Cell and Gene Therapy Medicinal Product  
Management Act (Draft)  
General Information  
July 2017  
 
At present there are still many diseases that cannot be cured by 
current medical technology  and existing chemical or biological drugs ; 
therefore, all relevant circles hope that perfect treatment can be provid ed 
at an early date through research and development in advanced medical 
technology and medicinal products. The m edical and pharmaceutical 
circles and biotechnology industry  play a leading active  role involved in 
the research and development of advanced medical technology and 
medicinal products in seeking a breakthrough in the treatment of human 
diseases, to benefit numerous patients by reliev ing their pain, and 
improv ing their living quality. So, the development of cell therapy 
medicinal products or gene therapy -related  medicinal products plays a 
key role, and brings a glimmer  of hope  of being cured to many patients.  
 
Hence, it is necessary to enact  regulation s for the medical and 
pharmaceutical administration s to ensure the quality, safety and efficacy 
of cell and gene therapy medicinal products, in order to promote patients’ 
rights, safeguard public health, and prov ide a clear and explicit legal 
environment that can mediate the existing relevant regulations to urge the 
researchers and developers of cell and gene therapy medicinal products to 
abide by them . 
 
Thus, t he U.S. Food and Drug Administration (hereinafter referred to 
as the “FDA”), based on the legislative authorization by the  Public Health 
Service Act (hereinafter referred to as the “PHS Act”) made by Congress, 
enact ed the Regulation for the 21 Code of Federal  Registration 
(hereinafter referred to as the “CFR”) Part 1271, not only giving  a 
common name as “human cells, tissues, and cellular or tissue -based 
products ” (hereinafter referred to as the “HCT/Ps”)  to the cell therapy and 
gene therapy medicinal product s and the definition thereof , but also  
formulat ing different laws and regulations according to the risk levels of 
HCT/Ps, as well as explicit stipulations regarding the  procedures and conditions  for selling on the market . Besides, the European Union issued 
Directive 2003/63/EC in June 2003 to amend Directive 2001/83/EC, 
officially prescrib ing the gene therapy medicinal product (GTMP) and 
somatic cell therapy medicinal product (CTMP) as advanced therapy 
medicinal product (ATMP), and the information required to be submitted 
when applying for selling on the market.  In 2007 , it also  promulgate d the 
Regulation 1394/2007 with direct binding force on member countries , 
and then formally included the tissue engineered medicinal product 
(TEMP) in the scope  of ATMP, with clearly stipulated documents and 
procedures necessary for review concerning  ATMP products  to be sold on 
the market.  Japan , on the other hand,  revised the former Pharmaceutical 
Affairs Law, and formulated the law related to ens ure the quality, efficacy 
and safety of pharmaceuticals, medical devices  and others  
(Pharmaceutical and Medical Device Act , PMD Act ). In addition to  the 
original regulations concerning  pharmaceuticals and medical devices, 
definitions and a special chapter  were added for tissue engineered 
product s, cellular therapy product s and gene therapy product s 
(collectively called  “regenerative medicine and other  products ”), with 
explicit stipulations regarding the “licensing” procedures  for 
manufacturing and selling , manufacturing , and selling industries in 
relation to manufacturing and selling  “regenerative medicine and other  
products ” and the “ ratification ” procedures before review for  
“regenerative medicine and other  products ” to be sold  on the market , with 
requirem ents on  quality, effectiveness and safety ; even the so-called  
“ratification  system subject to  certain condition s or time” was formulated 
concerning the review  for “regenerative medicine and other  products ” to 
be sold on the market  
 
In summary, the Cell and Gene Therapy Medicinal Product 
Management Act was drawn up with reference to relevant  legislation at 
home and abroad , including the United States, Europe, Japan , etc . 
