Laws & Regulations/
Drug Registration Regulation

(SFDA Order No. 28)


Chapter I

General Provisions

Article 1 The Provisions are formulated for the purposes of ensuring the safety, efficacy and quality of drugs and regulating drug registration in accordance with the Drug Administration Law of the People's Republic of China (herein after referred to as the Drug Administration Law), Administrative Permission Law of the People's Republic of China(herein after referred to as Administrative Permission Law) and the Regulationsfor Implementation of the Drug Administration Law of the People's Republic ofChina (herein after referred to as the Regulations for Implementation of the Drug Administration Law).

Article 2 The Provisions apply to theapplications for drug clinical trial, drug production or import, and conductingdrug approval, relevant testing for drug registration, or regulation thereof,within the territory of the People's Republic of China.

Article 3 Drug registration refers to theprocess of review and approval on which the State Food and Drug Administration,in accordance with the official procedures, evaluates the safety, efficacy andquality of the drugs applied for marketing, and decides whether or not toapprove such an application.

Article 4 The State encourages the research anddevelopment of new drugs and adopts the special review and approval withrespect to innovative drugs, new drugs for serious and life-threateningdiseases and to address unmet medical needs and drugs.

Article 5 The State Food and Drug Administrationis in charge of drug registration nationwide, and responsible for reviewing andapproving the clinical trial, production and importation of drugs.

Article 6 The drug registration shall follow theprinciples of openness, fairness and justice.

The State Food and Drug Administration adopts the system ofcollective responsibility of the chief reviewers, the system of publicizing andchallenging relevant persons, and the system of responsibility tracing, withsocial supervision in such procedures as acceptance, inspection, review andapproval and sending.

Article 7 In the process of drug registration,the drug regulatory department shall make known to the general public, and holdhearings on, the matters which it deems of vital importance and involvingpublic interests for the granting of permission.

Prior to making the decision of administrative licensing thathas a direct bearing on the vital interest between the applicant and the otherparty, the drug regulatory department shall inform the applicant and theinterested party of their rights of requesting for hearings, making statementsand argues.

Article 8 The drug regulatory department shallprovide the applicant with access to information on the status of the acceptance,examination, inspection, review and approval of drug registration applicationand the final resolution.

The drug regulatory department shall publicize the followinginformation on its official websites or at the official premises for acceptingapplications:

(1) the items, procedures, fees and their basis, and timelinesof the drug registration, index of all the data needed to be submitted andmodel text of the application form;
(2) the name list and other relevant information on the persons involved in theacceptance, examination, inspection, review and approval of drug registration;and
(3) general information about categories of approved drugs, etc.

Article 9 The drug regulatory department,relevant institutions and persons involved in the drug registration have anobligation to keep the technical secrets and trial data submitted by theapplicant confidential.

Chapter II
Application for Drug Registration

Article 10 An applicant for drug registration(hereinafter referred to as applicant) refers to the institution that submits adrug registration application and assumes corresponding legal liability.

A domestic applicant shall be an institution legally registeredwithin the territory of People's Republic of China that independently assumescivil liability and an overseas applicant shall be a legal overseas drugmanufacturer. Where an overseas applicant applies for import drug registration,it shall be done by its branch or entrusted agency within the territory ofPeople's Republic of China.

The persons who handle the application for drug registrationshall have professional knowledge and be familiar with the laws and regulationson, and the technical requirements for, drug registration.

Article 11 Drug registration applications includeapplications for new drugs, generic drugs, import drugs and their supplementaryapplications as well as re-registration applications.

Applications of domestic applicants shall be handled accordingto the procedures and requirements for new drugs or generic drugs, whereasapplications of overseas applicants shall be handled according to those forimport drugs.

Article 12 Application for new drugs refers toapplication for registration of drugs that have not been marketed within theterritory of People's Republic of China.

Application for changing dosage form or route ofadministration, or claiming a new indication for marketed drugs, shall besubmitted as the process of new drug application.

