Chapter V Application and Examination & Approval of New Drugs

　　Section I Basic Requirements

　　Article 48 The materials submitted for the application for registration¹ of new drugs shall be complete and normative, and the data must be true and reliable; the documentary materials quoted shall be marked with the title of the work, title of the publication, as well as the volume, issue and page etc; the documentary materials not publicly published shall be accompanied with the certifications of permission of use by the owner of the materials. Materials in foreign languages shall be accompanied with Chinese translations pursuant to the requirements.

　　Article 49 The SDA shall make an accelerated examination and approval with respect to the applications for the following new drugs:

　　（1） New Chinese medicine materials, effective components² extracted from Chinese medicines or natural drugs, as well as the preparations of those components;

　　（2） Chemical raw materials medicines, as well as the preparations and biological products thereof, that haven''t been approved to be marketed home and abroad;

　　（3） New drugs that fight against AIDS virus and that are used in the diagnosis³ and prevention of AIDS, new drugs treating malignant⁴ tumours⁵ and rare diseases etc;

　　（4） New drugs treating the diseases that can''t be cured by effective means yet.

　　Article 50 The drug administration of a province, autonomous⁶ region and municipality directly under the Central Government shall, after receiving an application for registration of any new drug listed in Article 49 of these Measures, make the examination and give opinions on whether that application meets the conditions for accelerated examination and approval. The SDA shall determine whether to make an accelerated examination and approval for that application for new drug upon the acceptance of it.

　　Article 51 With respect to any new drug jointly⁷ developed by several entities⁸, the application for registration may be filed by one entity⁹ among them, and the other entities may not file the application any more. Except the drugs listed in Subparagraphs 1） and 2） of Article 49 of these Measures, after the application for a new drug is approved, each category of such drug may only be manufactured by one entity, and different specs of the same category may not be manufactured by different entities.

　　Article 52 In the examination process of a new drug, if the technical requirements for that new drug are changed because the same category of drug is allowed to go on the market overseas, the original technical requirements shall remain unchanged.

　　Section II Examination & Approval of Clinical Study of New Drugs

　　Article 53 After finishing the investigational¹¹ study of new drugs, an applicant¹² shall fill in the Application Form for Drug Registration, and faithfully submit the relevant materials and drug samples to the drug administrations of the province, autonomous region or municipality directly under the Central Government.

　　Article 54 The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of form of the application materials, organize an on-spot investigation¹⁰ of the manufacturing process and conditions, select samples for inspection¹³ use, and send notice on registration inspection to the designated institute for drug control. The administration shall, after finishing the aforesaid work, submit the examination opinions, investigation report and application materials to the SDA, and notify the applicant.

　　Article 55 The institute for drug control receiving the notice on registration inspection shall make an inspection on the selected samples, check the drug standards of the application, and submit the inspection report and check opinions to the SDA within the prescribed time limit, and shall send those documents to the drug administration of the province, autonomous region or municipality directly under the Central Government that sent the notice on inspection and to the applicant.

　　Article 56 With respect to the application materials for clinical study of new drugs submitted by the drug administration of the province, autonomous region or municipality directly under the Central Government, the SDA shall accept the application if the requirements are met after examination, issue the notice on acceptance, and may request the applicant to supply drug samples if necessary.

　　Article 57 After accepting an application for new drugs, the SDA shall organize professionals in pharmacology, medicine and other technical fields to make the technical evaluation¹⁴ of the new drugs, and decide on whether or not to approve the clinical study of such drugs by the form of Official Letter on Clinical Study of Drugs.

　　Article 58 If the institute for drug control deems that the drug standard supplied can''t control the quality, the applicant may withdraw its application for new drugs. If the application is not withdrawn¹⁵, the SDA may return such application if it is determined¹⁶ that the drug standard can''t control the quality after examination.

　　Article 59 If it does not accord with its medicines standard declared that the sample is examined, the SDA may return the drug''s application after examination.

　　Article 60 If a withdrawn application for new drugs meets the conditions for application after the applicant makes study over again, it may be filed again and be processed pursuant to the original application procedures.

　　Article 61 During the examination of an application for drug registration by the SDA, no new technical materials may be supplemented except for innovative¹⁷ drug components or new discoveries involving the safety of drugs. If it is a must to supplement new technical materials, the applicant shall withdraw its application for drug registration and file a new one pursuant to the original procedures.

