2nd Report of the Market Access Ombudsman Council (March 14, 1995)

2-(3) Simplification of approval and licensing procedures for proprietary drugs

1. Complainant: American Chamber of Commerce in Japan

2. Ministry concerned: Ministry of Health and Welfare

3. Complaint:

The Pharmaceutical Affairs Law stipulates that the manufacturing or import of drugs shall generally require approval to manufacture (import) and license to manufacture (import) each product.

Approval standards for proprietary drugs, which can be bought at pharmacies without a doctor's prescription, are drawn up by drug classes, for cold remedies, pain killers and anti-pyretics and so on, and the authority to approve products within the approval standards is delegated to prefectural governors.

The standard clerical processing period for proprietary drugs is 10 months, which is shorter than that for prescription drugs (18 or 24 months). Since examination of products meeting approval standards can be standardized, the clerical processing period is even shorter.

The following complaint was made: In Japan, excessive time is required for procedures, since even those proprietary drugs which meet approval standards must gain approval and license as drugs, and therefore the competent authorities should study adopting a reporting system like that in use in the United States or a similar system.

4. Results of deliberation:

According to the ministry concerned, approval standards for proprietary drugs are general guidelines of examination to secure its transparency, and approval examination of ingredients, quantity, efficacy, and specifications, etc. must be carried out for each product to in order to ensure its quality efficacy and safety.

However, because foreign businesses have complained that application procedures to receive approval and license as drugs take time, in order to improve market access in this area, approval and license procedures need to be simplified as much as possible, with thorough reference to systems in various countries, to reduce the clerical burden on applicants, and the time required for approval and license need to be shortened as much as possible.

The ministry concerned will streamline the documentation required for approval applications and will simplify and speed up procedures for approval and permission as follows during the current fiscal year and during FY1995.

(Measures to be taken in FY1994)
* Introduction of the division licensing system
Under this system, approval and license for each product will no longer be required if delegated manufacturers have a division license for corresponding manufacturing process
* Promotion of standardization of ingredient specifications, etc.
Standardized specifications for ingredients contained in drugs will be set out and successively incorporated into specification manuals, to make it possible to simplify the documentation needed for approval applications. For ingredients whose standardization is included in the specification manuals, approval application for partial change will no longer be required if the changes are made within the standardization specifications for the ingredient in question.

(Measures to be taken in FY1995)
* For drugs belonging to any of the pharmacotherapeutic categories whose approval standards are prepared, approval authority will be delegated to the prefectural governors.
Approval standards for external hemorrhoid preparations will be set out in FY1995
* Authority to license manufacturing and import will be delegated to the prefectural governors.
Authority will be delegated, except for manufacturing of vaccine etc.
* An application examination system by floppy disk will be introduced
* Standardization of ingredient specifications will be promoted

The government should make efforts to bring time and costs needed for approval and licensing procedures to a level similar to that of other countries by promoting the above measures.

Government decision (March 28, 1995)

2-(3) Simplification of approval and licensing procedures for proprietary drugs

With due reference to systems in various countries, approval and licensing procedures for manufacture and import will be simplified and speeded up as much as possible. The following measures will be taken in FY1995.

* New approval standards will be set for external hemorrhoid preparations, and the approval authority will be delegated to the governors.

* With the exception of manufacturing of vaccine, etc., the authority to grant licenses for manufacture and import/sale will be delegated to the prefectural governors.

* An application and examination system using floppy disks will be introduced.

* Standardization of ingredient specification will be promoted to simplify forms required for approval.

Follow-up (May 27,1996)

2-(3) Simplification of approval and licensing procedures for proprietary drugs

3) Approval standards for external hemorrhoid preparations have been established, and a notice from the Ministry of Health and Welfare delegated approval authority to the prefectural governors, in April 1995.
4) A revision to execution orders of the Pharmaceutical Affairs Law was made, delegating authority to license manufacturing and import (except for the manufacture of vaccines, etc.) to the prefectural governors.
5) A notice from the Director of the Examination Division, Pharmaceutical Affairs Bureau issued in June 1995 announced the start of a system for accepting applications for approval on floppy disks.
6) Proposed amendments of about 100 specifications for the Japanese Pharmacopoeia, and about 130 specifications for drug additives are being studied. When the proposed amendments have been compiled, they will be approved after examination in a study group.