Pharmaceutical News
KMU Taipei Forum: Regulations should be adjusted to facilitate the development of precision medicine

Reported by Liu Chia-Yun and Chang Yi-Hua


The development of precision medicine has become a worldwide trend, attracting the attention of all governments.  For example, the former US President Obama proposed a plan known as the “Precision Medicine Initiative” in 2015.  The Taiwanese government has joined the trend and established the gene databank, as well as formulated plans to adjust the regulations to bring them into line with the advance of technology so that laboratories, researches, medicines and medical devices can move towards the direction of personalization.  The government hopes that in the future the public can enjoy the benefit of personalized precision treatments.


Dr Shih Chung-Liang, Director or the Department of Medical Affairs of the MOHW, pointed out that as the population is ageing and suffering from multiple chronic conditions, the introduction of smart medical treatments can help the government to cope with the increasing medical demands and improve the quality of care.  The academia predicts that in 2 to 3 years, AI, big data and IOT will be integrated to radically change the care system.  At present, the care system is based on treatments in hospitals.  In the future, long-distance and personalized precision medicine will be available.  The care system will shift its mission from curing diseases to improving health.


Dr Shih continued that the MOHW is planning to adapt the regulations of precision medicine.  Regulations of regenerative medicine and cell therapies have been drafted to regulate the medicinal products.  For personalized medicine, special regulations are required to oversee the molecular laboratories, the personnel, their qualifications, venues and conditions.


The TFDA has announced the draft of the “Regulations Governing Cell/ Gene Therapy Products”.  According to the draft, a temporary license may be granted to cell/ gene therapy products so that patients can quickly access the products on a conditional basis.  Dr Wu Shou-Mei, Director –General of the TFDA, expressed that the R&D cost of precision medicine is quite high; however, it can increase the cure rate and reduce the overall medical costs.


In addition to prevention and diagnosis, personal care is another aspect of precision medicine.   For example, wearable devices can help monitor and control patients’ conditions.  According Lai Po-Hsiung, the president of a long-distance care provider, personalized care can be provided for patients on a 24-7 basis by nurses and carers through a long-distance monitoring system.  The system will collect and analyse patient’s data to detect any abnormality.


Humanity is one of the issues concerning the development of precision medicine.  Chiang Hong-Che, Secretary General of the NHRI, expressed that the baby boomers have good education and financial status; however, they are susceptible to chronic diseases and long illnesses.  The development of the care system should focus on the demand of this ageing group so as to provide good care and help them to keep independence.


【2017-09-24/ United Daily News】