Partial amendments to the Order for Enforcement of the Pharmaceutical 
Affairs Act and other related orders, ordinances and public notices, as 
well as establishment of new ordinan ces and public notices related 
amendment od Pharmaceutical Affairs Act 
 
 
The amendments and establishments of or ders, ordinances and public notices 
related to enforcement of amendment for t he Pharmaceutical Affa irs Act will include 
following; I. Amendments of the Order for Enforcem ent of the Pharmaceutical Affairs Act 
II. Amendments of the Ministerial Ordinance for Enforcement of the Pharmaceutical 
Affairs Act 
III. Amendments of the Mini sterial Ordinance on Standards  for Manufacturing Control 
and Quality Control for Medical Devices and In-Vitro Diagnostics 
IV. Establishments of orders, ordinances and public notices related to Regenerative 
and Cellular Therapy Products and Gene Therapy Products 
 
Major Points on the amendments and establishments are as follows; 
I. Amendments of the Order for Enforcem ent of the Pharmaceutical Affairs Act 
1. New clauses on medical devices will be established separate from 
pharmaceuticals.  
2. New category on Software as a Medical Device will be added;  
・Diagnostic Software 
・Therapeutic Software  
・Preventive Software 
3. Software as a Medical Device with low risk (defined as Gener al Medical Device) 
will be exempted from the application of the amended Pharmaceutical Affairs Act. 
4. New category for Regenerative and Ce llular Therapy Produc ts and Gene Therapy 
Products will be added; 
・Human Cell -Processed Products 
・Animal Cell -Processed Products 
・Gene Therapy Products 
 
II. Amendments of the Ministerial Ordinance for Enforcement of the Pharmaceutical 
Affairs Law 
1. New clauses on medical devices will be established separate from 
pharmaceuticals. 
2. Procedures on the regist ration of medical device manufacturer will be defined. 3. Procedures on QMS inspection to a ma rketing authorization holder of medical 
devices will be defined. 
4. Procedures on license to a marketing authorization holder, a manufacturer for 
Regenerative and Cellular Therapy Pr oducts and Gene Therapy Products will be 
defined. 
5. The Conditions where a marketing author ization holder could omit a package 
insert of medical devic e will be defined following. 
① A package insert indicates obtaining way on its information through the 
internet. 
② A marketing authorization holder provi des a paper package insert promptly 
when medical profe ssionals request it. 
③ A marketing authorization holder provi des information to the users promptly 
when package are changed. 
④ Information of a package insert c an be obtained from t he webpage of PMDA. 
 
III. Amendments of the Ministerial Ordinanc e on Standards for Manufacturing Control 
and Quality Control for Medical Devices and In-Vitro Diagnostics  
1. To harmonize 2nd chapter  completely with ISO13485: 2003. 
2. To add ISO13485: 2003 such as confirma tion by a marketing authorization holder 
for a manufacturing site to comply the standards, storage peri od of documents and 
records, and to establish of reporting syst em for malfunction or  adverse event in 
3rd chapter. 
 
IV. Establishments of ordinances and public  notices related to Regenerative and 
Cellular Therapy Products and Gene Therapy Products 
1. Since Regenerative and Cellular Ther apy Products and Gene Therapy Products 
has been newly defined in the partial amendment of Pha rmaceutical Affairs Act, 
new ordinances and public notices are established like as those for medical 
devices as well as pharmaceutical s. These will include the following; 
 Ordinance on Good Clinical  Practice for Regenerat ive and Cellular Therapy 
Products and Gene Therapy Products 
 Ordinance on Good Laboratory Practi ce for Regenerative and Cellular 
Therapy Products and Gene Therapy Products 
 Ordinance on Good Postmarketing Survei llance Practice for Regenerative and 
Cellular Therapy Products and Gene Therapy Products and 
 Public Notice on designated Regenerat ive and Cellular Therapy Products and 
Gene Therapy Products.