　　Section III Examination & Approval of Manufacture of New Drugs

　　Article 62 After finishing the clinical study of drugs, an applicant shall submit the clinical study materials and other modified and supplemented materials to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, explain the basis and reasons in details, and send the raw materials of the standard products to the National Institute for the Control of Pharmaceutical¹⁸ and Biological Products at the same time.

　　Article 63 The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of form of the application materials; organize an on-spot investigation of the manufacturing process and conditions; select samples from products of 3 successive batch¹⁹ numbers, and send notice on registration inspection to the designated institute for drug control; submit the examination opinions, investigation report and application materials to the SDA within the prescribed time limit, and notify the applicant.

　　Article 64 The 3 batches²⁰ of samples needed for application for new drugs shall be manufactured in the workshops with the certificate of Criterions for the Quality Control of Drug Manufacturing; for newly initiated²¹ drug manufacturing enterprises, newly established drug manufacturing workshops of drug manufacturing enterprises, or newly added form of preparations to be manufactured, the manufacturing process of samples thereof must conform to the requirements of the Criterions for the Quality Control of Drug Manufacturing.

　　Article 65 An institute for drug control receiving the notice on registration inspection shall make an inspection over the selected samples, and submit the inspection report to the SDA within the prescribed time limit, and at the same time send a copy to the drug administration of the province, autonomous region or municipality directly under the Central Government where the inspection is conducted, and to the applicant.

　　Article 66 With respect to the materials submitted by the drug administration of the province, autonomous region or municipality directly under the Central Government, the SDA shall accept the application if the requirements are met after examination, and issue the notice on acceptance.

　　Article 67 The SDA shall make an overall review of the materials submitted, and decide on whether to approve or not by the form of Official Document on Drug Registration. New drug certificate shall be issued if the requirements of the provisions are met; and the registered number of approval for drugs shall at the same time be issued if the applicant possesses the License²² for Drug Manufacturing and the corresponding conditions for manufacturing of that drug.

　　Article 68 When approving an application for new drug, the SDA shall at the same time promulgate²³ the registration standard and specifications²⁴ of that drug.

　　Drug specifications shall be verified by the SDA according to the application materials submitted by the applicant. A drug manufacturing enterprise shall be responsible for the correctness and accuracy of the drug specifications, follow up the safety and effectiveness of the drug after it goes on the market, and shall file an application for modifying the drug specifications without delay if necessary.

　　Drug specifications shall be printed pursuant to the provisions of the SDA.

　　Article 69 Where the 3 batches of drugs manufactured for the application for new drugs were manufactured in the workshops with the License for Drug Manufacturing and the Criterions for the Quality Control of Drug Manufacturing, those drugs may be marketed within their effective periods after passing the inspection conducted by the institute for drug control designated by the SDA and obtaining the registered number of approval for drugs.

　　Section IV Administration of the Monitoring Periods of New Drugs

　　Article 70 With a view to protecting the public health, the SDA may set forth²⁵ monitoring periods for new drugs approved to be manufactured, to continually monitor the safety of those new drugs.

　　The SDA will not approve other enterprises to manufacture or import new drugs within the monitoring periods.

　　Article 71 The monitoring period of a new drug shall be calculated starting from the day of approval for manufacturing of that new drug, and may not exceed 5 years. With respect to different new drugs, different monitoring periods shall be determined according to the existing safety study materials and domestic and overseas study process concerning such drugs.

　　Article 72 Where a new drug enters the monitoring period, the SDA will no longer accept any application for new drug of the same category filed by any other applicant. The drug administration of the province, autonomous region or municipality directly under the Central Government shall return the other applications already received to the applicants²⁶.

　　Article 73 For a new drug within the monitoring period, the drug manufacturing enterprise shall regularly inspect the manufacturing techniques, quality, stability, curative effect and adverse²⁷ reactions etc, and report each year to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located.

　　Where the entities relating to the manufacturing, operation, use, or inspection or supervision²⁸ of drugs find out that the new drug has serious quality problems, or causes serious or unanticipated adverse reactions, they must report without delay to the drug administration of the province, autonomous region or municipality directly under the Central Government.

　　Article 74 With respect to the new drug with serious quality problems, or causing serious or unanticipated adverse reactions, the drug administrations of the province, autonomous region or municipality directly under the Central Government shall organize investigation immediately and report to the SDA.

　　Article 75 If a drug manufacturing enterprise don''t fulfil responsibility of a new drug during the monitoring period in accordance with provisions, the drug administration of the province, autonomous region or municipality directly under the Central Government should order it to correct.

