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 which has been manufactured into a finished product and contains one or more active substances, all of which are derived wholly from plants, animals or minerals or a combination of any one or more of them, and the medicinal product or all of its active substances are described in the current edition of “A Dictionary of Chinese Pharmacy”, “The Chinese Herbal Medicine Materia Medica”  or such other publication as may be approved by the Minister, but shall not include –

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

(b)  any item specified in the Poisons List in the Schedule to the Poisons Act (Cap. 234); or

(c)  any medicinal product which contains as an active substance any chemically defined isolated constituents of plants, animals or minerals or a combination of any one or more of them.

定义

中成药是指任何用于传统中医治疗的药品,即任何含有一种或多种完全源自植物、动物或矿物的有效成份的药物制成品,而该药品或其全部有效成份均收录在现今版的«中药大辞典»,«本草纲目»或其他获部长批准之出版物内。中成药不包括:

(a)任何用于人体注射的药品

(b)何在«毒药法令»(第234章)中被列入毒药名单的药品; 或者

(c)任何以从植物、动物或矿物分离出的化学物质为有效成份的药品。

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 list individual CPM which they intend to import or manufacture, provide information during the submission, and are only allowed to deal in approved 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，须申请中成药产品批准，并提供相关文件，只有被批准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 substances listed under the Schedule to the Poisons Act；
  • 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
  5 Maxwell Road #02-00
  Tower Block MND Complex
  Singapore 069110
  Tel:  6227 0670
  Fax: 6325 7646

·  中成药不得含有：

o 任何在《毒药法令》中列有的成份；

o 任何活性合成物质；

o 苦杏仁苷、 潘氨酸及其盐、丹酮、舒洛酚及其盐、若丹明B；

o 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：

o 有毒重金属 -

砷 (5ppm)、铜 (150ppm)、铅 (20ppm) 、汞 (0.5ppm)；

o 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

5 Maxwell Road #02-00

Tower Block MND Complex

Singapore 069110

电话: 6227 0670

传真: 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。