Application for generic drugs refers to registrationapplication for producing the drugs having existing national drug standardwhich is approved to be marketed by the State Food and Drug Administration,whereas the application for biological products shall be submitted as theprocess of new drug application.

Application for import drugs refers to registration applicationfor drugs manufactured abroad to be marketed within the territory of thePeople's Republic of China.

Supplementary application refers to application for variation,addition, or cancellation of the items or contents approved in the originalapplication for new drug, generic drug or import drug.

Re-registration application refers to application for continuedproduction or importation of a drug after the expiration of the valid term ofthe drug approval document.

Article 13 The applicant shall provide sufficientand reliable research data to prove the safety, efficacy and quality of thedrug, and be liable for the authenticity of all the dossiers submitted.

Article 14 The cited literature of the dossier ofdrug registration shall indicate the title of works or the name, volume number,issue and page of the journal. Where the cited references are not published, anauthor's permission shall be provided. For foreign literatures, Chinesetranslation shall be provided as required.

Article 15 The State Food and Drug Administrationshall obey the development plan and policies on the pharmaceutical industryconstituted by the State, and may conduct assessment to the market value ofdrugs.

Article 16 In the process of drug registration,the drug regulatory department shall conduct on-site inspection and causalinspection to the non-clinical studies and clinical trials, as well asproduction site inspection for the pre-marketing approval to confirm theauthenticity, precision and integrity of the dossier submitted.

Article 17 Where two or more institutions jointlyapply for drugs, the application shall be submitted to the drug regulatorydepartment of the province, autonomous region, or municipality directly underthe Central Government, in which the drug manufacturer is located; where theapplicants are all drug manufacturers, the application shall be submitted tothe drug regulatory department of the province, autonomous region, ormunicipality directly under the Central Government, in which the manufacturerof pharmaceutical preparations is located; where none of the applicants is adrug manufacturer, the application shall be submitted to the drug regulatorydepartment of the province, autonomous region, or municipality directly under theCentral Government, in which the site for pilot production of drug samples islocated.

Article 18 An applicant shall provide theinformation on patent and its ownership of the applicant or other parties inChina, in respect of the drug applied for registration, its formula,manufacturing processes and/or uses, etc. Where another party owns the patentin China, the applicant shall provide a statement of non-infringement. The drugregulatory department shall publish the information or the statement submittedby the applicant on its official website.

Where a patent dispute occurs in the process of drugregistration, it shall be settled in accordance with relevant laws andregulations on patent.

Article 19 For a drug patented in China,applicants other than the patentee may submit the application for registrationtwo years prior to the expiry date of the patent. The State Food and DrugAdministration shall review the drug application in accordance with theProvisions, and after the expiry date of the patent, check and issue the drugapproval number, Import Drug License or a Pharmaceutical Product License if theapplication conforms with the provisions.

Article 20 In accordance with the provisions inArticle 35 of the Regulations for Implementation of the Drug AdministrationLaw, where a manufacturer or distributor submits undisclosed drug experimentaland other data which are independently acquired in order to obtain approval forproduction or marketing of the drug in question which contains any new chemicalentity, the State Food and Drug Administration shall, within six years from theapproval date of the drug, reject any application made by any other applicantsby using the undisclosed data of the drug in question without permission of theoriginal applicant who has obtained the drug approval, unless the datasubmitted are independently acquired by the applicants other than the originalone.

Article 21 Pre-clinical drug study for drugregistration application includes drug synthetic processes, extraction methods,physical and chemical properties, purity, selection of dosage form, screeningof formula, preparing processes, testing methods, quality specifications,stability, pharmacology, toxicology and animal pharmacokinetics, etc. Fortraditional Chinese medicine preparations, in addition to the above-mentioneditems, pre-clinical drug study also includes the study in the source of thecrude drugs, and of their pre-treatment and processing, etc. For biologicalproducts, it also includes study on the source, quality specifications, storageconditions, biological characteristics and genetic stability of the startingmaterials such as bacterial and viral seeds/strains, cell lines, bio-tissues,and immunological study, etc.

