to carry on medical and health business exchange and cooperation in following way: (1) Promote the fixed work meetings of personnel of responsible institution of business, investigate that joins visiting, exchange of technology and holding the seminar etc.; (2) Exchange, notify, inquire and announce relevant business information, normal and actual operation measure of system; (3) Other cooperation ways in which both sides agree. Third, this agreement of contacting the subject discuss and decide the item, the contact appointed from both sides' relevant business responsible institution connects each other and implements. If necessary, get the permission of both sides so as to appoint other units to carry on the connection. Other relevant matters of this agreement, are got in touch by the Strait Exchange Foundation of of the legal person of Association for Relations Across the Taiwan Strait and financial group. Fourth, both sides of work planning agree to set up the following work groups separately, responsible for agreeing concrete work planning, scheme: (1) Prevent and cure the work group in infectious disease; (2) Safety management of the medical product and researching and developing the work group; (3) Study and exchanging and Chinese medicinal materials safety management work group in traditional Chinese medicine; (4) Treat and cure the work group promptly; (5) Work group of inspection and quarantine; (6) Other work groups which both sides agreed to set up. Every work group should hold meeting until agreement this come into force, discuss information exchange and notify project, content, form, frequency and contact window relevant matters. If necessary, every work group must agree to alter the relevant matters, and must have the work and divide into groups separately. Chapter two Prevent and cure five, range of cooperating in infectious disease Both sides agree to influence quarantine and epidemic prevention of the healthy infectious disease of the people of two sides, information exchanges and notifying, great infectious disease handling, vaccine researching and developing and other items of epidemic situation, carry on exchange and cooperation. Infectious disease range, classification and agrees to handle in accordance with each regulation of both sides. 6th, quarantine with the normal key ability of the epidemic prevention criterion of applying generally acknowledging to quarantine of the epidemic prevention measure by mutual consent, strengthen cooperation, take the essential quarantining and epidemic prevention measure, avoid or reduce infectious disease to propagate to the other side. Both sides agree to find the other side suspected or make a definite diagnosis of the infectious disease patient in the one's own side, carry on appropriate treatment or assistance and return to the original residence treatment. Seventh, infectious disease epidemic situation information is exchanged and circular should exchange information such as epidemic situation of infectious disease and health quarantine fixedly each other in written way at ordinary times by mutual consent. Both sides agree to notify as soon as possible that perhaps or already it is great to form and happen suddenly the infectious disease epidemic situation of the public health event, and communicate and notify the relevent information continuously. If obtaining the other side to inquire about, should respond and assist as soon as possible. Great epidemic situation notify content, the intersection of case and definition, the intersection of laboratory inspection and data, the intersection of epidemic situation and source, case count, prevention measure,etc. that death count and take. If necessary, both sides get agreeing the alteration notifies the content. Have the other side people take place great the intersection of epidemic situation and information that side is infect, this side should notify the other side. Eighth, great epidemic situation handle, take place great the intersection of epidemic situation and side, should take, monitor and handle the measure effectively immediately; If necessary, must ask the other side to offer assistance actively. The great epidemic situation side takes place, when the other side asks, should offer the situation of investigation of the epidemic situation, and consider and assist the other side to find out about epidemic situation on the spot actively. Nine, the common infectious disease deeply concerned is prevented and cured, exchanged, agreed to prevent and cure the tactics with the two sides concerned on the common infectious disease deeply concerned, standard of quarantining, the intersection of treatment and measure, and affair carry on the exercise of, examine technology and the intersection of laboratory and sample and vaccine, research and develop etc. actually, carry on exchange and cooperation. Chapter three Safety management of the medical product and researching and developing ten, range of cooperating The refered medical product of this agreement, mean medicines, medical apparatus, health food (healthy food) And the cosmetics, excluding Chinese medicinal materials. Both sides agree to system norms such as management,etc. on non- clinical detection, clinical trial, checking before going on the market, production management of the medical product of two sides, after going on the market, and technical standard, test technology and other relevant items, carry on exchange and cooperation. Medical product item of the following two sides that 11, quality and both sides of safety management agree, establish cooperation mechanism: (1) It is not a standardard management of the clinical trial (GLP) , the standardard management of clinical trial (GCP) And produce the standardard management (GMP) Inspection; (2) Bad reaction and bad incident notify, treatment and tracking; (3) The false, bad, prohibit and check of the medical product of violation, and exchange information and is traced back to its source. 12, association's place mechanism set up association's place mechanism of safe incident of the great medical product of two sides by mutual consent, take the following measures to deal carefully with: (1) Consult promptly, exchange the relevent information; (2) Take the control measure, prevent the state of affair from spreading; (3) Offer and understand the facility on the spot; (4) Verify that releases information, and notify each other; (5) Offer the incident reason to analyze, notify investigation and result in time; (6) Supervise the manufacturer that should be responsible and person in charge to deal carefully with the dispute, and is damaged the guarantee of manufacturer and consumer rights and interests, assist actively. 