Drugs Manufacturing & Sale

The new regulations (after 25th Dec, 2014) can be summarized as follows.

To manufacture and sell drugs except in-vitro diagnostic medical devices, license for manufacturing and selling drugs is required.
License for manufacturing and selling drugs can be classified into two different types of class 1 and class 2.
1st Paragraph of Article 12 in law for drugs and medical devices
(License for manufacturing and selling)
Drug Type License Type Expiry Period
The drugs approved by MHLW (Ministry of Health, Labour and Welfare) as indicated in the 1st paragraph under article 49 of pharmaceutical affairs law.

Class 1

License for manufacturing and selling drugs

5 years
Drugs other than those indicated above (excluding prescription drugs)

Class 2

License for manufacturing and selling drugs

5 years
For manufacturing and selling drugs, a license is necessarily required for individual drug type in individual organization. For example, when selling both prescription drugs and quasi-drugs, you should be licensed for both class 1 and 2.
You should fulfill the following two conditions to be licensed for the manufacturing and selling.
  1. Standards for quality management
  2. Safety management (*Note) for manufacturing and selling
Regarding the resource condition, the qualifications of management administrator for manufacturing and selling, safety management administrator, and quality assurance administrator should be fully considered.
The safetymanagement upon manufacturing and selling indicates analyzing collected information regarding quality, validity, and safety, and then taking an appropriate action accordingly.
→ Please refer to the page of Medical Devices for details on in-vitro diagnostic drugs
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