Chapter XII Application and Examination & Approval of Repackaging of Imported Drugs

　　Article 137 Repackaging of imported drugs shall refer to changing big drug packages into small ones after the final preparations are finished overseas, or making external packaging, placing specifications¹ and affixing² labels etc for drugs of which the internal packaging has been finished.

　　Article 138 The following requirements shall be met for the application for repackaging of imported rugs:

　　（1） The drug applying for repackaging has already obtained the Registration³ Certificate of Imported Drugs or the Registration License⁴ for Pharmaceutical⁵ Products;

　　（2） The drug shall fall within a category that has not yet been manufactured within China, or a category of which the manufacturing within China can''t meet the clinical needs;

　　（3） The same category manufactured by the same drug manufacturer shall be repackaged by one drug manufacturing enterprise, and the period shall not exceed 5 years generally.

　　Article 139 An overseas drug manufacturer shall sign a contract on repackaging of imported drugs with the domestic drug manufacturing enterprise, and fill in the Supplementary⁶ Drug Application Form.

　　Article 140 A drug manufacturing enterprise accepting the repackaging work must hold the License for Drug Manufacturing and have the certificate of Criterions for the Quality Control of Drug Manufacturing; the drug to be repackaged shall fall within the manufacturing scope specified⁷ in the License for Drug Manufacturing and the certificate of Criterions for the Quality Control of Drug Manufacturing of the trustee.

　　Article 141 The trustee shall file the application for drug repackaging with the drug administration of the province, autonomous⁸ region or municipality directly under the Central Government where it is located, submit the Supplementary Drug Application Form filled in by the trustor, and submit the relevant materials, samples and the trust contract etc. The drug administration of the province, autonomous region or municipality directly under the Central Government shall finish the examination within the prescribed time limit and submit the application materials to the SDA.

　　Article 142 The SDA shall examine the submitted materials and decide on whether to approve the repackaging by the form of Official Document on Supplementary Drug Applications. If the requirements of the provisions are met, the application shall be approved and the registered number of approval for drugs shall be issued.

　　Article 143 An application for drug repackaging shall be filed 1 year earlier than the expiration⁹ of the valid¹⁰ term of the Registration Certificate of Imported Drugs or Registration Certificate of Pharmaceutical Products of the drug.

　　Article 144 Registration standards for imported drugs shall be implemented¹¹ for the drugs to be repackaged.

　　Article 145 The packaging, labels, and specifications of the drugs repackaged must meet the requirements of the relevant provisions of the SDA, and at the same time the registered number of approval for drug repackaging and the registration certificate number of imported drugs or registration certificate number of pharmaceutical products shall also be indicated.

　　Article 146 The import inspection¹² of overseas preparations in large packages shall follow the relevant provisions of the SDA. The same drug standard shall be implemented in the inspection of repackaged products and the import inspection. The first 3 batches¹³ of products repackaged shall be sent to the institute for drug control designated by the SDA, and shall pass the inspection before they can be marketed.

　　Article 147 The overseas drug manufacturer supplying the drugs shall be responsible for the quality of the repackaged drugs, if any quality problem arises, the SDA may cancel the registered number of approval of the repackaged drugs, and may cancel the Registration Certificate of Imported Drugs or Registration Certificate of Pharmaceutical Products according to the provisions of Article 42 of the Drug Administration Law.

　　Article 148 If the drugs are packaged within China upon the entrustment¹⁵ by overseas drug manufacturers and by adopting the preparations and packaging materials provided thereby¹⁶, but not marketed or used within China, the domestic drug manufacturing enterprise making the packaging shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, it may package the drugs only after being approved, and it shall put that on record with the SDA, but the registered number of approval for drugs shall not be issued.

　　Chapter XIII Administration of Drug Registration Inspection

　　Article 149 Drug registration inspection must be conducted in the application for drug registration. Drug registration inspection shall include sample inspection and drug standard review conducted on the drugs applying for registration.

　　Sample inspection shall refer to the inspection conducted by the institute for drug control on the samples pursuant to the drug standard supplied by the applicant¹⁷.

　　Drug standard review shall refer to the lab inspection and examination conducted by the institute for drug control with respect to the feasibility, scientificity of the inspection methods specified in the drug standard supplied and whether the indications set by the standard can control the drug quality etc.