Article 22 A pre-clinical drug study shall be inconformity with relevant requirements, among which the Good Laboratory Practicefor Non-Clinical Laboratory Studies shall be implemented in the study of safetyevaluation.

Article 23 The drug research institution shallhave relevant staff, premises, equipment, instruments and management system,which are appropriate to the research project, and ensure the authenticity ofall experimental data. Experimental animals, reagents and raw materials used inthe study shall conform with the provisions of the State.

Article 24 An applicant who entrusts otherinstitutions with a drug research, individual experiment, testing, or pilotproduction, etc. shall conclude a contract with the trustee, and state itclearly in the registration application. The applicant shall be responsible forthe authenticity of the research data in the application dossier.

Article 25 Where the application is only forregistration of pharmaceutical preparations, any drug substance used for thestudy shall have a drug approval number, an Import Drug License or aPharmaceutical Product License, and be acquired through legitimated means.Where a drug substance used for the study has no drug approval number, ImportDrug License or Pharmaceutical Product License, the use of drug substance in studyshall be approved by the State Food and Drug Administration.

Article 26 The research data in applicationdossier for drug registration provided by an overseas drug research institutionshall be attached with the items and pages of the information, and withnotarized documents proving that the said drug research institution is legallyregistered overseas. The State Food and Drug Administration may send staff toconduct on-site inspection in needs of drug review.

Article 27 The drug regulatory department mayrequest the applicant or the drug research institution responsible for testingto repeat the test based on the items, methods and data specified in theapplication documents, and may also authorize a drug testing institute oranother drug research institution to repeat the test or conduct methodologicalverification.

Article 28 The drug study shall be conductedaccording to the relevant technical guidelines issued by the State Food andDrug Administration. Where an applicant conducts the study by adopting otherevaluation methods and techniques, supporting data proving the scientificfeasibility of such methods and techniques shall be provided.

Article 29 An applicant who obtains the drugapproval number shall manufacture according to the manufacturing processesapproved by the State Food and Drug Administration.

The drug regulatory department shall supervise and inspect theapplicant's manufacture in accordance with the approved manufacturing processesand quality specifications.

Chapter III
Drug Clinical Trials

Article 30 Any drug clinical trial, includingbioequivalence study, shall be approved by the State Food and DrugAdministration, and shall be in compliance with the Good Clinical Practice.

Drug regulatory department shall supervise and inspect theapproved clinical trials.

Article 31 Clinical trials shall be conducted fornew drug registration applications. As for generic drug registrationapplications and supplementary applications, clinical trials shall be conductedin accordance with the requirements in the Annex of the Provisions.

A clinical trial consists of phases I, II, III and IV.

Phase I Clinical Trial: initial clinical pharmacology andsafety evaluation studies in humans. These studies are designed to observetolerability of humans to and pharmacokinetics of a new drug, in order toprovide basis for establishing the administration regimen.

Phase II Clinical Trial: preliminary evaluation of therapeuticeffectiveness of a drug. The purposes are to preliminarily evaluate thetherapeutic effectiveness and safety of the drug for particular indication(s)in patients, and provide evidence for design of Phase III clinical trial andsettlement of administrative dose regimen. According to specific trialobjectives, this phase of trial may be designed in various forms, including therandomized blind controlled clinical trial.

Phase III Clinical Trial: confirmation of therapeuticeffectiveness of a drug. The purposes are to further verify drug therapeuticeffectiveness and safety on eligible patients with target indication(s), toevaluate overall benefit-risk relationships of the drug, and to ultimatelyprovide sufficient evidence for the review of drug registration application.The study, in general, shall be a randomized blind controlled trial with an adequatesample size.

Phase IV Clinical Trial: a new drug post-marketing study. Thepurposes are to assess therapeutic effectiveness and adverse reactions when adrug is widely used, to evaluate overall benefit-risk relationships of the drugwhen used among general population or specific groups, and to adjust theadministration dose, etc.

