日本PMDA认证注册辅导关于外国认证的考虑要点

注1：关于外国认证的考虑要点（PTC）

准药物制造商

“申请人”由医生出具的医疗证明和个人简历

负责外国制造企业的人“不要

需要附上外国制造商认证申请表，

当相关的上市批准持有人负责地确保其可靠性时。

在这种情况下，“申请人”可以省略在部分中填写“地址”的空格“制造机构负责人”和“条件申请表上的“取消申请人资格”。

此外，“申请人”需要通过显示“符合GMP的准药品”或“不符合GMP的准药品”备注栏。

注2：关于外国认证的考虑要点（PTC）

医疗器械和体外诊断制造商

当“申请人”有合理和令人信服的理由难以从所在国的医生处获得医疗证明他们居住，他们可以提交书面的自我声明，而不是医疗证书。

(3) Application for Change/Addition in Category of Accreditation of Foreign 

Manufacturers

When an “Accredited Foreign Manufacturer” changes the category accredited to

their manufacturing establishment or adds new categories to their accreditation, 

they must submit a form, “Application for Change/Addition” (Form No. 21 specified in 

the PAL Enforcement Regulations), in order to newly obtain the Minister’s 

accreditation for the change or addition. 

When the manufacturer intends to add new categories to their accreditation, they 

need to apply for addition in accreditation category. 

On the other hand, applying for change in category of accreditation allows the 

manufacturer to be accredited to new categories while cancelling their previously 

accredited categories. 

In both of the cases, the manufacturer also needs to submit a form of “Application 

for Accreditation Examination” (Form No. 16-(2) in the Regulations) in the same way 

of a new application as referred to in 2-(1) above.