　　Article 76 If a new drug for which the monitoring period has been set has not been manufactured within 2 years from the day of approval, the SDA may approve the applications for manufacturing that new drug filed by other drug manufacturing enterprises, and continue the monitoring.

　　Article 77 Where the SDA has already approved any other applicant to conduct clinical study of drugs before a new drug enters the monitoring period, such application may continue to be processed pursuant to the procedures for application and examination and approval of drug registration; the SDA may approve the manufacturing or importing of the drug if it meets the requirements of the provisions, and monitor it together with such new drug manufactured by domestic drug manufacturing enterprises.

　　Article 78 Where the SDA has already accepted but not yet approved any other applicant to conduct clinical study of drugs before a new drug enters the monitoring period, such application shall be returned; after the monitoring period of such new drug ends, the applicant may file an application for registration of drugs with existing state standards.

　　Article 79 If an imported drug has been approved to be registered and marketed before any domestic applicant is approved to conduct clinical study, the application may continue to be processed pursuant to the procedures for application and examination and approval of drug registration; the SDA may approve the manufacturing of the drug if the requirements are met; and the applicant may also withdraw that application and file a new application for registration of drugs with existing state standards. If the application for clinical study filed by any other applicant has been accepted but not yet approved, such application shall be returned; a new application shall be filed pursuant to the requirements for registration of drugs with existing state standards.

　　Chapter VI Application and Examination & Approval of Drugs with Existing State Standards

　　Article 80 To apply for the manufacturing of drugs with existing state standards, the applicant shall be a drug manufacturing enterprise with the License for Drug Manufacturing and with the certificate of Criterions for the Quality Control of Drug Manufacturing. The drug for which the application is filed shall fall within the manufacturing scope specified²⁹ in the License for Drug Manufacturing and the certificate of Criterions for the Quality Control of Drug Manufacturing.

　　Article 81 If the certificate of Criterions for the Quality Control of Drug Manufacturing hasn''t been obtained for a newly initiated drug manufacturing enterprise, for a newly established drug manufacturing workshop of a drug manufacturing enterprise, or for the adding of new form of preparations to be manufactured, the said certificate shall be obtained within the time limit provided for in Article 6 of the Implementation³⁰ Regulations; if the certificate is not obtained within that period, the registered number of approval for drugs shall be invalidated automatically, and shall be written off by the SDA.

　　Article 82 An applicant shall finish the trial manufacturing pursuant to the relevant technical requirements, fill out the Application Form for Drug Registration, and submit the relevant materials and drug samples to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located.

　　Article 83 The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of form of the application materials, accept the application if the requirements are met, and issue the notice on acceptance; organize an on-spot inspection of the manufacturing process and conditions, select samples from the products of 3 successive batch numbers, notify the designated institutes for drug control to inspect the samples; and submit the examination opinions and application materials to the SDA within the prescribed time limit, and notify the applicant.

　　Article 84 An institute for drug control receiving the notice on registration inspection shall make an inspection on the selected samples, and send the inspection report to the SDA within the prescribed time limit, and at the same time send a copy to the drug administration of the province, autonomous region or municipality directly under the Central Government, which notified it to make the inspection, and to the applicant.

　　Article 85 The SDA shall make a comprehensive evaluation of the materials submitted, and issue the Official Letter on Clinical Study of Drugs if clinical study is needed.

　　After finishing the clinical study, the applicant shall submit the clinical study materials to the SDA.

　　Article 86 The SDA determines to approve producing at form on the Official Letter on Clinical Study of Drugs. The one which accords with the provisions is issued the registered number of approval for drugs.

　　Article 87 The SDA and the drug administration of the province, autonomous region or municipality directly under the Central Government will not accept any application filed on the basis of tentative standards for registration of drugs with existing state standards.

　　Article 88 With respect to an application for registration of drugs with existing state standards which need further evaluation of curative effect and safety, the SDA may suspend the acceptance and examination & approval.

　　Article 89 If the 3 batches of drugs manufactured for the application for the registered number of approval for drugs were manufactured in workshops with the License for Drug Manufacturing and the certificate of Criterions for the Quality Control of Drug Manufacturing, those drugs may be marketed within their effective periods after passing the inspection conducted by the institute for drug control designated by the SDA and obtaining the registered number of approval for drugs.

