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This application is a service of the Singapore Government.

Health Sciences Authority

Regulatory Framework 管理架构

Definition

“Chinese proprietary medicine” means any medicinal product used in the system of therapeutics according to the traditional Chinese method, that is to say, any medicinal product ––

(a) which has been manufactured into a finished product; 

(b) which contains one or more active substances derived wholly from any plant, animal or mineral, or any combination thereof; and

(c) which is, or all of its active substances of which are, described in the current edition of “A Dictionary of Chinese Pharmacy” or “The Chinese Herbal Medicine Materia Medica”, but shall not include ––

(i)  any medicinal product to be injected into the human body; or

(ii) any medicinal product which contains as an active substance any chemically-defined isolated constituent of any plant, animal or mineral, or any combination thereof.

定义

中成药是指任何用于传统中医治疗的药品,此药品必须:

(a) 已经被制成成品

(b) 包含一种或多种完全来源于植物、动物、矿物,或其组合的活性成份

(c) 这些活性成份要求记载于现今版的《中药大辞典》或《本草纲目》中,但是不包括:

(i) 任何用于人体注射的药品

(ii) 任何以从植物、动物或矿物中分离出的化学物质为有效成份的药品。

Under the Medicines (Prohibition of Sale and Supply) (Amendment) Order 2012, no person shall import, or sell or supply to any person, any Chinese proprietary medicine which contains any item specified in the Poisons List in the Schedule to the Poisons Act (Cap. 234), unless that item ––

(a) is a substance specified in the first column of the Second Schedule and satisfies the limit or condition in the second column of that Schedule; and

(b) is present naturally in the ingredients of the Chinese proprietary medicine.

SECOND SCHEDULE

First column Second column
Substance Limit or condition allowed
1. Boric acid; sodium borate Not more than 5% boric acid or 5% sodium borate or 5% of a combination of both
2. Ephedra, alkaloids of < 1%
3. Lobelia, alkaloids of < 0.1%
4. Lovastatin < 1%
5. Pomegranate, alkaloids of As pomegranate bark only
6. Berberine; its quarternary compounds; their salts No limit

根据2012年《药物决议》(禁止销售及供应)(修正案),任何人不得进口、销售或供应成份中含有《毒药法令》(第234章)中列明的物质的中成药,除了––

(a) 下表清单中第一项所列出的物质满足第二项中的限量,并且

(b) 所含成份是天然存在于中成药中的。

清单:

第一项 第二项
物质 允许的限量
1.硼酸及其盐 所含硼酸,或者硼酸盐,或者硼酸及其 盐不得超过5%
2.麻黄碱 < 1%
3.半边莲碱 < 0.1%
4.洛伐他汀 < 1%
5.石榴皮生物碱类 仅限石榴树皮
6.小檗碱,以及其季胺化合物,和小檗碱的盐类 没有限制

Having recognised the role of traditional Chinese medicine in the local context, HSA has taken steps to regulate products and practices in this area. HSA's Chinese Proprietary Medicines (CPM) Unit was set up in 1996 to administer regulatory control on CPM, with the following aims:

  • To ensure that CPM sold in Singapore are safe and of good quality;
  • To ensure that CPM are labelled appropriately; and
  • To facilitate prompt withdrawal of CPM from the market when necessary.

鉴于中药作为辅助药物在本地保健体系中所处的地位,卫生科学局已采取步骤对中药的产品和经营进行管理。中成药处于1996年成立,负责本地中成药的管理。管理的目的是要确保:

  • 在新加坡上市的中成药的安全和品质
  • 中成药的标签符合要求
  • 在必要时可迅速地将药品从市场上回收。

CPM dealers are required to apply for product listing of individual CPM which they intend to import or manufacture, provide information during the submission, and are only allowed to deal in listed products. Generally, CPM dealers must ensure compliance with the following requirements:

经营中成药的商家在进口或制造中成药产品之前,须申请中成药产品登记批准,并提供相关文件,只有被登记的产品方可在本地经销。一般上,经营中成药的商家须确保符合以下要求:

  • The CPM must not contain:
    • Any synthetic drugs;
    • Amygdalin, pangamic acid or its salts, danthron, suprofen or its salts and rhodamine B;
    • Any other substances except those stated on the labels;
  • The CPM must not exceed the limits set for:
    • Toxic heavy metals - Arsenic (5ppm), Copper (150ppm), Lead (20ppm) and Mercury (0.5ppm);
    • Microbial contamination; 
  • The CPM must meet labelling requirements and the labels and packaging materials must not stipulate any of the 19 diseases/conditions specified in the First Schedule of the Medicines Act. Examples are cancer, diabetes, hypertension and sexual function, etc. 
  • If the CPM contains substances listed under the Endangered Species (Import & Export) Act , dealers should contact:

    CITES Section
    Wildlife Regulatory Branch
    Agri-Food & Veterinary Authority (Headquarters)
    JEM Office Tower, 52 Jurong Gateway Road
    #14-01
    Singapore 608550
    Tel:  (65) 6227 0670
    Fax: (65) 6325 7646
  • 中成药不得含有:
    • 任何活性合成物质;
    • 苦杏仁苷、 潘氨酸及其盐、丹酮、舒洛酚及其盐、若丹明B;
    • 任何未在产品标签或产品成份表中所列出的成份。
  • 中成药不可超过以下限量:
    • 有毒重金属 -
      砷 (5ppm)、铜(150ppm)、铅(20ppm)、汞 (0.5ppm);
    • 卫生物限量。
  • 中成药的标签及包装上不得标示《药物法令》所列明的19种疾病/症状,如癌症、糖尿病、高血压、性功能等。 
  • 若中成药所含的成份属于《濒危物种(进出口)法令》下所列的品种,经营商须先向新加坡农粮与兽医局询问:

      CITES Section
      Wildlife Regulatory Branch
      Agri-Food & Veterinary Authority (Headquarters)
      JEM Office Tower, 52 Jurong Gateway Road
      #14-01
      Singapore 608550
      电话: (65) 6227 0670
      传真: (65) 6325 7646

Importers must submit documents showing absence of western drugs, and test results of toxic heavy metals and microbial contents for every consignment of CPM imported.

中成药进口商必须在每批中成药产品进口时,呈交书面证明保证产品不含有西药,以及有毒重金属和卫生学检验报告。

For the advertising and sales promotion of CPM, dealers are required to obtain permit from the Health Sciences Authority.

中成药经销商若要对中成药产品进行广告和促销,须获得卫生科学局的准证,方可进行。