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What is manufacturing?

Under the PMD Act, “manufacturing” includes not only the actual manufacturing of the product, but also the packaging, labeling, and storage of the products. To carry out these manufacturing activities, a manufacturing license must be obtained. There are various requirements for obtaining a manufacturing.
One thing to note is that as any manufacturer cannot ship a “product” to the market on its own; the product must be shipped to the market through a marketing holder.

JCIA’s voluntary GMP standards

Since quasi-drugs and cosmetics, which are not subject to Good Manufacturing Practice (GMP) regulations, are thereby not subject to GMP ministerial ordinances, JCIA has established a set of voluntary standards “Technical Guidelines for Cosmetics Manufacturing and Quality Control” in 1981 and had been asking member companies to comply with the standards. Later in 2007, International Organization for Standardization (ISO) established Good Manufacturing Practices (GMP) for cosmetic products, and JCIA completely revised the voluntary standards to ensure international consistence. Now we ask member companies to adopt and comply with ISO 22716.

License criteria (structure/equipment and technical supervisor)

Under the PMD Act, unless obtaining a license to manufacture quasi-drugs or cosmetics, no party can manufacture quasi-drugs or cosmetics as a business. The authorization requires that the structure and equipment meet the standards stipulated by the MHLW Ordinance in order to ensure that manufacturing is carried out without health and hygiene hazards. In addition, in accordance with the MHLW Ordinance, a responsible engineer must be assigned to each factory to manage manufacturing on site.

Agreement with marketing holders

For quasi-drugs and cosmetics, which are not subject to GMP, there is no legal requirement to conclude an “agreement” with a marketing holder described in Article 7 of the GQP Ministerial Ordinance. However, conclusion of an agreement is recommended by government. Such agreements may include (1) scope of manufacturing, (2) methods of manufacturing management and quality control, (3) shipping procedures, and (4) change control method. (Please refer to GQP Ministerial Ordinance)