The draft of Regulations Governing Regenerative Medicinal Product was approved by the Executive Yuan and submitted to the Legislative Yuan for review in October 2018.  However, the review has been delayed due to the debate over the definition of regenerative medicinal products. Therefore, on the 12th, the Legislative Yuan held a public hearing on this draft. 

Representatives of the patient groups, the academic and the industry all attended this public hearing, aiming to establish a sound regulatory environment for regenerative medicinal products.  The participants include delegates from the Taiwan Cancer Immune Cell Treatment Association (TCICTA), the Formosa Cancer Foundation, the Formosa Foundation Regenerative Medicine, the Society for Stem Cell Research, the Taiwan Association for Cellular Therapy and many international and local drug companies.  Dr Chen Shih-Chung, the MOHW Minister, also attended the meeting to listen to the stakeholders’ comments.  Dr Chen pointed out that the MOHW will try to find a common ground and work from there to promote the legislation of the Regulations.

The main topic of this public hearing is about the definition of regenerative medicinal products.  In last legislative session, there was a heated debate about whether it refers to preparations or products.  The definition not only concerns stakeholders’ interests, but also requires different level of regulations and administration.  For example, if it refers to preparations, then the TFDA will be the competent authority; however, if it refers to products, then the MOEA will be in charge.  There was also debate about a flexible definition which includes both technology and devices into the scope.  In that case, the Medical Act, the Pharmaceutical Affairs Act, the Medical Devices Act, etc. will all be relevant.    As a result, it will require a long and complicated legislation process.

In Japan, a dual system is implemented. The Medical Affairs Council of the Ministry of Health, Labour and Welfare in Japan is in charge of medical technology; and the Pharmaceutical and Food Sanitation Council is in charge of pharmaceuticals and medical devices.  At present, Taiwan is also following a dual system by implementing two sets of regulations for medical technology and pharmaceutical products respectively.   In Korea, the US and the EU, regenerative medicinal products are managed as pharmaceutical products.

However, it is difficult to clearly differentiate between medicinal products and medical conducts and apply relevant regulations accordingly as it provokes conflicts among stakeholders. 

【2020-05-12 / Economic Daily】