Regulations of Medicament Manufacturer Inspection Article 9

The follow-up inspections of foreign pharmaceutical manufacturers of imported drugs shall be conducted every two years and may extend one to two years depending on the management system and standards for pharmaceutical manufacturing in country of origin; in addition to document review, on-site inspections shall be conducted depending on types of dosage forms of imported products, process activities, inspection history and the management system and standards for pharmaceutical manufacturing in country of origin. The foreign medical device manufacturers of imported medical device shall be inspected every three years.Manufacturers must apply for inspections mentioned in the preceding Paragraph six months prior to the expiration of their approval documents.When the central competent health authority deems it necessary, or finds that a medicament poses a major hazard, additional for-cause inspections may be conducted.Of the inspections mentioned in Paragraph 1 and 3, the central competent health authority inspects the current status of pharmaceutical GMP or medical device GMP implementation by manufacturers. Manufacturers shall cooperate with the inspection in accordance with regulations of Article 5 or Article 7.