Business Club reported on December 22 that the signing of the "Straits Medical and Pharmaceutical Cooperation Agreement" is a major plus for the pharmaceutical companies on both sides of the Taiwan Strait. Clinical trials and non-clinical testing of pharmaceuticals on both sides of the Strait, as well as pre-marketing review, production management, and listing Post-approval and other links will gradually adopt the results of each other's implementation, which will effectively promote cross-strait pharmaceutical production R&D 'seamlessly docking',†Yu Mingde, president of the China Pharmaceutical Enterprise Management Association, said in an exclusive interview with Xinhua News Agency.
On the 21st, the ARATS and the SEF signed the "Straits Medical Cooperation Agreement" in Taipei. As the longest chapter in the agreement, “Pharmaceutical Safety Management and R&D†has been widely appreciated by people in the industry.
“The two sides have their own strengths in the R&D of pharmaceutical products. The signing of the agreement provides a rare opportunity for the two sides of the Taiwan Strait to learn from each other.†Yu Mingde analyzed that the level of GMP (Manufacturing Quality Management Practices) of many pharmaceutical factories in Taiwan is higher than Mainland China, the experience and ability to explore the international market is also better than the mainland, it is worth to learn from the mainland pharmaceutical companies. Compared to Taiwan, the mainland has a strong clinical hospital, disease research institutes, there are sufficient bone marrow libraries, gene banks, these are It is a resource that Taiwan can not ignore in terms of improving the level of pharmaceutical research and development.
“In the past, both sides of the strait had 'sayed different things' in terms of clinical trials of pharmaceutical products, handling of security incidents, certification of R&D technology, and approval of market access. Substantial exchanges and cooperation were difficult to carry out. Now, the signing of the agreement is all about this. Clearing the obstacles, both sides of the Strait can effectively dock under the same standards and regulations,†Yu Mingde said happily.
According to Lian Ruimeng, Honorary Director of the Taiwan Pharmacists' Federation, the significance of “gradually identifying each other’s implementation results†is also to significantly reduce the manpower and material costs of new drug access, and provide patients with more timely and convenient treatment.
He said: “In the past, both sides of the strait had done different things, and many medicines passed non-clinical tests and clinical trials in Taiwan, but they have to go through the same formalities on the mainland. A new drug has to wait at least two or three years and cost hundreds of millions of yuan. With this agreement, Taiwan's various tests and tests have gradually been recognized by the mainland, and market access procedures have been greatly simplified."
Taiwan’s “Commerce and Industry Times†also stated that after the signing of the medical cooperation agreement, cross-strait clinical trial cooperation will be possible for the two sides to jointly develop new drugs and new medical devices. The clinical trials completed at the Taiwan Pharmaceutical Factory need not be heavy to enter the mainland market. To do this is more advantageous to developing biotech companies on the island.
"On the mainland market, only over 50% of the raw materials for infusion bottles are imported from Taiwan. Professionals estimate that once cross-strait access standards for mutually acceptable medicines are established, it will bring the pharmaceutical industry in Taiwan to dozens of times more than the current expansion. The increase, "said Feng Guoping, vice president of the China Pharmaceutical Packaging Association.
On the 21st, the ARATS and the SEF signed the "Straits Medical Cooperation Agreement" in Taipei. As the longest chapter in the agreement, “Pharmaceutical Safety Management and R&D†has been widely appreciated by people in the industry.
“The two sides have their own strengths in the R&D of pharmaceutical products. The signing of the agreement provides a rare opportunity for the two sides of the Taiwan Strait to learn from each other.†Yu Mingde analyzed that the level of GMP (Manufacturing Quality Management Practices) of many pharmaceutical factories in Taiwan is higher than Mainland China, the experience and ability to explore the international market is also better than the mainland, it is worth to learn from the mainland pharmaceutical companies. Compared to Taiwan, the mainland has a strong clinical hospital, disease research institutes, there are sufficient bone marrow libraries, gene banks, these are It is a resource that Taiwan can not ignore in terms of improving the level of pharmaceutical research and development.
“In the past, both sides of the strait had 'sayed different things' in terms of clinical trials of pharmaceutical products, handling of security incidents, certification of R&D technology, and approval of market access. Substantial exchanges and cooperation were difficult to carry out. Now, the signing of the agreement is all about this. Clearing the obstacles, both sides of the Strait can effectively dock under the same standards and regulations,†Yu Mingde said happily.
According to Lian Ruimeng, Honorary Director of the Taiwan Pharmacists' Federation, the significance of “gradually identifying each other’s implementation results†is also to significantly reduce the manpower and material costs of new drug access, and provide patients with more timely and convenient treatment.
He said: “In the past, both sides of the strait had done different things, and many medicines passed non-clinical tests and clinical trials in Taiwan, but they have to go through the same formalities on the mainland. A new drug has to wait at least two or three years and cost hundreds of millions of yuan. With this agreement, Taiwan's various tests and tests have gradually been recognized by the mainland, and market access procedures have been greatly simplified."
Taiwan’s “Commerce and Industry Times†also stated that after the signing of the medical cooperation agreement, cross-strait clinical trial cooperation will be possible for the two sides to jointly develop new drugs and new medical devices. The clinical trials completed at the Taiwan Pharmaceutical Factory need not be heavy to enter the mainland market. To do this is more advantageous to developing biotech companies on the island.
"On the mainland market, only over 50% of the raw materials for infusion bottles are imported from Taiwan. Professionals estimate that once cross-strait access standards for mutually acceptable medicines are established, it will bring the pharmaceutical industry in Taiwan to dozens of times more than the current expansion. The increase, "said Feng Guoping, vice president of the China Pharmaceutical Packaging Association.
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