　　Article 150 Drug registration inspection shall be undertaken by an institute for drug control of the province, autonomous region or municipality directly under the Central Government. Registration inspection of imported drugs shall be carried out by the National Institute for the Control of Pharmaceutical and Biological Products.

　　Article 151 Registration inspection of the following drugs shall be undertaken by the National Institute for the Control of Pharmaceutical and Biological Products or an institute for drug control designated by it:

　　（1） Drugs listed in Subparagraphs 1） and 2） of Article 49 of these Measures;

　　（2） Biological products;

　　（3） Other drugs provided for by the SDA.

　　Article 152 For drugs meeting the provisions of Article 49 of these Measures, the institute for drug control shall give priority to them in the arrangement of inspection and drug standard review.

　　Article 153 An institute undertaking¹⁸ the drug registration inspection shall, pursuant to the requirements of the Criterions on the Administration of Quality Control of the Laboratories of Institutes for Drug Control and the requirements of national metrological authentication¹⁹, have the personnel and equipment accommodating to the tasks of drug registration inspection, thus to meet the quality guarantee system and technical requirements of drug registration inspection.

　　Article 154 The applicant shall provide the institute for drug control with the relevant materials needed, submit the samples or assist it in the selecting of samples for inspection use, and provide the standard materials for inspection use. Quantity of the samples shall be 3 times of that used in the inspection, and the manufacturing check records of the corresponding batches shall also be included with respect to biological products.

　　Article 155 With respect to an application for manufacturing of the drug with existing state standard, the institute for drug control shall, upon receipt of the samples, make the inspection pursuant to the state standard, and make a comprehensive analysis of the change of quality indications resulted from the change of techniques, and shall ask the applicant to work out the corresponding quality indications if necessary to ensure the controllability of the drug quality.

　　Article 156 With respect to the review of standard for a new drug, the institute for drug control shall, apart from making inspection over the samples, give review opinions on the drug standard, inspection items and methods for the inspected drug pursuant to the study data of the drug, the drug standards for drugs of the same category home and abroad and the relevant requirements of the state.

　　The institute shall inform the applicant, if necessary, before giving the review opinions. If the applicant has any objections, it shall present its complaint to the institute within 10 days. If the institute disagrees with the complaint of the applicant, it shall submit its review opinions and the applicant''s complaint to the SDA together, and shall send a copy to the applicant and the drug administration of the province, autonomous region or municipality directly under the Central Government which sent the notice on drug registration inspection.

　　Article 157 With respect to the reformulation of a drug standard, the applicant may not entrust¹⁴ the institute for drug control that gave the opinions to carry out the study of the drug; neither may that institute accept such an entrustment.

　　Chapter IXV Administration of the Drug Registration Standards

　　Section I Basic Requirements

　　Article 158 State drug standards shall refer to the technical requirements for quality indications, inspection methods and manufacturing techniques etc set forth²⁰ by the state in order to guarantee the drug quality, including the Drug Code of the People''s Republic of China, the drug registration standards and other drug standards promulgated²² by the SDA.

　　Drug registration standards shall refer to the standards by which the SDA approve certain drugs to the applicant, and which the drug manufacturing enterprises of the said drugs must carry out.

　　Article 159 The items of a drug registration standard and the setting of the inspection methods thereof shall conform to the technical guiding principles and the principles and detailed²³ rules for drawing up the state drug standards promulgated by the SDA.

　　Article 160 The applicant shall, on the premise²⁴ that the quality of the raw materials and the manufacturing techniques are steady, select the representative samples to conduct the study of a standard.

　　Section II Formalization of Tentative Drug Standards

　　Article 161 After the manufacturing of a new drug has been approved, the drug standard thereof shall be a tentative standard, and the tentative period shall be 2 years. For other drugs, if further investigation²⁵ shall be carried out over the manufacturing techniques and the stability of the product quality after the manufacturing has been approved, the drug standards thereof may also be approved as tentative standards.

　　Article 162 In the manufacturing of a drug with tentative standard, the drug manufacturing enterprise shall, 3 months before the expiration of the tentative period, file an application of formalization of the standard with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located pursuant to the requirements for supplementary application, and shall submit the quality assessment²⁶ materials of the drug within the tentative period of the standard, as well as the opinions on revision of the tentative standard.