Bioequivalence study refers to a human study, which appliesbioavailability study methods with pharmacokinetic parameters as indicators tocompare active ingredient absorption rate and extent of the preparations in thesame or different dosage forms of a drug in terms of statistical differencesunder the same experimental condition.

Article 32 The sample size of a drug clinicaltrial shall conform to the objectives of the clinical trial and fulfillstatistical requirements, and shall be no smaller than the minimum number ofsubjects required by the Annex of the Provisions. Where there arecircumstances, regarding rare or special diseases, etc., which request clinicalsample size reduction or clinical trial exemption, a request shall be made withthe clinical trial application, and reviewed and approved by the State Food andDrug Administration.

Article 33 As for vaccines prepared duringbacterial or viral strain screening or other special drugs, if confirmedwithout any suitable animal model and laboratory measurement in terms ofcurative effectiveness, clinical trials may be applied for to the State Foodand Drug Administration, subject to ensuring the safety of trial subjects.

Article 34 When a drug clinical trial isapproved, the applicant shall select institutions for the clinical trial fromthose certified for conducting drug clinical trials.

Article 35 Drugs used for clinical trials shallbe manufactured in facilities in compliance with the Good ManufacturingPractice for Pharmaceutical Products (GMP). The manufacturing process shallstrictly meet the requirements of the GMP.

The applicant shall be responsible for the quality of the drugsused for clinical trials.

Article 36 The applicant may conduct the testingfor clinical trial drugs by itself, or entrust a drug testing institutespecified in the Provisions to conduct such testing, according to its proposedspecifications. Vaccines, blood products and other biological productsspecified by the State Food and Drug Administration shall be tested by drugtesting institutes designated by the State Food and Drug Administration.

A drug can be used for a clinical trial only after tested asqualified.

Drug regulatory departments may conduct sampling and testing ondrugs used for clinical trials.

Article 37 Prior to conducting a clinical trial,the applicant shall report to the State Food and Drug Administration for recordwhile copying to the drug regulatory department of the seat of the clinicaltrial institution and that of the province, autonomous region or municipalitydirectly under the Central Government to receive the application a confirmedclinical trial protocol, the name of the principal investigator at theinstitution in charge of the clinical trial, a list of participatinginstitutions and names of investigators wherefrom, an ethic committee approvalletter, and a template of the informed consent form, etc.

Article 38 Where the applicant finds a clinicaltrial institution violating relevant regulations or failing to implement theclinical trial protocol, it shall urge the institution to make corrections; ifthe circumstances are serious, the applicant may demand suspension ortermination of the clinical trial, and shall report the matter to the StateFood and Drug Administration and the drug regulatory departments of therelevant provinces, autonomous regions or municipalities directly under theCentral Government.

Article 39 After completion of a clinical trial,the applicant shall submit a clinical trial final report, a statisticalanalysis report and its database to the State Food and Drug Administration.

Article 40 A clinical trial shall be conductedwithin three years after approval. If overdue, the original approval documentsshall be invalid. If the clinical trial is still needed, the application shallbe reapplied for.

Article 41 If any serious adverse event occursduring the clinical trial, the investigators shall report to the drugregulatory departments of the relevant provinces, autonomous regions ormunicipalities directly under the Central Government and the State Food andDrug Administration and notify the applicant within 24 hours, and report to theethic committee in time.

Article 42 In any of the following circumstancesduring a clinical trial, the State Food and Drug Administration may order theapplicant to modify the protocol, suspend or terminate the clinical trial,:

(1) the ethic committee fails toperform its duty;
(2) safety of the subjects cannot be adequately ensured;
(3) a serious adverse event is not reported within the specified timeline;
(4) there is evidence to prove that the drug used for the clinical trial is noteffective;
(5) a quality problem of the drug used for the clinical trial occurs;
(6) there is a fraud in the clinical trial; or
(7) there is any other case violating the Good Clinical Practice.

