Pharmaceutical News
TFDA drafts regulations for cell and gene therapies

Cell and gene therapies give hope to some patients suffering from diseases which are currently incurable. The TFDA published the draft of the “Regulations for Governing Cell and Gene Therapies” on the 26th, aiming to ensure the safety of such products.  The draft regulations also include a mechanism for issuing preliminary licenses so as to accelerate patients’ access to new treatments.

Currently, cell and gene therapies are regulated by the Pharmaceutical Affairs Law.  It is necessary to devise special regulations for governing cell and gene therapies on the grounds of their unique characteristics.  The TFDA’s draft regulations define cell and gene therapies, clarify the criteria for donors and establish a mechanism for issuing preliminary licenses to products without safety concerns.

On average, it takes at least 2-3 years for a cell or gene therapy to complete three phases of clinical trials in order to justify the product’s safety and effectiveness.  However, for patients suffering from cancers, rare diseases, neurodegenerative diseases, autoimmune diseases, etc., they don’t have much time to wait for the whole process.

According to the draft regulations, the central competent health authority may issue a 5-year preliminary license to drugs if they have evidence of effectiveness and safety. 

Chi Row-Fong, a TFDA official, expressed that the 5-year preliminary license will allow patients to access the cell or gene therapies which are yet to complete all three phases of clinical trials, but have already proved their safety and generated sufficient data to predict their effectiveness.   After receiving the preliminary licenses, those products still have to continue the clinical trials, submit trial reports to the competent authority and re-apply for the drug licenses before the specified deadline.

The Draft also regulates the qualification of donors and ensures that products are free from the contamination of infectious diseases.

The TFDA released the Draft for a 60-day comment period. After that, the Draft will be submitted to the Executive Yuan for approval, then to the Legislative Yuan for legislation.  The implementation date is not yet clear.

【2017-07-26 / Central News Agency】