Announcement of the Standing Committee of the Tenth People’s Congress of Jiangsu Province No.144 The Regulations of Jiangsu Province on Drug Supervision and Administration, adopted at the Thirty-Third Meeting of the Standing Committee of the Tenth People’s Congress of Jiangsu Province on November 30, 2007, are hereby promulgated and shall enter into effect as of May 1, 2008. November 30, 2007   Regulations of Jiangsu Province on Drug Supervision and Administration (Adopted at the Thirty-third Meeting of the Standing Committee of the Tenth People’s Congress of Jiangsu Province on November 30, 2007)     Chapter I General Provisions   Article 1 These Regulations are enacted in accordance with the Drug Control Law of the People’s Republic of China (hereinafter referred to as the Drug Control Law) and the Regulations for the Implementation of the Drug Control Law of the People’s Republic of China (hereinafter referred to as Regulations for the Implementation of the Drug Control Law ), in light of the specific situation of this Province, and for the purposes of tightening drug control and ensuring drug quality and safety for human beings.   Article 2 All units and individuals engaged in research, production (pharmaceutical preparations), distribution, use or control over drugs within the administrative region of this Province shall abide by these Regulations.   Article 3 The local people’s government at or above the country level shall incorporate the work of supervision and administration on drugs for safety control into the objectives for evaluation on government performance, strengthen the leadership and coordination on the work of supervision and administration on drugs within the administrative region of his Province, establish and improve the coordination mechanism for drug supervision and administration and the departmental responsibility system for supervision and administration, and urge or assist the relevant departments to perform their duties according to law.   Article 4 The drug regulatory department at or above the county level shall be responsible for the drug supervision and administration work within its administrative region.   The departments such as the public health, industrial and commercial administration, and pricing shall be responsible for the supervision and administration work related to drug control according to their respective functions and duties.     Chapter II  Control over Drug Research and Production   Article 5 Drug research shall be carried out in accordance with the provisions in the Good Non-Clinical Laboratory Practice (GLP) and the Good Clinical Practice (GCP).   The original record on drug research and the materials submitted for drug registration shall be truthful, complete and normative. The materials such as the experimental data may not be forged or fabricated.   Article 6 Drug manufacturers shall meet the requirements provided in the Drug Control Law and the Good Manufacturing Practice for Pharmaceutical Products (GMP).   The person in charge of the manufacturing department of a drug manufacturer may not be the same person in charge of the quality control department of the manufacturer.   The appointment or change of the persons in charge as mentioned in the preceding paragraph shall be reported to the provincial drug regulatory department for record within 30 days since the decision is made.   Article 7 Drug manufacturers shall conduct drug production according to the national drug standards, and the formula and the production processes submitted for registration; where it is necessary to change the formula or the production processes which may affect the drug quality, they shall submit the matter for approval in accordance with the relevant provisions.   The drug substances and excipients for the manufacture of pharmaceutical products and the immediate packaging materials or containers shall meet the requirements of the relevant State provisions.      Article 8 Drug manufacturers shall keep authentic and complete records on purchase, inspection and acceptance of drug substances and excipients, and the immediate packaging materials or containers, the records on inspection and sell of finished pharmaceutical products and the necessary records on inspection of the semi-finished products.   The records provided in the preceding paragraph shall be kept up to one year after the expiration date of the product or three years in case no expiration date is prescribed for the product.   Article 9 Drug manufacturers shall carry out comprehensive ex-work inspection on the drugs manufactured in accordance with the drug standards. No one may forge or falsify the original drug inspection records and the testing reports.   Article 10 A label shall be printed on or attached to the drug package together with an insert sheet, as required by the regulations of the State. Standard Chinese characters, which shall be clear and legible, shall be used on the label and the insert sheet sheet. The expiration date of the drug shall be clearly and plainly indicated on the inside and outside labels of the drug.   