Article 43 Where there is any large-scale of andunexpected adverse reaction or serious adverse event, or there is evidence toprove any serious quality problem of the drug used for a clinical trial, theState Food and Drug Administration or the drug regulatory department of theprovince, autonomous region or municipality directly under the CentralGovernment may take emergency control measures and order to suspend orterminate the clinical trial. The applicant and clinical trial institution muststop the clinical trial immediately.

Article 44 An overseas applicant intending toconduct an international multi-center clinical trial in China shall submit anapplication to the State Food and Drug Administration in accordance with theProvisions, and fulfill the following requirements:

(1) the drugs used for clinical trialsshall be already approved or in phase II or III clinical trial overseas. The StateFood and Drug Administration does not accept any overseas applicant’sinternational multi-center clinical trial application for any preventivevaccine not being registered overseas yet;
(2) while approving to conduct an international multi-center clinical trial,the State Food and Drug Administration may require the applicant to conductphase I clinical trial first in China;
(3) when conducting an international multi-center clinical trial in China, ifthere are any observed serious adverse reaction and unexpected adverse reactionassociated with the drug in any country, the applicant shall, in accordancewith relevant regulations, report to the State Food and Drug Administration intime;
(4) the applicant shall submit a complete clinical trial report to the StateFood and Drug Administration after the completion of a clinical trial; and
(5) the data obtained from an international multi-center clinical trial fordrug registration application in China shall be in conformity with therequirements on clinical trial in the Provisions. All the study materials ofthe international multi-center clinical trial shall be submitted.

Chapter IV
Application and Approval of New Drugs

Article45The State Food and Drug Administration may implement special review and approvalin cases of the following applications:

(1) active ingredients extracted fromplants, animals and minerals, etc. and their preparations not yet marketed inChina, and newly discovered Chinese crude drugs and their preparations;
(2) chemical drug substances and their preparations and biological products notyet approved for marketing in China or abroad;
(3) new drugs for the treatment of diseases such as AIDS, malignant tumors andrare diseases, etc. with significant clinical advantage; and
(4) new drugs for the treatment of diseases, for which effective therapeuticmethods are not available.

For drugs specified in the previous clause, applicants mayapply for special review and approval in the process of drug registration. TheCenter for Drug Evaluation of the State Food and Drug Administration shallorganize expert meetings to discuss and determine whether or not to conductspecial review and approval for the drugs.

Specified measures for special review and approval shall beformulated separately.

Article 46 Where a new drug is co-developed byseveral institutions, the registration can be applied for by one of theinstitutions, and its duplicate application shall not be made by the others. Ifa joint application for registration is needed, the institutions shall co-signas the applicant of the new drug. Each approved new drug, including itsdifferent strengths shall be produced by only one institution.

Article 47 For the registration application tochange the dosage form without changing administration route of a marketeddrug, new techniques shall be employed to improve the drug quality and safety,and the changed dosage form shall have significant clinical advantage comparedwith the previous dosage form.

Registration applications to change the dosage form withoutchanging the route of administration or to claim any new indication shall besubmitted by certified manufacturers, with exceptions for special dosage formssuch as targeting delivery, sustained release and controlled releasepreparations, etc.

Article 48 In the process of the review andapproval of a new drug, the registration classification and technicalrequirements thereof shall not be changed, even though the preparations of thesame active ingredients are approved for marketing abroad.

In the process of the review and approval of a new drug, theregistration classification and technical requirements thereof shall not bechanged, even though the preparations of the same active ingredients appliedfor by domestic manufacturers are approved for marketing in China.

Article 49 The dossier for drug registrationapplication shall be submitted at one time. No other technical materials shouldbe added by the applicant after a drug registration application is accepted,with the exceptions for applications of special review and approval, newfinding regarding drug safety, or supplementary materials as required. Where anapplicant deems it integrant for any new technical material to be supplemented,the submitted application shall be withdrawn. Only if no same product is in thenew drug observation period, the applicant may re-apply in compliance with therelevant requirements in the Provisions.