Besides, taking into consideration the characteristics of cell and gene 
therapy medicinal products and the situation of their actual medical use, 
cell and gene therapy medicinal products with human cell processing 
should comply with the provisions of the Act . However , for cell therapy  
without  processing or in vitro cell culture procedure  in the  cell manufacturing or operational process , and if the operational process does 
not change the original biological characteristics of the cells, it shall not 
be govern ed by the Management Act. Any other m atters not covered in 
the Act, such as manufacturer and seller management, issuance or 
extension of the permit license, disclosure  information and patent 
protection, product labelling, package leaflet, packaging and marking 
management, safety monitoring, reporting of adverse reactions, audit  and 
banning, etc., shall be handled according to the Medical Care  Act, 
Pharmaceutical Affairs Act and other relevant laws and regulations. The 
main  points of the Act are as follows:  
 
Article  Description  
Article 1 ( Legislative purpose)  
The Act is enacted to ensure the 
quality, safety and efficacy of cell and 
gene therapy medicinal products, and to 
prevent the introduction, transmission  
and spread of infectious diseases caused 
by the use of the products. Any other 
matters not prescribed i n the Act shall be 
governed by relevant laws and 
regulations . To ensure the quality, safety and efficacy 
of cell and gene therapy medicinal 
products, and to prevent the 
introduction, transmission  and spread of 
infectious diseases caused by the use of 
the p roducts, the legislative purposes for 
the cell and gene therapy medicinal 
products  as set forth in  the U.S. ’s 21 
CFR 1271, Japan ’s Pharmaceuticals and 
Medical Device Act and EU’s 
Regulation 1394/2007 are referred  to; 
ensur ing the quality, safety and efficacy 
of the cell and gene therapy medicinal 
products,  as well as prevent ing the 
introduction, transmission  and spread of 
infectious diseases caused by the use of 
the products are listed under  the 
legislative purpose of the Act.   
Article 2 (Competent authority)  
“Competent authorities  of health ” 
in this Act mean the Ministry of Health 
and Welfare at the central level; the 
municipality governments at the 
municipality level; and the county (city) Competent authorit ies at the central and 
local level s in this Act  are explicitly 
prescribed . governments at the county (city) level.  
Article 3 (Terms and definitions)  
Terms and Definitions  in this  Act 
are described as follows : 
1. The term “cell therapy medicinal 
product” in this Act means a 
product obtained through 
process ing on human cells to 
obtain a diagnostic, 
therapeutic or preventive 
effect of human diseases.   
2. The term “gene therapy 
medicinal product” in this Act  
means a product that makes 
the human body have a 
recombinant g ene to obtain a 
diagnostic, therapeutic or 
preventive effect of human 
diseases.  
3. The term “tissue engineered 
medicinal product” in this Act  
means a product with human 
cells being processed so that it 
can have tissue structure or 
function to transplant, repair 
or reconstruct human tissues 
or organs.  
4. The term “cell and gene therapy 
medicinal product business” in 
this Act  means manufacturing 
and selling  the cell or gene 
therapy medicinal product.  1. This Article is about the definitions of 
the cell and gene therapy medicinal 
products. Comprehensive 
references are made to the U.S. ’s 
21 CFR 1271, Japan ’s 
Pharmaceuticals and Medical 
Device Act and the EU’s Directive 
2003/63/EC and Regulation 
1394/2007.  
2. The term “process ing” means the 
handling methods , such as making 
cell proliferation or differentiation 
in vitro, transformation of cell 
activity or biological 
characteristics, cells mixed with 
non-cellular components or cells 
attached to non -cellular 
components, making cell s into 
slices  or stack s, or making  cells 
contain or show foreign gene s. 
3. According to  the management of  
pharmaceutical firms  required by 
the Pharmaceutical Affairs Act, the 
firms  engaged in the manufacturing 
and selling  of cell and gene therapy 
medicinal products are collectively 
called  the firms of cell and gene 
therapy medicinal product s. 
 
Article 4 (Ensure the suitability of 
donors)  
The suitability of donors should be 
guaranteed in R&D and manufacturing 1. This Article is formulated to protect 
the rights and interests of the public 
and to ensure that human cell 
products for cell or gene therapy of cell as well as  gene therapy medicinal 
products to ensure that cell or gene 
therapy medicinal product s have no risk 
of infectious diseases.  
The R&D of cell and gene therapy 
medicinal products  can only be 
conducted after  the d onors have  been 
clearly informed of , and explained , the 
relevant rights and obligations with 
which such  R&D  are involved , with  
their full understanding  and a  written 
consent signed  by them . meet the safety requirements  and 
have no risk of infectious diseases.  
2. The central competent health 
authority is authorized to prescribe 
the method to judge the suitability 
of the donor . 
Article 5 ( Registration and market 
approval ) 
For the manufacturing and import 
of cell and gene  therapy medicinal 
product s, the source of active 
pharmaceutical ingredients, 
specifications, functions, summary of 
manufacturing process, and the 
specification and method of testing, as 
well as other related information and 
certificates, accompanied by la bels and 
use instructions in the original and 
Chinese languages, and samples, 
together with the fee paid, shall be filed 
with the central competent health 
authority for registration and market 
approval. No manufacturing or 
importation of such cell and gene  
therapy medicinal product  shall be 
allowed until a permit license is 
approved and issued.  
