According to Regulations for Registration of Medicinal Products, Article 9-4, specifications and test methods should be provided for coloring agents. However, if the coloring agents are components of hard capsules, are the specifications and test methods for the coloring agents still required in the drug product application?

刊登日期:2019-11-22  |  點閱次數 : 1171 次 

Yes, the information should be provided. If hard capsules are manufactured domestically, the specifications, test methods and certificates of analysis should be enclosed in the dossier for a domestic drug license application because domestic hard capsules are governed as drug products. For drug products which use domestic hard capsules, domestic drug license for the hard capsules can be provided as relevant information. If imported drug products contain foreign-manufactured hard capsules in its formulation, the applicants can declare that those hard capsules conform to the pharmacopoeias or the regulations of the ten advanced countries or European Union (e.g., US 21 CFR part 82, EU commission Regulation No 231/2012, EU Commission Directive 95/45/EC, Japan “医薬品等に使用することができるタール色素を定める省令”), or they can provide the specifications, test methods and certificates of analysis for the coloring agents used in the manufacture of the hard capsules based on the regulation for the excipients (auxiliary materials) as described in Regulations for Registration of Medicinal Products.



上一筆 Nitrogen filled in injections does not react with drug product and is not absorbe
下一筆 Regarding an acceptance criterion of "water content" specified for drug product,