Section 1
Clinical Trials for New Drugs

Article 50 After completing the pre-clinicalstudy, the applicant shall fill the Application Form for Drug Registration, andreport authentically relevant materials to the drug regulatory department ofthe province, autonomous region or municipality directly under the CentralGovernment where the applicant is located.

Article 51 Drug regulatory departments ofprovinces, autonomous regions, or municipalities directly under the CentralGovernment shall conduct the preliminary review of the application dossiers,and issue a acceptance notice of drug registration application if requirementsare met, or issue a non-acceptance notice, in which reasons shall be given, ofdrug registration application if requirements are not met.

Article 52 Drug regulatory departments ofprovinces, autonomous regions, or municipalities directly under the CentralGovernment shall organize to conduct on-site inspections of the drug researchand development conditions and raw data, make preliminary review of thesubmitted dossiers, and provide review opinions within five days from the dateit accepts an application. Where the drug for which the registration is appliedis a biological product, samples from three production batches thereof shallalso be collected for testing, and a notice for the testing for registrationshall be issued to the drug testing institute.

Article 53 Drug regulatory departments ofprovinces, autonomous regions, or municipalities directly under the CentralGovernment shall deliver the review opinions, inspection reports and theapplication dossiers to the Center for Drug Evaluation of the State Food andDrug Administration within the specified timeline, and notice the applicants.

Article 54 The drug testing institute thatreceives a notice for the testing for registration shall test the samplesaccording to the drug specifications submitted by the applicant, verify thesubmitted drug specifications, and submit a certificate of analysis for drugregistration to the Center for Drug Evaluation of the State Food and DrugAdministration within the specified timeline, and copy to the applicant.

Article 55 After receiving submitted dossiers,the Center for Drug Evaluation of the State Food and Drug Administration shallorganize pharmaceutical, medical and other technical personnel to conducttechnical review of the submitted dossiers within the specified timeline, andmay request, with reasons, applicants to provide supplementary materials whennecessary. After completing technical reviews, the Center for Drug Evaluationshall give technical review opinions and report together with relevant documentsto the State Food and Drug Administration.

The State Food and Drug Administration shall make review andapproval decisions based on the technical review opinions. Where theregulations are conformed to, a Drug Clinical Trial Approval shall be issued;where the regulations are not conformed to, a Disapproval Notice shall beissued with reasons provided.

Section 2
Production of New Drugs

Article 56 After completing drug clinical trials,applicants shall fill the Application Form for Drug Registration, submitproduction application dossiers to the drug regulatory departments of theprovinces, autonomous regions, or municipalities directly under the CentralGovernment where the applicant is located, and at the same time provide the rawmaterials and research information for preparing reference standards to theNational Institute for the Control of Pharmaceutical and Biological Products.

Article 57 Drug regulatory departments ofprovinces, autonomous regions, or municipalities directly under the CentralGovernment shall conduct the preliminary review of the application dossiers,and issue an acceptance notice of drug registration application if requirementsare met, or issue a non-acceptance notice, in which reasons shall be given, ofdrug registration application if requirements are not met.

Article 58 Drug regulatory departments ofprovinces, autonomous regions, or municipalities directly under the CentralGovernment shall organize to conduct on-site inspections of the drug researchand development conditions and raw data, make preliminary review of thesubmitted dossiers, and provide review opinions within five days from the dateit accepts an application. For the other drugs except biological products,samples of three production batches shall also be collected for testing, and anotice of specifications verification shall be issued to the drug testinginstitute.

Drug regulatory departments of provinces, autonomous regions,or municipalities directly under the Central Government shall deliver thereview opinions, inspection reports and the application dossiers to the Centerfor Drug Evaluation of the State Food and Drug Administration within thespecified timeline, and notice the applicants.

Article 59 Drug testing institutes shall verifythe submitted drug specifications and give the verification opinions to theCenter for Drug Evaluation of the State Food and Drug Administration within thespecified timeline, and at the same time copy to the drug regulatorydepartments of the provinces, autonomous regions, or municipalities directlyunder the Central Government that notify them to conduct the verification, andthe applicants.

