【正文】 The drug regulatory agency shall inspect a drug manufacturer as to its pliance with the GMP requirements and issue 3 a certificate to the manufacturer passing the inspection. ，藥品必須按照國家藥品標(biāo)準(zhǔn)和國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生 產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。 Drug manufacturers shall perform quality test of their products. 、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的，不得出廠。 With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for industry and merce. 《藥品經(jīng)營許可證》的，不得經(jīng)營藥品。(2) provided with the business operation premises, equipment, warehouses, and clear environment required for drug distribution。 The drug regulatory agency inspect a drug distributor as to its pliance with the GSP requirements, and issue a certificate to the distributor passing the inspection. ，必須建立并執(zhí)行進(jìn)貨檢查驗收制度，驗明藥品合格證明和其他標(biāo)識；不符合規(guī) 定要求的，不得購進(jìn)。 In the record shall be indicated the adopted name of drugs, dosage form, strength or size, batch number, date of expiry, manufacturer, purchaser (or seller), amount of the drug purchased (or sold), purchase or selling price, date of purchase (or sale) , and other items specified by the drug regulatory agency of the State Council. ，必須標(biāo)明產(chǎn)地。 Chinese crude drugs may be sold at fairs in urban and rural areas, except those otherwise specified by the State Council. 5 品，但持有《藥品經(jīng)營許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場設(shè)點出售中藥材以外的藥品。 The term of validation shall be noted in the Pharmaceutical Preparation Certificate for Medical Institution. For renewal of the certificate upon expiration, reviewing and approval again is required. ，應(yīng)當(dāng)是本單位臨床需要而市場上沒有供應(yīng)的品種，并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)后方可配制。 When a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council. 機(jī)構(gòu)必須分別執(zhí)行藥物非臨床研 究質(zhì)量管理規(guī)范、藥物臨床試驗質(zhì)量管理規(guī)范。 A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it. 71. 藥品必須符合國家藥品標(biāo)準(zhǔn)。 The drug regulatory agency of the State Council shall anize a pharmacopoeia mission, which shall be responsible for formulating and revising the National Drug Standards. 標(biāo)定國家藥品標(biāo)準(zhǔn)品、對照品。 The State adopts a protection system for certain traditional Chinese medicines. 度。 When major disasters, epidemic situations or other emergencies occur in the country, the department designated by the State Council may allocate drugs from the enterprises to meet the urgent need. 82. 禁止生產(chǎn)（包括配制）、銷售假藥。 （二）依照本法必須批準(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗而未經(jīng)檢驗即銷售的； It is produced or imported without approval, or marketed without being tested, as required by the Law。 （六 ）所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。 （二）不注明或者更改生產(chǎn)批號的； The batch number is not indicated or is altered。 or （六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。 Staff members of drug manufacturers, drug distributors and medical institutions who make a direct contact with drugs shall receive physical examination annually. ，不得從事直接接觸藥品的工作。 In the label or insert sheet shall be indicated the adopted name of the drug, its ingredients, strength, manufacturer, approval number, product batch number, production date, date of expiry, indications or functions, usage, dosage, contraindications, drug adverse reactions, and precautions. 、精神藥品、醫(yī)療用毒性藥品、放射性藥品、外用藥品和非處方藥的標(biāo)簽，必須印有規(guī)定的標(biāo)志。 Drug manufacturers, drug distributors or their agents are prohibited from offering, under any pretence, money or goods of value or other benefits to leading people, drug purchasers, physicians, or other related persons of the medical institutions where 9 their drugs are purchased. 、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品廣告批準(zhǔn)文號；未取得藥品廣告批準(zhǔn)文號的，不得發(fā)布。 No unscientific conclusion or guarantee on drug efficacy is permitted to be included in drug advertisement。 Drug regulatory agencies may conduct selective testing of drug quality in light of the need of supervision and inspection. ，并不得收取任何費用。 With regard to the drugs produced according to the provisions of this Law by drug manufacturers not located in the region, the local government and drug regulatory agency are not permitted to restrict or refuse their access to the region. 。 11 Drugs refer to the products that are used in the prevention, treatment and diagnosis of human diseases and intended for the regulation of the physiological functions of human beings, with specifications of indications, usage and dosage. They include Chinese crude drugs, prepared slices of Chinese crude drugs, traditional Chinese medicines, chemical drug substances (API) and their preparations, antibiotics, biochemical drugs, radioactive pharmaceuticals, serum, vaccines, blood products, and diagnostic agents. ，是指生產(chǎn)藥品和調(diào)配處方時所用的賦形劑和附加劑。 The drug regulatory agency of the State Council is responsible for supervision and administration of medical devices nationwide. 。 Class Ⅱ medical devices shall be inspected, approved and issued registration certificates by the drug regulatory agency of provinces, autonomous regions and municipalities directly of the Central Government. ，由國 務(wù)院藥品監(jiān)督管理部門審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊證書。 Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available. 器械的使用說明書、標(biāo)簽、包裝應(yīng)當(dāng)符合國家有關(guān)標(biāo)準(zhǔn)或者規(guī)定。 For the manufacturing of class Ⅱ and/or class Ⅲ medical devices, it requires inspection and approval by the drug regulatory agency of the provinces, autonomous regions and municipalities directly under the Central Government, who will then issue a Medical Device Manufacturing Enterprise License. 129.《醫(yī)療器械生產(chǎn)企業(yè)許可證》有效期 5年，有效期屆滿應(yīng)當(dāng)重新審查發(fā)證。 Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Man