Only the owners of a cell and gene 
therapy medicinal product  permit license 
or their authorized persons may apply 1. It is clearly stipulated that no 
manufacturing or importation of 
such product  shall be allowed until 
it is filed with the central 
competent health authority for 
registration and market approval , 
and a  permit license is approved 
and issued.  Paragraph 1 of this Act 
is formulated referring  to Article 39 
of the Pharmaceutical Affairs Act 
when Item 1 of this article is made.  
2. In addition, t he central competent 
health authority is authorized to 
prescribe  the relevant review 
procedures for registration and 
market approval . for import of cell and gene therapy 
medicinal product s pursuant to the 
provisions of the preceding  Paragraph.   
A cell and gene therapy medicinal 
product  manufacturing or import permit 
license shall be valid for five (5) years. 
Where it is necessary to continue the 
manufacturing or importation of 
medic ament upon permit license 
expiration, the permit license may be 
extended with the prior approval of the 
central competent health authority 
provided that the term of each extension  
is limited to no more than five (5) years. 
The permit license shall be revok ed 
upon expiry of the term thereof  if the 
permit license holder fails to file an 
application for extension , or if the 
application for extension is disapproved.  
Article 6 (Temporary license subject to 
certain conditions or ti me) 
When cell and gene therapy 
medicinal products are presumed to 
possess  the efficacy mentioned in the 
relevant application and the safety is 
confirmed, after verif ication  by the 
central competent health authority, a 
temporary permit license subject to  
certain conditions can be issued, but the 
validity period of the  permit  license 
shall not exceed five years.  
The manufacturer s of cell and gene 
therapy medicinal products who have 
obtained the above -mentioned 
temporary permit license shall conduct 
applica tion effectiveness  tests in 1. The e fficacy validation has not yet 
been conducted  on part of the cell 
and gene therapy medicinal 
products, but there are sufficient 
data to presume  efficacy . To take 
into consideration the rights of 
people in the country  to use cell 
and gene therapy medicinal 
products as soon as possible, given 
that the safety  has been ensured , a 
temporary license subject to  certain 
conditions or time limit can be 
granted to differentiate from the 
permit license as prescribed  in 
Article 6  referring  to the provisions 
of Article 23 to Article 26 of 
Japan ’s Pharmaceuticals and accordance with the requirements  of the 
central competent health authority, 
report the results to the central 
competent health authority, and reapply 
for the permit license within the 
approved validity period.  Medical Device Act.  
2. When a temporary permit license of 
cell and gene therapy medicinal 
products is obtained in accordance 
with this Article , application 
effectiveness  tests of cell and gene 
therapy medicinal products shoul d 
continue to be conducted, and a 
reapplication for registration and 
market approval  should be made 
within the validity period ; if 
compl ying with the  provision of 
Article 6, the temporary permit 
licen se can be changed to the 
product permit license.   
Article 7 (Manufacturing standards for 
cell and gene therapy medicinal 
products)  
The manufactur e of cell and gene 
therapy medicinal products shall  comply 
with the good manufacturing practic es; 
the manufacture may only begin after 
the central competent health authority 
has completed its inspection and granted 
approval , and the medicament 
manufacture license has been obtained.  
The provisions of the preceding 
paragraph shall apply mutatis mutandis 
to overseas manufacturing factories 
importing cell and gene therapy 
medicinal products . To ensure the quality of cell and gene 
therapy medicinal products and prevent 
the occurrence, con tagion and spread of 
infectious diseases, the manufacturing 
factor ies of cell and gene therapy 
medicinal products should abide by the 
standards set by the central competent 
health authority . The central competent 
health authority is authorized to  
prescribe the standards for the factory’s 
related equipment. This Article is 
formulated referring  to Article 57 and 
Article 57 (1) of the Pharmaceutical 
Affairs Act. 
Article 8 ( Information  maintenance 
obligation of the firms of cell and gene 
therapy medic inal product s) 
The firms of  cell and gene therapy 
medicinal product s shall establish the 1. To safeguard the rights and interests 
of the public,  the central competent 
health authority shall specify  a 
certain period to monitor  the safety 
of cell and gene therapy medicinal Patient Registration  System to track 
patients who have been given the 
treatment  with cell and gene therapy 
medicinal products.  