Article 60 After receiving submitted dossiers,the Center for Drug Evaluation of the State Food and Drug Administration shallorganize pharmaceutical, medical and other technical personnel to conducttechnical review of the submitted dossiers within the specified timeline, andmay request, with reasons, applicants to provide supplementary materials whennecessary.

Where the regulations are conformed to as reviewed, the Centerfor Drug Evaluation of the State Food and Drug Administration shall notice theapplicant to apply for production site inspection and inform the Center forDrug Certification of the State Food and Drug Administration. Where theregulations are not conformed to as reviewed, the Center for Drug Evaluation ofthe State Food and Drug Administration shall report the review opinions andrelevant documents to the State Food and Drug Administration; the State Foodand Drug Administration shall make a disapproval decision to the applicationbased on the technical review opinions, and issue a Disapproval Notice withreasons.

Article 61 The applicant shall apply for on-siteinspection to the Center for Drug Certification of the State Food and DrugAdministration within six months from the date it receives the notice ofproduction site inspection.

Article 62 The Center for Drug Certification ofthe State Food and Drug Administration shall, within 30 days from the date itreceives the application for production site inspection, organize on-siteinspection of large-scale samples production, verify the applicability of themanufacturing processes and at the same time take samples of one batch ofproducts (samples of three batches of products for biological products), andprovide production site inspection report to the Center for Drug Evaluation ofthe State Food and Drug Administration within ten days after the siteinspection.

Article 63 Samples shall be produced at a plantwith the GMP Certificate. As for a new manufacturer, a new workshop establishedor the production of a dosage form added at an existing manufacturer, thesample production shall meet the GMP requirements.

Article 64 Drug testing institutes shall conductsample testing according to the verified specifications, and within thespecified timeline, provide testing reports to the Center for Drug Evaluationof the State Food and Drug Administration, and copy to the relevant drugregulatory departments of the provinces, autonomous regions, or municipalitiesdirectly under the Central Government and the applicants.

Article 65 The Center for Drug Evaluation of theState Food and Drug Administration shall make a general opinion based on thetechnical review opinions, production site inspection reports and sampletesting results, and report the general opinion together with relevantdocuments to the State Food and Drug Administration. The State Food and DrugAdministration shall make a review and approval decision based on the generalopinion. Where the regulations are conformed to, a New Drug Certificate shallbe issued; if the applicant already has a Drug Manufacturing Certificate andpossesses the production conditions, a drug approval number shall be issued atthe same time; where the regulations are not conformed to, a Disapproval Noticeshall be issued with reasons.

A New Drug Certificate shall not be issued to the approvedregistration applications for changing dosage forms without changing route ofadministration or claiming for new indications, with exceptions for specialdosage forms such as targeting delivery, sustained release and controlledrelease preparations, etc.

Section 3
New Drug Observation Period

Article 66 In order to protect the public health,the State Food and Drug Administration may set an observation period for anynew drug approved for production. The observation period of a new drug shall beno longer than five years from the date the drug is approved for production.

During the observation period of a new drug, the State Food andDrug Administration shall not approve other manufacturers to produce, changedosage form of or import the drug.

Article 67 A drug manufacturer shall investigatethe manufacturing processes, quality, stability, therapeutic effect and adversereactions, etc. of a new drug in the observation period, and report annually tothe drug regulatory department of the province, autonomous region, ormunicipality directly under the Central Government, where it is located. Wherea drug manufacturer fails to perform its duties in the observation period, thedrug regulatory department of the province, autonomous region, or municipalitydirectly under the Central Government shall order it to make rectifications.

Article 68 Where institutions for drug manufacturing,distribution, use, testing or supervision find any critical quality problem,serious or unexpected adverse reaction of a new drug, they shall report to thedrug regulatory department of the province, autonomous region, or municipalitydirectly under the Central Government in time. Once receiving the report, thedrug regulatory department of a province, autonomous region, or municipalitydirectly under the Central Government shall organize prompt investigation, andreport to the State Food and Drug Administration.