Article11 Manufacturers which process export drugs upon authorization from abroad within the administrative region of this Province shall acquire the Drug Manufacturing Certificate and the Good Manufacturing Practice for Pharmaceutical Products (GMP) certificate for the drugs processed upon authorization. The drug manufacturer shall report to the provincial drug regulatory department for record within 30 days since it signs the commissioned processing contract.   Chapter III  Control over Drug Distribution   Article 12 No one may engage in the distribution of drugs without the Drug Distribution Certificate.   Drug distributors shall conduct business in compliance with the operation mode and business operation scope specified in the Drug Distribution Certificate   No drug manufacturer or drug distributor may sell drugs in the places not approved by the drug regulatory department.   No individuals are allowed to purchase drugs for business operation, however the Chinese crude drugs which are allowed to be purchased by the State are exceptions.   Article13 Drug manufacturers shall not sell drugs processed upon authorization or drugs manufactured by the others.   Drug distributors shall not purchase or sell pharmaceutical preparations dispensed by medical institutions.   Article 14 Where a drug manufacturer or a distributor knows or should know that a person is engaged in drug manufacture or distribution business without the manufacture or distribution qualification, it shall not provide drugs to such person.   The drug manufacturer or distributor shall not provide convenience such as its qualification documents or bills to those who try to distribute drugs in the name of the drug manufacturer or distributor.   Article 15 When a drug manufacturer or a drug wholesaler sells the drugs, it shall issue a sales voucher, which shall indicate the name of the supplier, the names of the drugs, the name of the manufacturer, and the batch number, quantity and price of the drugs.   When a drug retailer sells the drugs, it shall issue a sales voucher, which shall indicate the names of the drugs, the name of the manufacturer, and the batch number, quantity and price of the drugs.   Article 16 The drug distributor shall be staffed with technical personnel who are specialized in the quality control of drugs.   When the licensed pharmacists or other legally qualified pharmaceutical technicians of a prescription drugs and Class A non-prescription drug retailer are on duty, they shall wear their name cards; when they are not on duty, they shall stop selling the prescription drugs or the Class A non-prescription drugs.   Chapter IVControl over Pharmaceuticals in Medical Institutions   Article17 A medical institution may, according to the relevant regulations of the State, set up pharmacy or medicine cabinet for legally certified medical subjects of diagnosis and treatment and within the scope of drugs that can be used. The internal medical departments of the institution may not set up medicine cabinet without authorization.   The pharmacy or medicine cabinet set up by the medical institution shall be well located, and possess equipments, storage facilities, hygienic environment and other facilities that can ensure safety for patients. The specific measures shall be formulated by the provincial drug regulatory department jointly with the provincial public health administrative department.   Article 18 The tools, packaging materials and containers and the working environment of the medical institution for dispensing drugs shall meet the requirements on hygiene and quality and safety control, and may not cause contamination to the drugs so as to affect the quality of the drugs.   Where a medical institution needs to tear the retail package when dispensing the drugs, it shall make a record for tearing of the package and keep the original retail packaging material and the insert sheet of the drugs until the drugs are sold out. On the package for the drugs that have been taken out from their original retail package shall be indicated information such as the name of the drug, specification, usage, dosage, manufacturing date and expiration date of the drug.   Article 19 The medical institution shall use the drugs on the strength of the prescriptions and may not sell drugs or sell drugs under disguise through such means as forging prescriptions, open-shelf sale, free diagnosis, charity sale, medical consultation, trial use or exhibition.   Article 20 The medical institution shall dispense pharmaceutical preparations in compliance with the prescriptions and production process submitted for registration, and can only put the pharmaceutical preparations into use after they are inspected according to the approved quality standards and prove to be qualified.   The drug substances and excipients for dispensing pharmaceutical prescriptions and the immediate packaging materials or containers used by the medical institution shall meet the requirements of the relevant State regulations.   