Regulations for Registration of Medicinal Products Article 101
If a change in the formula of a Chinese medicine product involves changes of active ingredients, then the applicant shall re-apply for drug registration. However, the regulation shall not apply to cases of removing cinnabar or protected medical materials, cases based on standard formulas, or cases of proportional changes of other ingredients of a formula if applications for post-approval changes in excipients may be submitted in accordance with Paragraph 1 or 3 of the preceding article.
中文原文 藥品查驗登記審查準則第101條
中藥處方有效成分之變更，應重新申請查驗登記。
但刪除硃砂、保育類藥材，或依基準方處方或其他處方等比例變更者，準用前條第一項或第三項規定，以申請賦形劑變更登記之方式辦理者，不在此限。
但刪除硃砂、保育類藥材，或依基準方處方或其他處方等比例變更者，準用前條第一項或第三項規定，以申請賦形劑變更登記之方式辦理者，不在此限。