　　Article 163 The drug administration of the province, autonomous region or municipality directly under the Central Government shall finish the examination within 10 days from receiving the application for formalization of the tentative drug standard, and shall submit the examination opinions and the relevant materials to the SDA.

　　Article 164 The SDA shall organize the State Drug Code Committee to conduct a comprehensive examination of the tentative drug standard.

　　The State Drug Code Committee shall, according to the implementation²⁷ of the drug standard during the tentative period, the standards for the relevant products home and abroad and the relevant state requirements, give opinions on whether or not the said drug standard needs to be reviewed. If the standard needs to be reviewed, the relevant institutes for drug control shall be organized to carry out the review and inspection of the tentative drug standard.

　　Article 165 Inspection and review for the formalization of tentative standards for drugs of the same category manufactured by several drug manufacturing enterprises shall be carried out by the National Institute for the Control of Pharmaceutical and Biological Products or the institute for drug control designated by the SDA.

　　Article 166 With respect to the tentative standards for drugs of the same category formalized upon applications by different applicants²⁸, those approved later shall not be lower than those approved earlier, and the necessary inspection items of relevant materials etc shall be added in light of their respective technique characteristics.

　　Article 167 If an applicant needs to make supplementary trials or improve the materials, it shall finish the supplement or improvement within 50 days after receiving the notice on standard review and inspection, and shall submit them to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located.

　　Article 168 The SDA shall make an examination of the materials submitted by the State Drug Code Committee, and approve the formalization of a tentative drug standard by the form of Promulgation²⁹ Document of State Drug Standards.

　　Article 169 With respect to drugs of the same category of which the tentative standard periods expire on different dates, the formalization of those expiring earlier shall be processed earlier. And for the drugs of which the tentative standard periods haven''t expired, the State Drug Code Committee shall notify the applicants to file applications for formalization in advance with the drug administrations of the provinces, autonomous regions and municipalities directly under the Central Government.

　　Article 170 If an applicant fails to file the application for formalization upon the expiration of the tentative standard period or if the tentative standard fails to conform to the requirements for formalization, the SDA shall cancel that standard and the registered number of approval for the drugs manufactured on the basis of such tentative standard. During the period when application for formalization of a tentative standard is processed, the drug manufacturing enterprise shall manufacture drugs pursuant to the tentative standard.

　　Section III Administration of Drug-relating Standard Materials

　　Article 171 Drug-relating standard materials shall refer to the materials that are for experiment use in the physical and chemical testing and biological methods specified in the drug standards, that are with determinable quantity and are used in the adjusting of equipment, evaluation³⁰ of measuring methods or providing evaluations³¹ to the drugs for experiment, including standard articles, comparison articles, comparison medicine materials and reference articles.

　　Article 172 The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for demarcating and administering the state drug-relating standard materials, either may it organize the institutes for drug control, institutions for drug study or drug manufacturing enterprises of the relevant provinces, autonomous regions and municipalities directly under the Central Government to assist in the demarcating.

　　Article 173 When applying for the manufacturing of a new drug, the applicant shall submit the standard materials and raw materials for preparation of such drug to the National Institute for the Control of Pharmaceutical and Biological Products, and shall submit the study materials of the relevant standard materials.

　　Article 174 For the standard materials demarcated, the National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for conducting a comprehensive technical examination of the selection of raw materials, the preparing methods, the demarcating methods, the demarcation results, the accuracy of fixed³² values, the metrological tracebility, the stability, and the conditions for repackaging and packaging etc, and shall make the conclusion whether or not the materials may be used as state drug-relating standard materials.

　　Chapter XV Provisions on Time Limits in Drug Registration

　　Article 175 Time limits in drug registration shall refer to the maximum time periods allowed for finishing the examination, inspection and supplementing of materials relating to drug registration.

　　Article 176 The drug administration of a province, autonomous region or municipality directly under the Central Government shall, upon receiving an application submitted by the applicant, organize within 5 days and finish within 30 days the on-spot investigation, sample selection and notification to the institute for drug control on making inspection over the samples, and shall submit the examination opinions and investigation report, together with the materials submitted by the applicant, to the SDA, and notify the applicant of the examination opinions at the same time.

