Regulations for Registration of Medicinal Products Article 24-1

Except for radiopharmaceutical drugs, cell-based preparations and biopharmaceutical drugs needed to be tested by registration, the applicants should provide samples of new chemical entities, new compound medicine and the first active pharmaceutical ingredient to the central health competent authority for future inspection prior to be on the market.If the above-mentioned new chemical entities and new compound medicine are applied for a change in the dosage form of Article 52, a change in the formula of Article 53, a change in the excipient of article 56, a change in product appearance of Article 57, a change in the site relocation or the place of production of Article 62 Paragraph 1 Item 2, a change in the pharmaceutical toll-manufacturing of Article 64, and self-manufacturing retrieval after outsourced of Article 65, the applicants should also follow the preceding paragraph.