The Procedure for Manufacturing Drugs in Mie Prefecture, Japan.
The following details the necessary procedure for the commencement of manufacture (or importing) of drugs in
Mie Prefecture, Japan.
Note: The procedures described below are applicable in Mie Prefecture, Japan, as of April 2002. Due to future amendments and the disparities of laws in different prefectures, it is necessary to be informed as to the correct application procedures directly by the relevant prefecture.
1. For Manufacture (or Importing) of Drugs
Approval for the manufacture (importing) of each item, and a manufacturing (importing) license are required for the manufacture (or importing) of drugs.
|Drug Manufacture||Approval||The quality, effectiveness and safety of the drug under application must pass the examination. However, drugs listed on the Pharmacopoeia of Japan do not require approval.|
|License||The structural conditions (building and facilities) and human resource requirements (e.g. Administrators) of the drug manufacturing facilities must pass the examination to acquire a business license.|
2. Standard Period for the Administrative Process
There is a standard period for the administrative process of the approval and licensing examinations. Unless there are irregularities in the application or supplied data, the examinations are generally completed within the time specified.
|*Approval||Ethical Drugs||(new drugs)||1 year|
|(branded generic drugs)||1 year|
|Non-prescription drugs||10 months|
|IVD (in vitro diagnostic)||6 months
(approval for modification of storage conditions and period of effectiveness: 3 months)
|*Mie Prefectural License
(for manufacture or importing)
|Drugs, quasi-drugs, cosmetics, or new medical devices||56 days|
(1) The above periods for approval and licensing are applicable only in Mie Prefecture. Be aware that the standard periods for the administration process may differ in other prefectures. Further, the above period may be extended where a replacement of the application documents is required.
(2) Please feel free to contact us if you have any further questions.
3. Drug Approval Inspection
Apart from those drugs which do not require approval, most drugs are approved by the Minister of Health,
Labor and Welfare, and some are approved by the Governor. However, approval and receipt of applications based on both national and prefectural standards will occur at the prefectural government. The drug approval process is
Quasi-drugs, and medical devices are approved under the same process as drugs. As for cosmetics, those which contain ingredients that are not displayed, require approval.
4. License for Drug Manufacture (or Importing)
Below is a flowchart illustrating the license application process in Mie Prefecture. Applications are accepted by the Mie Prefectural Government.
At present, provided that there are no problems found at the site inspection, licensing will take 2 weeks. If you require licensing within 2 weeks due to your production schedule, with advance notice, we may give you
special consideration and shorten the duration of the licensing process.
The license is valid for 5 years, and must be renewed after 5 years. In addition, the application process for the business license for manufacturers (and importers) of quasi-drugs, cosmetics, and medical devices is the same as for a drug manufacturer (or importer).