　　Article 177 After receiving the notification on inspection and the samples, the institute for drug control shall finish the inspection within 30 days and produce the examination report.

　　For special drugs and vaccine³³ products, the inspection may be finished within 60 days.

　　Article 178 If the inspection over samples and review of drug standard are needed, an institute for drug control shall finish the inspection and the review within 60 days.

　　For special drugs and vaccine products, the inspection and review may be finished within 90 days.

　　Article 179 The SDA shall, after receiving the materials submitted by the drug administration of the province, autonomous region or municipality directly under the Central Government, finish the acceptance examination within 5 days and decide on whether or not to accept the application.

　　Article 180 With respect to an application for registration of imported drugs, the SDA shall finish the acceptance examination within 30 days, and notify the National Institute for the Control of Pharmaceutical and Biological Products to organize the inspection.

　　Article 181 The National Institute for the Control of Pharmaceutical and Biological Products shall, after receiving the materials and samples, assign the relevant institute for drug control to conduct the inspection within 5 days.

　　Article 182 The institute for drug control undertaking the inspection over imported drugs shall, after receiving the materials, samples and relevant standard materials, finish the inspection within 60 days and send the inspection report to the National Institute for the Control of Pharmaceutical and Biological Products.

　　Article 183 The National Institute for the Control of Pharmaceutical and Biological Products shall, after receiving the reviewed standard for imported drugs, organize the experts to make a technical examination within 20 days, and may conduct review again with respect to the specific items according to the examination opinions.

　　Article 184 When handling the applications for drug registration, the SDA shall observe the following provisions on time limits for technical examination:

　　（1） For clinical study of new drugs: within 120 days; for categories meeting the provisions of Article 49 of these Measures: within 100 days.

　　（2） For manufacturing of new drugs: within 120 days; for categories meeting the provisions of Article 49 of these Measures: within 100 days.

　　（3） For applications for drugs with existing state standards: within 80 days.

　　The time limits for technical examination of the application for import drug registration shall also observe the above provisions.

　　Article 185 When the SDA makes the technical examination for a drug registration application, if it is needed for the applicant to supplement materials, a notice on supplementing materials shall be issued once off.

　　The applicant shall finish supplementing the materials once off within 4 months pursuant to the requirements of the notice; for failure to supplement the materials within the prescribed time limit, the application shall be returned.

　　Article 186 If the applicant has any objections against the notice on supplementing materials, it may present its opinions within the prescribed time limit. If it still has objections, it may file written opinions with the SDA, explain the reasons and provide the technical materials and scientific basis, and the SDA shall make a decision after examination.

　　Article 187 With respect to an application that has been returned, if the applicant supplements and improves the relevant experiments or materials, and the provisions of these Measures on monitoring periods are met, the application may be filed again pursuant to the original procedures within 6 months after the returning of it.

　　Article 188 The SDA shall, after receiving the materials supplemented, finish the technical examination within no more than one third of the original time period allowed; for those meeting the provisions of Article 49 of these Measures, the technical examination shall be finished within no more than one fourth of the original time period allowed.

　　Article 189 The SDA shall finish the examination and approval within 40 days after finishing the technical examination; for categories meeting the provisions of Article 49 of these Measures, the examination and approval shall be finished within 20 days.

　　For the supplementary drug applications subject to the approval of the SDA, the SDA shall finish the examination and approval within 40 days; where technical examination is needed, the technical examination shall be finished within 60 days.

　　Article 190 The State Drug Code Committee shall finish the examination and decision on formalization of tentative drug standard within 60 days. An institute undertaking the task of standard review and inspection shall finish the review and inspection within 60 days, and send the review opinions and inspection report to the State Drug Code Committee. For special drugs and vaccine products, the period shall not exceed 90 days generally. And the review and inspection for formalization of the tentative standards for drugs of the same category manufactured by several drug manufacturing enterprises shall be finished within 80 days.

　　Article 191 Time limits provided for in these Measures shall be observed in the work of drug registration as a general principle. In case of special circumstances, the time period may be appropriately extended upon the approval by the SDA.