Article 21 Where a medical institution authorizes other drug manufacturers or medical institutions to dispense pharmaceutical prescriptions for it, the matter shall be examined and approved by the provincial drug regulatory department in accordance with the regulations and procedures specified by the drug regulatory department under the State Council.   Chapter VControl over Drugs   Article 22 Drug manufacturers, drug distributors and medical institutions shall purchase drugs from pharmaceutical enterprises, which are qualified for production or distribution, rather than from the individuals or units which do not have the qualification for production or distribution. However, the purchase of Chinese crude drugs where no control by approval number is exercised will be an exception.   Article 23 The drug name on the insert sheets and the labels shall be in consistent with those in the approval documents of the drug. The name of a drug, including adopted name or commodity name, which are not approved by the drug regulatory department under the State Council shall not be used.   The provincial drug regulatory department shall order to stop selling or using within the administrative region of this Province the drugs labeled with a name not approved and shall make a public announcement. Drug manufacturers, distributors or medical institutions shall not sell or use such drugs.   Article 24 No drug manufacturer or distributor may introduce the indications and functions of a drug beyond the scope specified by the drug regulatory department under the State Council through such means as inserting advertising materials into the packaging of the drugs or attaching such materials to the drugs.   Article 25 It is forbidden to add pharmaceutical ingredients into non-drug products in violation of the relevant provisions of the State.   A non-drug product shall not be labeled with an adopted drug name, ant its illustration sheets, labels and packaging shall not involve any content concerning indications and functions.   Article 26 Where a drug manufacturer finds out that there is hidden danger in the drugs it produces, which may affect the health and life safety of human beings, it shall release relevant information to the public immediately, request the drug distributors and medical institutions to stop selling or using the drugs, ask the consumers to stop taking the drugs, recall the drugs voluntarily, and report the matter to the local drug regulatory department; the drug distributors and the medical institutions shall stop selling and using the drugs immediately.   Where a drug distributor or a medical institution finds out that there is hidden danger in the drugs it sells or uses, which may affect the health and life safety of human beings, it shall stop selling or using the drugs, notify the drug manufacturers or suppliers immediately, keep the drugs cautiously and report the matter to the local drug regulatory department.   Where the drug regulatory department finds out that there is hidden danger in the drugs, which may affect the health and life safety of human beings, it shall order the drug manufacturers to recall the drugs and the drug distributors and the medical institutions to stop selling or using the drugs and release relevant information to the public immediately.   Article 27 Family planning technical service institutions, blood-collecting and supplying institutions and units using drugs for prevention and control of disease or fighting against drug abuse shall abide by the provisions in the Drug Control Law, the Regulations for the Implementation of the Drug Control Law, and these Regulations on purchase, acceptance, storage and use of drugs by the medical institutions.   Chapter VI  Control over Drug Pricing and Advertising   Article 28 The State adopts government-fixed prices, government-guided prices, and prices adjustable with the market for drug pricing.   For drugs the prices of which are fixed or guided by the government, the competent pricing department shall fix and adjust their prices according to law based on the pricing catalogues of the State and the Province. For drugs the prices of which are adjustable with the market, the drug manufacturers and distributors shall decide the prices according to law and on their own. For drugs in medical institutions, the relevant provisions of the State shall be implemented for the pricing.   The competent pricing department shall regularly make public the drug prices which have been examined and approved, strengthen supervision and inspection on the drug prices and investigate into the law-breaking acts in pricing in time.   Article 29 Drug manufacturers and drug distributors shall strictly enforce the relevant provisions of the State on drug pricing and provide the truthful manufacturing and operating cost to the competent pricing department. Where drug manufacturers and drug distributors produce or sell drugs the prices of which are adjustable with the market, they shall not fix them at an excessively high price and shall strictly abide by the regulations on price increase percentage for drugs in circulation.   