13, standard norms are coordinated Both sides agree to generally acknowledge the standard (ICH, GHTF,etc.) in the safety management of the medical product Principle under,strengthen cooperation,is it of both sides to actively promote technical standard and that standardize harmony, in order to promote the security, validity of the medical product. On the basis of the aforesaid, examine, examine and approve (check and register) the medical product And produce the standardard management and check cooperation, canvass and adopt the result that the other side carries out progressively. 14, relevant system norm of each other's clinical trial that the two sides concerned agree to the clinical trial, executive body and carries out the management of the group, is guaranteeded by rights and interests of persons who try and verified the mechanism etc. with the clinical trial planning and test resulting, carry on exchange and cooperation. According with the standardard management of the clinical trial (GCP) Under the standard, regard reducing repeated experiments as the goal, have priority by way of pilot project and special project, actively promote two sides clinical trial and The medical product researches and develops cooperation, and on this basis, canvass and accept the result that both sides carry out progressively. Chapter four Research of traditional Chinese medicine and exchange? Father's good fortune Step on �� Fei in the footpath between fields? 15, cooperate range make a diagnosis the intersection of method and research, the intersection of traditional Chinese medicine and academic research and other relevant items on the intersection of Chinese medicinal materials and the intersection of quality and safe sageguard measure, traditional Chinese medicine by mutual consent, carry on exchange and cooperation. 16th, quality is safe Both sides agree to carry on the following cooperation: (1) Exchange and coorperation of Chinese medicinal materials quality safety standard and method of inspection; (2) Assist Chinese medicinal materials to examine the documentary evidence to check and confirm each other. 17th, output and examine the measure and take measures by mutual consent, it accords with the safe requirement of quality to ensure transporting to the other side's Chinese medicinal materials: (1) Inputting the side should notify and output square latest system norm, test stone, detection method and limit to require in time, and is exported and then transfer to knowing relevant organization and enterprise, require enterprises to Chinese medicinal materials transported to the other side, obtain and examine the documentary evidence, the guaranteed quality and security in accordance with inputting the square requirement; (2) Exporting the side should examine Chinese medicinal materials declared, exported, and to inputting the safe project not up to standard of quality that the side notifies many times, export examining intensively according to the need. 18, notifying and association's place mechanism set up great security incident, bad reaction and quality safe problem notifying and association's place mechanism of Chinese medicinal materials of two sides by mutual consent, and the measure is dealt carefully with definitely in accordance with article 12. 19, traditional Chinese medicine are studied and exchanged to both sides and agreed to agree to study and exchange the preferential collaborative project in traditional Chinese medicine together, set up and exchange the platform, hold exchange activity actively, bring about an advance in traditional Chinese medicine. Chapter five Treat and cure 20, range of cooperating promptly Both sides agree on the intersection of two sides and great accidental event to treat and cure measure, the intersection of information and exchange and the intersection of sick and wounded and the intersection of person who pass on to and item promptly sick and wounded, carry on exchange and cooperation. 21, treat and cure measure by mutual consent to in the intersection of one's own side and caused by great accidental event the intersection of the other side and people of wound promptly, offer and treat and cure promptly, assist to arrange to accept the hospital for medical treatment and and take other appropriate medical measures. 22nd, treat and cure information and exchange both sides to agree the side happens in the great accidental event promptly, should offer the other side the intersection of sick and wounded and register, injure the condition shape, accept hospital and contact detail for medical treatment as soon as possible, and the other relevent information. The 23, urgent sicks and woundeds pass on to assisting both sides to agree the side happen in the great accidental event, when the other side asks, should assist to handle the sick and wounded to pass on to the matters actively. Chapter six Supplementary provisions 24, secret obligation Both sides agree secret and other information are kept secret for carrying out the personal materials that the relevant activity of this agreement obtains, opening. But in accordance with the request purpose user, are not subject to the limits. 25th, restrain the use from only in accordance with asking the purpose to use the materials that the other side offered by mutual consent. But both sides have stipulators besides, are not subject to the limits. 26, document's form information exchanging, notifying, inquiry and business relations,etc. by mutual consent, use the document form agreed. 27, agreement fulfil and alter both sides and should abide by the agreement. The alteration of this agreement, should be decided by consent of both sides, and confirm in written form. 28, solution to disputes grow the dispute as applicable to this agreement, both sides should resolve through consultation as soon as possible. Besides having other agreements, should hold to consult in 15 workdays after asking to propose. 29, if this agreement of unaccomplished matter have unaccomplished matter, both sides must agree separately in appropriate way. 30th, after signing this agreement of coming into force to sign, both sides should finish the relevant procedure and inform the other side in writing respectively. This agreement had come into force from next day since both sides receive the other side's notice. This agreement is signed on December 21, in quadruplicate, each side holds two. The cross-Straits relations Straits of legal person of financial group Association Exchange the foundation President Chen Yunlin Chairman Jiang BingKun (Taibei, December 21 (Xinhua))


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