　　Chapter XVI Re-examination

　　Article 192 If the applicant has any objections against the decision made by the SDA on not granting the approval, it may file an application for re-examination with the SDA within 10 days and explain the reasons for re-examination.

　　The matters applying for re-examination shall be limited to those included in the original application.

　　Article 193 The SDA shall make the re-examination decision within 50 days from receiving the application for re-examination. If the original decision of not granting the approval is cancelled, the corresponding drug approval certifications shall be issued; if the original decision is sustained, the SDA will no longer accept any application for re-examination filed for a second time.

　　Article 194 If it is needed to conduct a technical examination for the application for re-examination, the SDA shall organize the relevant professionals to carry it out pursuant to the original application time limit.

　　Chapter XVII Penalty Provisions

　　Article 195 If an applicant submits false application materials and drug samples when applying for clinical study, the SDA will not approve the clinical study of the said drug and will give a warning to the applicant; if the clinical study has been approved, the official document approving the clinical study of the said drug shall be cancelled, and a fine of RMB 10,000 to 30,000 shall be imposed. If the circumstances are serious, the application for clinical trial of that drug filed by the said applicant will not be accepted within 3 years.

　　The SDA shall set up and promulgate²¹ the record of bad deeds of the applicants that submit false materials and samples.

　　Article 196 If an applicant submits false application materials and samples for drug registration when applying for the manufacturing or import of drugs, the SDA shall not approve that application and shall give a warning to the applicant; if the manufacturing or import has been approved, the drug approval certifications shall be cancelled, any application filed by that applicant will not be accepted within 5 years, and a fine of RMB 10,000 to 30,000 shall be imposed.

　　The SDA shall set up and promulgate the record of bad deeds of the applicants that submit false materials and samples.

　　Article 197 If the License for Drug Manufacturing of a drug manufacturing enterprise has been revoked³⁴, the registered number of approval for drugs held by that enterprise shall be invalidated automatically, and be written off by the SDA.

　　Article 198 If the Criterions for the Quality Control of Non-clinical Study of Drugs or the Criterions for the Quality Control of Clinical Trial of Drugs are not implemented in drug registration pursuant to the provisions, the offender³⁵ shall be punished according to Article 79 of the Drug Administration Law.

　　Article 199 If an institute for drug control produces false inspection report when it undertakes the drug inspection needed in the examination and approval of drugs, it shall be punished according to Article 87 of the Drug Administration Law.

　　Article 200 If it is needed to make an experiment on the drug for a second time according to Article 22 of these Measures and the applicant refuses, the SDA will give a warning to it and order it to correct, if the applicant refuses to correct, it will be deprived of its qualification for applying for registration of drugs of such category.

　　Chapter XVIII Supplementary Provisions

　　Article 201 Days as used in the work time limits in these Measures shall refer to workdays, not including statutory holidays.

　　Article 202 With respect to Chinese medicine materials, the crude slices of Chinese medicine, and imported Chinese medicine materials that are subject to the administration by registered number of approval, the provisions on the administration of registration shall be formulated³⁶ by the SDA separately.

　　Article 203 Administration of registration of biological, microbe, immunity³⁷ and nucleic acid external diagnostic reagents shall follow the measures for the administration of registration of biological external diagnostic reagents promulgated by the SDA.

　　Article 204 Measures for the administration of the packaging materials, containers and supplementary materials directly contacting the drugs shall be formulated by the SDA separately.

　　Article 205 Provisions on the administration of the packaging, labels and specifications of drugs, as well as the commodity names of drugs shall be formulated by the SDA separately.

　　Article 206 Applications for registration of narcotics³⁸, psychotropics substances, toxic³⁹ drugs for medical use and radioactive drugs shall, apart from following the provisions of these Measures, meet the relevant state provisions.

　　Article 207 Those applying for drug registration shall pay the registration fees pursuant to the provisions.

　　Article 208 These Measures shall enter into force on December 1, 2002. The Measures for the Examination and Approval of New Drugs, Measures for the Examination and Approval of New Biological Products, Provisions on New Drugs Protection and Technology Transfer, Measures for the Examination and Approval of Imitated Drugs and Measures for the Examination and Approval of Imported Drugs promulgated by the SDA on April 22, 1999 shall be nullified at the same time

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