Drug manufacturers shall not raise drug prices under disguise through means such as changing the name, dosage form, specification and packaging of the drugs   Drug manufacturers, drug distributors and their agents are prohibited from raising drug prices for sale through offering rake-offs or other benefits in the course of drug distribution. . Usurious profits and fraud in pricing that harms the users’ interests are prohibited.   Article 30 This Province implements the basic drug system. The Provincial People’s Government shall formulate the basic drug catalog in compliance with the principle of being safe, effective, necessary and economic to ensure the basic drug supply to the people. The specific measures for the manufacturing, supply and use of basic drugs shall be formulated by the Provincial People’s Government separately.   Article 31 Drug advertisements issued by the drug manufacturers of this Province shall be subject to the approval of the provincial drug regulatory department, and an approval number of drug advertisement shall be issued; the drug manufacture which is going to launch advertisements within the administrative region of this Province shall, according to the relevant provisions of the State on examination of the drug advertisements, report to the drug regulatory department of this Province for record before launching the advertisements.   For drug advertisements that have been approved, the provincial drug regulatory department shall publicize the approval numbers and approval contents on the internet within three working days and send a copy to the provincial industrial and commercial administration department.     Article 32 The content of drug advertisements shall be truthful and lawful, and the insert sheet approved by the drug regulatory department under the State Council shall be taken as the basis, and no false content may be contained in them.   No unscientific, categorical assertion or warranty of described function may be contained in drug advertisements; no names or images of government departments, medical or pharmaceutical research institutions, academic institutions, or experts, scholars, physicians and patients may be used as evidence for drug advertising or propaganda in other forms.   The drug regulatory department shall set up a warning system against illegal drug advertisements, give warning to the public in time for the drugs of which the advertisements have been launched in violation of the law to a serious extent, and make known to the public in a timely manner the correct and scientific drug information.     The provincial drug regulatory department shall order to suspend the sale of the drugs within the administrative region of this Province the advertisements of which have been launched without being approved or reported for record, or the advertisements of which contain exaggerated indications, functions and therapeutic effects and may delude and seriously mislead the drug users, and shall make it known to the public.   Article 33 News media and other units which launch advertisements shall verify the approval documents for launch of the drug advertisement and shall not launch any drug advertisement which is not approved or contains false information.   Article 34 The industrial and commercial administration department shall strengthen monitor on drug advertisements, release monitor bulletin every month, make public announcement on illegal drug advertisements, investigate into the drug advertisements which violate the relevant provisions in the laws and regulations of the State, and feed back the investigation result to the drug regulatory department.   Chapter VIIInspection of Drugs   Article 35 The provincial drug regulatory department shall formulate the plan for selective testing of drug quality in light of the specific drug quality situation of this Province, establish a reasonable ratio for supervision-oriented selective testing and appraisal-oriented selective testing, and publicize the drug quality selective testing result on a regular basis.   The provincial drug regulatory department shall strengthen the construction of drug testing institution, ensuring that the drug testing institution is equipped with correspondent technical equipment and staffed with necessary technical personnel.     Article 36 Where the pharmaceutical preparations dispensed by a medical institution are suspectable of containing impurities and adulterants, and the testing methods and items for testing specified in the standards of the pharmaceutical preparations approved by the provincial drug regulatory department don’t work for the testing purpose, the drug testing institution may conduct testing on the pharmaceutical preparations with other alternative testing methods and may test on more items. The testing results so obtained, after being approved by the provincial drug regulatory department, may be used as the basis for certifying the quality of the pharmaceutical preparations by the drug regulatory department.    Article 37 The drug regulatory departments of a city divided into districts or a county (city, district) may employ drug regulatory assistants and information assistants from streets, communities, and towns (townships) to assist in the drug quality inspection.   