This set of standards is formulated in accordance with regulations of Paragraph 5, Article 57 of the Pharmaceutical Affairs Act (hereafter referred as the Act).

The facility/premises/equipments and sanitary conditions of a medicament factory shall comply with this set of standards; matters not provided for herein shall be governed by other relevant laws and regulations.

When domestic medicament manufacturers of the new establishment, relocation, expansion, resumption of operations, or addition of new active pharmaceutical ingredients, dosage forms, processes (packaging and labeling), products, are in compliance with Part 2 of this set of standards and the Factory Management Guidance Act, the competent industry authorities of municipalities or counties (cities) shall issue them the factory registration documents, or approve their alterations of registration; the competent health authorities of municipalities or counties (cities) shall issue them the Pharmaceutical Business License, or approve their alterations of registration.
When domestic medicament manufacturers with the factory registration documents and Pharmaceutical Business License in accordance with the preceding Paragraph are found through inspection to be in compliance with Pharmaceutical Good Manufacturing Practice Regulations, regulated that manufacturers shall be issued the medicament manufacturing license for those items under good manufacturing practices for drug (medicinal products) or good manufacturing practices for medical devices by inspections by the central competent health authority.
When foreign medicament manufacturers are found through inspection to be in compliance with the Pharmaceutical Good Manufacturing Practice Regulations, said manufacturers shall be issued pharmaceutical GMP certificates or medical device GMP certificates of qualified items by inspections by the central competent health authority.