Taiwan's new drugs will be on the market in the mainland as soon as the end of the year

Xu Mingneng, vice president of the Ministry of health and welfare, said that at present, one new drug in Taiwan has completed three phases of clinical trials and entered the stage of final inspection, registration and review It is expected that it will be listed on the mainland by the end of this year and the beginning of next year; another new drug is undergoing the third phase of clinical trials and three new drug cases are being applied for Xu Mingneng said that the average time from research and development to market of new clinical drugs is 5 to 10 years At present, through the agreement, new drugs can progress from clinical phase 1 to phase 3 in three years, which has greatly shortened the time of drug research and development and review Through the negotiation platform, special review is believed to accelerate the time of new drugs to market in the mainland The cross strait medical and health cooperation agreement came into force in June 2011 The two sides agreed to exchange and cooperate on the non clinical detection, clinical trial, pre market review, production management, post market management and other system specifications of cross strait medical products, as well as technical standards, testing technology and other related matters Both parties agree to exchange and cooperate with each other on the relevant system and specification of clinical trial, management of executive agency and executive team, rights and interests protection of subjects, clinical trial plan and trial result audit mechanism, etc In line with the standard of clinical trial management (GCP), with the goal of reducing repeated trials, priority should be given to promoting cross-strait clinical trials and pharmaceutical research and development cooperation in the form of pilot and project, and on this basis, to explore the results of gradual acceptance of implementation by both sides Original text: Taiwan's new drugs will be launched at the end of the year as soon as possible http://gb.chinatimes.com/gate/gb/ The cross strait medical and health cooperation agreement came into effect in June 2011 The Ministry of health and welfare said yesterday that Taiwan expects new drugs to be listed on the mainland by the end of this year and the beginning of next year However, the DPRK and the opposition legislative committee bombarded the agreement for nearly three years Taiwan's biotechnology industry has obviously kicked the iron plate in the mainland, and the regulations of both sides still fall behind, so negotiations should be restarted The Ministry of health and welfare, the Ministry of economy and the Land Commission went to the social and Environmental Committee of the legislative yuan yesterday morning to report on the cross strait medical and health cooperation agreement Xu Mingneng, vice president of the Ministry of health and welfare, said that at present, one new drug in Taiwan has completed three clinical trials and entered the stage of final inspection, registration and review It is expected that it will be listed on the mainland by the end of this year and the beginning of next year Another new drug is undergoing the third clinical trial and three new drug cases are being applied for However, Liu Jianguo, a member of the Legislative Committee of the Democratic Progressive Party, bombarded Taiwan The report of the Land Committee clearly pointed out that our clinical trial laws and regulations are in step with the international norms such as the international pharmaceutical Law Association (ICH), but there is still a gap between the mainland laws and regulations and the international norms, which often leads to various obstacles for Taiwan's biotechnology industry to enter the mainland He said that at the time of the signing of the agreement, it was claimed that the listing of new drugs in Taiwan could be shortened However, in the past three years, Taiwan has been stuck in relevant regulations and cannot successfully enter the mainland market Should the Ministry of health and welfare restart negotiations? Cai Jinlong, a member of the Standing Committee of the Kuomintang, said that the access to the mainland of Taiwan's biotechnology plants is still not smooth, and the effectiveness of the agreement is discounted Tian Qiuxu, a member of the Standing Committee of the Democratic Progressive Party, questioned that the two sides have been running through the drug R & D laws and regulations for three years since the agreement was signed Why didn't they negotiate before signing it? Xu Mingneng responded that it takes an average of 5 to 10 years for clinical new drugs to go on the market from research and development At present, through the agreement, new drugs can progress from clinical phase 1 to phase 3 in three years, which has greatly shortened the time of drug research and development and review Through the consultation platform between the government and the government, special review is believed to accelerate the time of new drugs going on the market in the mainland.