Article 38 The provincial drug regulatory department shall be in charge of the monitor on adverse drug reactions and drug abuse within the administrative region of this Province.   The drug regulatory department shall establish a network for monitoring adverse drug reaction within its administrative region, and supervise and guide the adverse drug reaction monitoring work conducted by the drug manufacturers, distributors and the medical institutions.   The public health administrative department shall strengthen management on the adverse drug reaction monitoring work in the medical institutions.   Drug manufacturers, drug distributors and medical institutions shall employ full time or part-time personnel to conduct monitoring on adverse drug reaction, implement the system of report on adverse drug reaction of the State and submit the adverse drug reaction monitoring report to the drug regulatory department according to the provisions.   Article 39 The drug regulatory department shall promote the construction of a credit system to safeguard the safety and effectiveness of drug and conduct management by categories on the drug manufacturers and distributors according to the credit levels they represent. The enterprises with low credit level shall be subjected to close supervision.   Article 40 The drug regulatory department shall establish the system of complaint, report and investigation for drug supervision, publicizing the complaint hotline, mail address and email address, and encouraging units and individuals to conduct supervision on drug quality, order of drug market and drug administration. The drug regulatory department shall keep secret for reporters and reward those whose reports prove to be truthful according to the relevant provisions.   Chapter VIIILegal Liabilities   Article 41 Where any one of the following acts is committed, a disciplinary warning shall be rendered and an order for making correction within a prescribed period of time shall be given; where the correction fails to be made at the expiration of the time limit, a fine of not less than RMB2,000 yuan but not more than RMB10,000 yuan shall be imposed.   (1) in violation of the provisions in Article 16 of these Regulations, the drug distributor is not staffed with technical personnel who are specialized in the quality control of drugs or the drug retailer sells prescription drugs or Class A non-prescription drugs when its licensed pharmacists or other legally qualified pharmaceutical technicians are not on duty;   (2) in violation of the provisions in Article 17 of these Regulations, the pharmacy or medicine cabinet set up by a medical institution is not up to the requirements provided, or the internal medical department of a medical institution set up medicine cabinet without authorization;   (3) in violation of the provisions in Article 18 of these Regulations, the tools, packaging materials and containers and the working environment of the medical institution for dispensing drugs does not meet the requirements on hygiene and quality and safety control, or the retail package of drugs are not torn open in compliance with the requirements provided.    Article 42 Where any one of the following acts is committed, an order for correction shall be given, the illegal gains shall be confiscated and a fine not less than RMB20,000 yuan but not more than RMB50,000 yuan shall be imposed; where the circumstances are serious, the Drug Manufacturing Certificate or the Pharmaceutical Preparation Certificate for Medical Institutions may be revoked.     (1) in violation of the provisions in the fist paragraph of Article 7 of these Regulations, changing formula to manufacture drugs without approval;   (2) in violation of the provisions in Article 20 of these Regulations, the medical institution changes the prescription to dispense pharmaceutical preparations without approval, or uses substances, excipients, and immediate drug packaging materials or containers which are not up to the provisions of the State to dispense pharmaceutical preparations.   Article 43 Where any one of the following acts is committed, the illegal gains shall be confiscated, and a fine not less than two times, but not more than five times the value of the drugs manufactured or sold in violation of the law shall be imposed; the approval documents for drugs, if any, shall be withdrawn, and an order shall be given to suspend production or business operation for rectification; where the circumstances are serious, the Drug Manufacturing Certificate, the Drug Distribution Certificate or the Pharmaceutical Preparation Certificate for Medical Institutions shall be revoked; where a crime is constituted, the criminal liabilities shall be investigated according to law.   (1) in violation of the provisions in Article 9 of these Regulations, a drug manufacturer fails to carry out an comprehensive ex-work inspection on the drugs it  manufacturers in accordance with the drug standards or issues fake testing reports;     (2) in violation of the provisions in Article 21 of these Regulations, giving authorization or accepting authorization without approval to dispense pharmaceutical prescriptions;   (3) in violation of the provisions in the first paragraph of Article 23 of these Regulations, purchasing, distributing or using drugs which are labeled with an unapproved adopted name.   (4) in violation of the provisions in Article 24 of these Regulations, introducing the indications and functions of a drug beyond the scope specified by the drug regulatory department under the State Council through such means as inserting advertising materials into the packaging of the drugs or attaching such materials to the drugs.   Article 44 Where in violation of the provisions in Article 25 of these Regulations, pharmaceutical ingredients are added into non-drug products, or a non-drug product is labeled with an adopted drug name, ant its illustration sheets, labels and packaging involve contents concerning indications and functions of a drug, the illegal gains shall be confiscated, and a fine not less than two times but not more than five times the value of the drugs manufactured or sold in violation of the law shall be imposed; where a crime is constituted, the criminal liabilities shall be investigated according to law.   Article 45 Where any one of the following acts is committed, the drugs manufactured and sold in violation of the law and the illegal gains shall be confiscated and a fine not less than two times but not more than five times the value of the drugs manufactured or sold in violation of the law shall be imposed; where a crime is constituted, the criminal liabilities shall be investigated according to law.   (1) in violation of the provisions in Article 11 of these Regulations, processing export drugs upon authorization from abroad without the Drug Manufacturing Certificate and the Good Manufacturing Practice for Pharmaceutical Products (GMP) certificate;     (2) in violation of the provisions in Article 12 of these Regulations, a drug distributor change its operation mode or distributing drugs beyond its scope of business, a drug manufacturer or drug distributor sell drugs in the places unapproved by the drug regulatory department or an individual purchases drugs which are not the Chinese crude drugs allowed to be purchased by the State;   (3) in violation of the provisions in the first paragraph of Article 13 of these Regulations, a drug manufacturers sells drugs manufactured upon authorization or drugs produced by others;   (4) in violation of the provisions in the second paragraph of Article 13 of these Regulations, a drug distributor purchases or sells pharmaceutical preparations dispensed by a medical institution.   (5) in violation of the provisions in Article 19 of these Regulations, a medical institution sells drugs or sells drugs under disguise.     Article 46 Where a drug manufacturer or a distributor, in violation of the provisions in the first paragraph of Article 14 of these Regulations, provides drugs to a person when it knows or should know that the person is engaged in the drug manufacture or distribution business without the manufacture or distribution qualification, it shall be ordered to make correction, its illegal gains shall be confiscated, and a fine of not less than RMB20,000 yuan but not more than RMB50,000 yuan shall be imposed; where the circumstances are serious, a fine of not less than RMB50,000 yuan but not more than RMB500,000 yuan shall be imposed.   Where a drug manufacturer or a distributor, in violation of the provisions in the second paragraph of Article 14 of these Regulations, provides convenience to others so that they can engage in the drug business in the name of the drug manufacturer or distributor, its illegal gains shall be confiscated, and a fine not less than the amount but not more than 3 times the amount of the illegal gains shall be imposed; where there is no illegal gains, a fine of not less than RMB20,000 yuan but not more than RMB100,000 yuan shall be imposed; where the circumstances are serious, the Drug Manufacturing Certificate or the Drug Distribution Certificate of the drug manufacturer or distributer shall be revoked, or the approval documents for the drugs shall be withdrawn; where a crime is constituted, the criminal liabilities shall be investigated according to law.   Article 47 A drug manufacturer, a distributor or a medical institution which, in violation of the provisions in the second paragraph of Article 23 of these Regulations, still sells or uses the drugs that have been ordered not to sell or use shall be ordered to make correction, its illegal gains shall be confiscated, and a fine of not less than RMB20,000 yuan but not more than RMB100,000 yuan shall be imposed.   A drug manufacturer or a distributor which, in violation of the provisions in the fourth paragraph of Article 32 of these Regulations, still sells the drugs that have been ordered to suspend selling shall be ordered to make correction, its illegal gains shall be confiscated, and a fine of not less than RMB20,000 yuan but not more than RMB100,000 yuan shall be imposed.   