KMT Legislator Lin Weizhou, Times Power Legislator Chen Jiaohua, together with the National Federation of Pharmacist Associations of the Republic of China, the National Federation of Pharmacist Associations of the Republic of China, and the Hsinchu County Pharmacist Association held a press conference on "The second law of regeneration should implement professional division of labor and strict regulation" meeting.

(Photo by reporter Wang Qianhao)

[Reporter Wang Qianhao/Taipei Report] The Social Welfare and Health Environment Committee of the Legislative Yuan will review the "Regenerative Medicine Act" and "Regenerative Medicine Preparations Bill" one by one tomorrow. Legislators from all parties and pharmacists held a press conference today to express relevant demands .

The National Federation of Pharmacist Associations of the Republic of China issued a four-point statement, including that "regenerative medical preparations are drugs, and there is no room for ambiguity." The review committee should clearly include experts in medicine, pharmacy, and legal ethics.

KMT Legislator Lin Weizhou, Times Power Legislator Chen Jiaohua, together with the National Federation of Pharmacist Associations of the Republic of China, the National Federation of Pharmacist Associations of the Republic of China, and the Hsinchu County Pharmacist Association held a press conference on "The second law of regeneration should implement professional division of labor and strict regulation" meeting.

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Lin Weizhou pointed out that the National Federation of Physician Associations of the Republic of China and the National Federation of Pharmacists have different views on whether "preparation" should be under the management of the Pharmaceutical Affairs Law, and what role the "review committee" should play.

The National Physician Association believes that "regenerative medicines are different from general medicines." However, the National Federation of Pharmacists believes that this authority belongs to the authority and responsibility of the competent authority Food and Drug Administration.

Lin Weizhou said that regenerative medicine is an emerging field, and he is happy to see that the second law on regenerative medicine can be read for the third time as soon as possible. However, the government's attitude should be firm. It must be based on the protection of the health of the Chinese people, and it must avoid continuous disputes between professional groups and entangle the public in misunderstanding and confusion. .

Lin Weizhou called on the government to set up an inter-ministerial (Ministry of Health and Welfare, Ministry of Education) platform to discuss and formulate the qualifications of physicians, pharmacists and other medical personnel after the second reading and third reading of the regenerative medicine law, and the requirements for in-school education and continuing education. The content of the training is to establish the clarity of professional division of labor and responsibilities, and to ensure the quality of executive personnel.

Chen Jiaohua said that regenerative medical preparations are drugs referred to in Article 6 of the Pharmaceutical Affairs Law, and should have been managed in accordance with the current Pharmaceutical Affairs Law and the division of labor between pharmaceuticals.

She has a background in pharmacy and pharmacists. For the emerging regenerative medicine and regenerative medicine preparations, it is indeed different from traditional general medicines, but she supports the management of drug affairs law, and let pharmacist representatives participate in the regenerative medicine deliberations, and emphasizes the education and development of medicine. Continuing education should be included in the study of regenerative medicine related fields.

Huang Jinshun, chairman of the National Pharmacists Association, said that regenerative medical preparations conform to the definition of drugs in my country's Pharmaceutical Affairs Law. Even if a special law is formulated, it cannot deviate from the basic principles of drug management, and the international trend is the same.

Pharmacists are responsible for the dispensing, supervision, and drug management of drugs. This is a well-established legal system in our country, and it is also the responsibility and obligation of pharmacists.

In addition, regenerative medicine is more unstable than ordinary drugs, and its curative effect is more uncertain. Only by implementing professional division of labor, multi-level checkpoints, and strictly drawing the dividing line between technology and preparations can the rights and interests of the public be protected. Regenerative medicine, in particular, is expensive, and legislation must be more cautious .

Zhang Wenjing, chairman of the Taipei Pharmacists Association, said that there is a consensus around the world that regenerative preparations are medicines, and there must be requirements from the beginning of the manufacturing process in order to truly ensure the quality of regenerative preparations.

Since regenerative preparations are manufactured using living cells, the process is more cumbersome and even complicated than ordinary drugs; from cell collection to processing and mass production, supervision and management cannot be looser than drugs, so it must be more complex than drugs. Drugs are more rigorous.

The National Federation of Pharmacists issued a four-point statement: 1. Regenerative medicine preparations are drugs, and there is no room for ambiguity; , legal ethics and other experts; 4. In order to follow the principle of "risk stratification and strict regulation", the application for exclusion of drug certificates should be added with a procedure of "requiring deliberation by a special committee".