Japan Updates the Positive List of Accredited Foreign Quasi Drug Manufacturers

On Dec. 12, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued the appended list of “Accredited Foreign Manufacturers”, which is a list of all foreign manufacturers that have been accredited in Japan and includes 264 enterprises for quasi drugs (download the full list of accredited quasi-drug manufacturers here).
Note: The record marked in yellow refer to those enterprises that haven’t apply for renewal beyond (or within 6 months before) the expiry date.

Accreditation of Foreign Quasi-drug Manufacturers

A foreign manufacturer who intends to export quasi drugs that were produced in overseas countries to Japan is subject to the mandatory accreditation requirements specified by Minister of Health, Labour, and Welfare (MHLW).

The validity period of accredited foreign manufacturers is 5 years and requests to renew accreditation every five years.

Accreditation Categories

Generally these are three categories for the accreditation of quasi drug manufacturers:

1. Accreditation for all or part of the manufacturing process of sterile quasi drugs.

2. Accreditation for all or part of the manufacturing process of general quasi drugs (quasi drugs other than those indicated in the preceding item).

3. Accreditation for only the process of packaging, labeling or storage among the manufacturing processes of quasi drug.

Required documents

• A medical certificate for an Applicant from a physician;

• A curriculum vitae for the responsible person at the manufacturing establishment;

• “List of products” to be manufactured for exporting to Japan and “Documents on the manufacturing process”;

• Documents on the buildings and facilities of the manufacturing establishment;

• Copies of licenses or certificates pertaining to manufacturing license or marketing approvals obtained in original country.

Examination Fees