　　Chapter VII Application and Examination & Approval of Imported Drugs

　　Article 91 For the application for import of drugs, permission for marketing³² by the country or region where the overseas drug manufacturer is located must be obtained; if no permission for marketing has been obtained, but the SDA confirms that the said drugs are safe, effective and needed for clinical use, the import thereof may be approved.

　　The drug of which import is applied³³ for shall meet the criterions on quality control of drug manufacturing of the country or region where it is manufactured and the requirements of the Criterions for the Quality Control of Drug Manufacturing of China.

　　Article 91 To apply for the registration of imported drugs, an applicant shall fill in the Application Form for Drug Registration, submit the relevant materials and samples, supply the relevant certifications and file the application with the SDA.

　　Article 92 The SDA shall make an examination of form of the submitted materials, accept the application if the requirements are met, issue the notice on acceptance and notify the National Institute for the Control of Pharmaceutical and Biological Products to conduct drug registration inspection.

　　The SDA shall, according to the needs, make on-spot investigations³⁴ of the developing process and manufacturing conditions.

　　Article 93 After finishing the registration inspection of the imported drug, the National Institute for the Control of Pharmaceutical and Biological Products shall submit the reviewed drug standard, inspection report and review opinions to the SDA.

　　Article 94 The SDA shall organize a comprehensive evaluation of the submitted materials, and decide on whether or not to approve the clinical study by the form of Official Letter on Drug Clinical Study.

　　Article 95 After the clinical study has been approved, the applicant shall carry it out pursuant to Chapter 4 of these Measures and the relevant requirements.

　　After the clinical study is ended, the applicant shall submit the clinical study materials, samples and other modified and supplemented materials pursuant to the provisions, explain the basis and reasons in details, and supply the relevant certifications.

　　Article 96 The SDA shall make a comprehensive evaluation of the clinical study materials etc submitted, and issue the Registration Certificate of Imported Drugs if the requirements are met. The Registration Certificate of Pharmaceutical Products shall be issued if the drug is registered by a drug manufacturer of Hong Kong, Macao or Taiwan areas of China.

　　Article 97 For the application for importing drug preparations, certifications of legal sources of the packaging materials and containers directly contacting the drugs, and certifications of legal sources of the raw material medicines and supplementary³⁵ materials used to manufacture those preparations must be provided. If the raw material medicines and supplementary materials haven''t been approved by the SDA, the study materials relating to the manufacturing techniques, quality indications and inspection methods shall be submitted.

　　Article 98 When approving the import of the drug, the SDA shall at the same time promulgate the ratified³⁶ registration standard and specifications of the imported drugs.

　　Chapter VIII Application and Examination & Approval of Nonprescription Drugs

　　Article 99 Nonprescription drugs shall refer to the drugs promulgated³⁸ by the SDA that the customers may judge, purchase and use by themselves without the prescriptions³⁹ given by practicing physicians and practicing assistant physicians.

　　Article 100 If the drug applying for registration is in any of the following cases, it may apply for being nonprescription drug at the same time:

　　（1） Manufacturing or import of a nonprescription drug with existing state drug standard;

　　（2） Being a drug of a changed form of preparations of a nonprescription drug determined by the SDA, but with the same applicable diseases, dosage administration and route of administration;

　　（3） Being a new compound preparation composed of the activated⁴⁰ components of nonprescription drugs determined by the SDA.

　　Article 101 For a drug registration application that meets the requirements of the relevant provisions of the state on nonprescription drugs, the SDA shall determine the drug as nonprescription drug when approving the manufacturing or import of that drug.

　　A drug that can''t apply for registration as nonprescription drug may only apply for conversion⁴¹ into nonprescription drug after wide range of clinical application.

　　Article 102 Manufacturing and import of nonprescription drugs with existing state drug standards shall be dealt with pursuant to Chapter 6 and Chapter 7 of these Measures.

　　Article 103 If the form of preparations of any nonprescription drug has been changed without changing the route of administration, and the changed form of preparations meet the requirements for nonprescription drugs, generally, no clinical trial is required, however, bioequivalence trial shall be conducted with respect to solid preparations for oral use.

　　Article 104 With respect to the new compound preparations composed of the activated components of nonprescription drugs determined by the SDA, the prescription³⁷ basis shall be specified, and clinical trial shall be conducted if necessary.

　　Article 105 The languages used in the specifications of nonprescription drugs shall be scientific and understandable to facilitate the customers to judge, choose and use those drugs by themselves, and must be ratified by the SDA. The packaging of nonprescription drugs must bear the special marks for nonprescription drugs prescribed by the SDA.