Article 48 Where a drug manufacturer, a distributor or a medical institution fails to perform its duties provided in the first and second paragraph of Article 26 of these Regulations, the drug manufacturer shall be ordered to recall the drugs, the drug distributor and the medical institution shall be ordered to stop selling and using the drugs, a fine of three times the value of the drugs shall be imposed on the drug manufacturer, and a fine of not less than RMB10,000 yuan but not more than RMB50,000 yuan shall be imposed on the drug distributor or the medical institution; where serious consequence is caused, the Drug Manufacturing Certificate or the Drug Distribution Certificate shall be revoked.The drug manufacturer, distributor or the medical institution which, in violation of the provisions in the third paragraph of Article 26 of these Regulations, fails to recall the drugs or does not stop selling or using the drugs according to the requirements of the drug regulatory department shall be ordered to make correction, a fine of five times the value of the drugs shall be imposed on the drug manufacturer, and a fine of not less than RMB20,000 yuan but not more than RMB100,000 yuan shall be imposed on the drug distributor or the medical institution; where serious consequence is caused, the Drug Manufacturing Certificate or the Drug Distribution Certificate shall be revoked.   Article 49 A family planning technical service institution, a blood-collecting and supplying institution or a unit using drugs for prevention and control of disease or fighting against drug abuse which, in violation of the provisions in the Drug Control Law, the Regulations for the Implementation of the Drug Control Law, and these Regulations on purchase, acceptance, storage and use of drugs shall be penalized according to the categories and extent of the administrative penalties imposed on the medical institution for illegal acts.   Article 50 A drug manufacturer, a distributor or a drug user such as the medical institution which commits an act in violation of drug pricing control shall be investigated and dealt with by the competent pricing department according to law.   Article 51 Where any drug advertisement is launched without the approval of the provincial drug regulatory department or the content of the drug advertisement launched is not consistent with the content approved, the drug regulatory shall, once such a case is found, notify the commercial and industrial administration department to investigate into and deal with the case according to law, and the drug regulatory department which has issued the approval document and number for the advertisement shall withdraw the approval document and number, and shall reject any application for examination and approval of the advertisement for the drug in question within one year; the responsible drug distributor shall be given a disciplinary warning and ordered to make correction within a prescribed period of time by the drug regulatory department; where it fails to make the correction at the expiration of the time limit, it shall be ordered to suspend business operation for rectification; where the circumstances are serious, the Drug Distribution Certificate shall be revoked.   The industrial and commercial administration department shall make the administrative sanction decision according to law within the statutory time limit.   Article 52 A news agency which launches illegal drug advertisements shall be given administrative penalties according to the provisions in relevant laws and regulations, and the main person in charge and the other person directly in charge shall be given a disciplinary warning, recorded with a demerit or even be dismissed where any one of the following acts is committed:   (1) launching drug advertisements which are forbidden by the State, and refusing to make correction when it is ordered to do so;   (2) launching drug advertisements which are not approved or which contains false information, and refusing to make correction when it is ordered to do so.   Article 53 The administrative penalties provided in Article 41 through Article 49 of these Regulations shall be given by the drug regulatory department at or above the county level; revocation of the Drug Manufacturing Certificate, Drug Distribution Certificate or Pharmaceutical Preparation Certificate for Medical Institutions shall be determined by the original department that has issued the certificate.   Article 54 The staff member of the drug regulatory department or other relevant department who commits any one of the following acts shall be given administrative sanctions according to law; where a crime is constituted, the criminal liabilities shall be investigated according to law.   (1) extorting or accepting money or things of value from others or seeking other benefits when conducting administration activities such as handling administrative license or carrying out supervision and inspection;   (2) failing to perform his statutory functions and duties according to law;     (3) participating in drug manufacturing or distribution activities;   (4) other acts provided by laws and regulations.     Chapter Ⅸ  Supplementary Provision   Article 55 These Regulations shall enter into effect as of May 1, 2008.