The registration  system as referred 
to in the preceding paragraph shall 
continue to be effective within thirty 
years from  the day of the expiration or 
revocation of the cell and gene therapy 
medicinal product permit license.  products approved to be 
manufactured or imported. The 
Patient Registration  System should 
be establish ed with  the firms of cell 
and gene therapy medicinal 
product s to track patients who have 
been given the treatment  with cell 
and gene therapy medicinal 
products. This Article  is formulated 
to effectively monitor the 
post-marketing safety.  
2. The central competent health 
authority is authorized to prescribe 
the measures for the 
post-marketing safety monitoring 
on the  cell and gene therapy 
medicinal products . 
Article 9 (Advertisement management)  
Persons other than firms of cell and 
gene therapy me dicinal products  are not 
allowed to make advertisements for 
medicaments . 
Advertisement s of cell and gene 
therapy medicinal products shall be 
published in academic medical journals.  
Interviews, news reports or 
propaganda containing information 
implying or s uggesting medical efficacy 
shall be regarded as advertisements of 
cell or gene therapy medicinal products.  To safeguard the rights and interests of 
the public and avoid false information in 
advertisement s, the measures are thus 
formulated to impose restrictions on the 
advertisement s of cell and gene therapy 
medicinal products.  
Article 10 (Measures formulated 
separately)  
The suitability of donors  as referred 
to in Article 4 , registration and market 
approval  for a permit license of the  cell 
and gene therapy medicinal product  as The central competent health authority 
shall be authorized to prescribe  relevant 
measures to facilitate the 
implementation of practices.  referred to in  Paragraph 1 of Article 5, 
or change or transfer  of registration of 
cell and gene therapy medicinal 
products permit license  to be handled in 
accordance with the regulations , the 
application criteria , inspection procedure 
and relevant good manufacturing 
practice s as referred to in  Paragraph 1 
and 2  of Article 7, the Registration  
System  as referred to in  Article 8 and 
other matters to be complied with shall 
be prescribed  by the central competent 
health  authority. . 
Article 11 (Penal provisions)  
Any person who violates the  
provisions of Article 5 and Paragraph 1 
of Article 7 under this Act shall be 
subject to punishment with 
imprisonment for a period of not more 
than ten (10) years  and may in addition 
thereto, be imposed with a fine of not 
more than NT$100,000,000 . 
The offe nder set forth in the 
preceding Paragraph shall be punished 
with life imprisonment or imprisonment 
of not less than ten (10) years and may 
in addition thereto, be imposed with a 
fine of not more than NT$200,000,000 
in case the said offence results in 
perso nal death; or with imprisonment of 
not less than seven (7) years and may in 
addition thereto, be imposed with a fine 
of not more than NT$150,000,000 in 
case the offence results in serious 
adverse health consequences.  
    Any person who commits the Penal provisions of any violation of  the 
provisions under this Act  are explicitly 
formulated . offence set forth in the first Paragraph 
hereof by negligence shall be punished 
with imprisonment of not more than 
three (3) years, detention, or a fine of 
not more than NT$10,000,000.  An 
attempt of the offence set forth in the 
first Paragraph hereof shall be puni shed. 
Article 12 (Penal provisions)  
Any person who violates the 
provisions of Article 8 shall be imposed 
with a fine of not less than NT$30,000 
but not more than  NT$2,000,000 . 
A violator of the provision of 
Article 9 shall be issued a fine of not 
less than NT$2 00,000 but not more than 
NT$5,000,000 . Penal provisions of any violation of  the 
provisions under this Act  are explicitly 
formulated . 
Article 13 (Law enforc ement agency)  
The penalties  specified in this Act 
shall be imposed by the municipal or 
county (city) competent health authority , 
and by the central competent health 
authority  if necessary . 
In the event that the fines imposed  
under  this Act  are not paid within the 
time period specified, the case shall be 
transfer red for compulsory execution  
according to law.  Penal provisions executed by the 
competent authority(ies) are explicitly 
formulated.  
Article 14 (Enforcement rules)  
The Enforcement Rules of this Act 
shall be established by the central 
competent health authority.  It is made clear that the Enforcement 
Rule s of this Act shall be prescribed by 
the central competent health authority.  
Article 15 (Effective date)  
The Act shall become effective one 
year after the date of promulgation.  This 
Act becomes effective after one year 
from  the date of promulgation.  The response time is given to the r elated 
bodies including the competent 
authority for advocacy and preparation 
for the implementation  of the Act.