　　Article 106 Where any nonprescription drug approved by the SDA has been found unsuitable for being nonprescription drug during the use, the SDA may change it into prescription drug.

　　Chapter IX Supplementary Drug Application and Examination & Approval Thereof

　　Article 107 If the approval certifications of a drug as well as the drug standard, drug specifications and matters indicated in the labels attached are changed, and the change of manufacturing techniques has affected⁴² the drug quality, the applicant shall file a supplementary application.

　　Article 108 An applicant filing the supplementary application shall be the holder⁴³ of the approval certifications of the drug or the applicant for drug registration.

　　Article 109 The applicant shall fill in the Supplementary Drug Application Form, and submit the relevant materials and explanations to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located. If any change of ownership of the drug is involved, valid³¹ certifications shall be provided.

　　For a supplementary application concerning any imported drug, the applicant shall submit the relevant materials and explanations to the SDA, and present the documents of approval for the change by the drug authorities of the country or region where the drug is manufactured.

　　Article 110 With respect to a supplementary application for adding applicable diseases or functions of the drugs, modifying the drug standard or altering the supplementary materials etc, the drug administration of a province, autonomous region or municipality directly under the Central Government shall give the examination opinions and submit the application to the SDA for examination and approval, and notify the applicant.

　　With respect to a supplementary application for changing the drug packaging specs, altering the enterprise name or modifying the drug standard and specifications pursuant to the requirements of the SDA, the drug administration of a province, autonomous region or municipality directly under the Central Government shall make the examination and approval, submit the application to the SDA for record and notify the applicant.

　　Article 111 If the SDA doesn''t raise any objections within 20 days from receiving the documents for record, the drug administration of a province, autonomous region or municipality directly under the Central Government may notify the applicant to execute that supplementary application.

　　Article 112 With respect to a supplementary application concerning any imported drug, the SDA shall make the examination and approval. For a supplementary application concerning an imported drug of which the examination and approval are conducted on a record basis, if the SDA doesn''t raise any objections within 30 days since the acceptance, the applicant may execute that supplementary application.

　　Article 113 With respect to a supplementary application concerning application for registered number of approval for drugs, change of drug manufacturing address or change of manufacturing techniques etc on the basis of a new drug certificate, the drug administration of a province, autonomous region or municipality directly under the Central Government shall organize investigations of the trial spot, select samples for inspection use, and notify the designated institute for drug control to make an inspection over the samples.

　　With respect to a supplementary application for modifying the drug standard, the institutes for drug control shall review the standard if necessary.

　　Article 114 The SDA shall examine the supplementary drug application and decide whether to approval or not by the form of Official Document on Drug Supplementary Applications. If it is needed to replace the drug approval certifications, the original ones shall be written off; if it is needed to issue new drug approval certifications, the original ones shall remain valid.

　　Article 115 The valid term of the approval certifications for a supplementary drug application shall be identical with that of the original approval certifications, and a new application for registration shall be filed upon the expiration⁴⁴.

　　Chapter X Re-registration of Drugs

　　Article 116 Re-registration of drugs shall refer to the examination and approval conducted on the drugs continuing to be manufactured and imported after the valid term of the drug approval certifications expires.

　　Article 117 The valid term of the registered number of approval for drugs, Registration Certificate of Imported Drugs or Registration Certificate of Pharmaceutical Products issued by the SDA is 5 years. If the manufacturing or import needs to continue after the expiration of the valid term, the applicant shall apply for re-registration within 6 months before the expiration.

　　Article 118 A drug manufacturing enterprise with the registered number of approval for drugs shall file the application for re-registration of drugs with the drug administration of the province, autonomous region or municipality directly under the Central Government, fill in the Application Form for Re-registration of Drugs and supply the relevant application materials.

　　An application for re-registration of imported drugs shall be filed by the applicant with the SDA.

　　Article 119 The drug administration of the province, autonomous region or municipality directly under the Central Government shall, upon the entrustment⁴⁵ by the SDA, finish the examination of the application for drug re-registration within 50 days and submit it to the SDA for record.

　　Article 120 If the SDA doesn''t issue the notice on not granting the re-registration within 50 days from receiving the record materials, the drug administration of the province, autonomous region or municipality directly under the Central Government shall re-register the drugs.

　　Article 121 The SDA shall finish the examination within 100 days from accepting an application for re-registration of imported drugs. And the re-registration shall be made if the application meets the requirements of the provisions.

　　Article 122 In any of the following situations, the drug shall not be re-registered:

　　（1） Failure to file the application for re-registration within the prescribed period;

　　（2） Failure to meet the relevant requirements set forth by the SDA for approval for marketing;

　　（3） Failure to finish Phase IV clinical trial pursuant to the requirements;

　　（4） Failure to monitor the drug adverse reactions pursuant to the provisions;

　　（5） The drug falls within a category to be eliminated as re-evaluated by the SDA;

　　（6） The drug approval certifications should be revoked⁴⁶ pursuant to the Drug Administration Law;

　　（7） Failure to possess the manufacturing conditions provided for in the Drug Administration Law;

　　（8） Failure to perform the responsibilities of monitoring period;

　　（9） Other non-compliance with the relevant provisions.

　　Article 123 If the provisions on re-registration of drugs are not met, the SDA shall issue a notice on not granting the re-registration, and write off the registered number of approval for drugs, Registration Certificate for Imported Drugs or Registration Certificate for Pharmaceutical Products.

　　Chapter XI Transfer of New Drug Technologies

　　Article 124 Transfer of new drug technologies shall refer to the act of the holder of the certificate of a new drug to transfer the manufacturing technologies of the new drug to a drug manufacturing enterprise, with the latter applying for the manufacturing of that new drug.

　　Article 125 Transferor of new drug technologies shall refer to an agency that holds the new drug certificate but hasn''t yet obtained the registered number of approval for drugs; if the registered number of approval for drugs has been obtained, the applicant shall file an application for writing off the original registered number of approval for drugs when applying for transfer of new drug technologies.

　　Article 126 New drug technologies shall be transferred to a drug manufacturing enterprise once off. If the said drug manufacturing enterprise can''t manufacture the drug due to special reasons, the holder of the new drug certificate may transfer the new drug technologies for a second time on the basis of the relevant certifications, such as the contract by which the original transferee abandons the manufacturing of that new drug etc. The SDA shall write off the registered number of approval for drugs of the said category of the original transferee pursuant to the provisions.

　　The enterprise accepting the new drug technologies transferred may not transfer such technologies for a second time.

　　Article 127 A drug manufacturing enterprise accepting the transferred new drug technologies must obtain the License for Drug Manufacturing and the certificate of the Criterions for the Quality Control of Drug Manufacturing. The new drug transferred shall fall within the manufacturing scope specified in the License for Drug Manufacturing and the certificate of the Criterions for the Quality Control of Drug Manufacturing of the transferee.

　　Article 128 When transferring the new drug manufacturing technologies, the holder of the new drug certificate shall sign a transfer contract with the transferee, and shall transfer all the technologies and materials to the transferee and direct the latter to manufacture, on a trial basis, 3 successive batches of qualified⁴⁷ products.

　　Article 129 With respect to a new drug jointly developed by several entities, the transfer of new drug technologies shall be proposed by the entities that jointly signed on the new drug certificate and a transfer contract shall be concluded.

　　Article 130 When transferring the new drug technologies, the holder of the new drug certificate and the transferee shall jointly file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the transferee is located, fill in the Supplementary Drug Application Form, and submit the relevant materials and enclose the transfer contract.

　　Article 131 After accepting an application for the transfer of new drug technologies, the drug administration of the province, autonomous region or municipality directly under the Central Government shall investigate the spot of trial manufacturing, manufacturing equipment, manufacturing of samples and inspection records of the transferee, select samples and notify the institute for drug control to make an inspection.

　　Article 132 The institute for drug control undertaking⁴⁸ the drug inspection shall finish the inspection within the prescribed time limit, produce the inspection report and submit it to the drug administration of the province, autonomous region or municipality directly under the Central Government which notified it to make the inspection.

　　Article 133 The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of the inspection report and relevant materials received and give opinions thereon, submit them to the SDA and notify the applicant of the examination opinions.

　　Article 134 The SDA shall make a comprehensive evaluation of the transfer of new drug technologies. If clinical study is needed, the Official Document on Clinical Study of Drugs shall be issued.

　　The applicant shall, after finishing the clinical study, submit the clinical study materials to the SDA.

　　Article 135 The SDA shall decide whether or not to approve the manufacturing by the form of Official Document on Supplementary Drug Applications. Drug approval certificate shall be issued if the requirements of the provisions are met, and the drug approval certificate already obtained by the transferor shall be written off.

　　Article 136 With respect to a drug within its monitoring period, the new drug technologies may not be transferred

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