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Information Details
Introduction to Registration of Pharmaceutical Excipients
Release time:
2020-01-08 09:04
Introduction to the registration of imported and domestic raw materials in 1.
1. Legal basis
Announcement of the State Food and Drug Administration on Further Improving Matters Related to Drug Related Review, Approval and Supervision (No. 56 of 2019) Document No. 134 of 2016-Announcement of the General Administration on Matters Related to Drug Package Materials and Drug Related Review and Approval (No. 134 of 2016); Clearly cancel the separate approval of excipients
155 of 2016-Notice of the General Administration on Issuing the Requirements for Application Data of Pharmaceutical Accessories for Drug Package Materials (for Trial Implementation); Requirements for Compilation of Pharmaceutical Supplements
146 No. 2017-Announcement on Adjusting the Review and Approval of Raw Materials, Pharmaceutical Accessories and Pharmaceutical Package Materials (146 No. 2017); Supplementary document No. 134
2018-CDE Notice on Publicly Soliciting Opinions on "Requirements for Registration Materials of Pharmaceutical Excipients (Draft for Comments)" and "Requirements for Registration Materials of Pharmaceutical Package Materials (Draft for Comments);
Document No. 56 of 2019-Drug Supplementary Data Requirements; Replaced Document No. 155. 2019.8.15 Effective
2. Scope of application
Excipients developed, produced, imported and used in the People's Republic of China.
3. Registration Information Requirements
It shall comply with the requirements of Annex 1 in the announcement of the General Administration on the adjustment of the review and approval of raw materials, pharmaceutical excipients and drug packaging materials.
4. Registration Type
Import accessories registration, update, annual report.
Domestic accessories registration, update, annual report.
5. Receiving institutions
Center for Drug Evaluation (CDE), State Drug Administration
Registration target of imported and domestic accessories in 2.
Provide reliable registration consulting services for customers' registration of imported or domestic excipients, assist customers' products to successfully pass the technical review when reviewing related to preparation products, so that preparation enterprises can obtain the "Import Drug Registration Certificate"/"Pharmaceutical Product Registration Certificate" or drug approval number, thus realizing CDE to mark the excipient registration number "through technical review", I .e. "A" status.
3. service content
1. Provide registered agent services for imported accessories.
2. Provide an outline for the preparation of the declaration information.
3. Gap analysis of the registration data, estimate the risk, and propose corrective measures to make the registration accessories pass the technical review smoothly.
4. Review, translation, perfection, compilation and submission of registration materials.
5. Registration inspection application, sample delivery, tracking and problem solving.
6. Follow up the whole process of auxiliary materials registration, send supplementary questions and answer and submit supplementary reply materials.
7. Update of auxiliary materials registration data, including major changes, medium changes, minor changes and basic information changes.
8. Technology transfer of auxiliary materials registration data.
9. Submission of the annual report of registered excipients.
4. Imported and Domestic Accessories Registration Process
1. Fill in the "Application and Registration Form for Raw Materials, Pharmaceutical Accessories and Drug Package Materials"
2. Submission of registration information to CDE
3. Registration data review, platform publicity registration number, status "I", query address http://www.cde.org.cn/yfb.do?method=main
4. Technical review associated with the product
5. Mark the registration number with the status "A"
5. FAQ
1. What are the specific requirements for CD-ROMs when submitting registration information?
Answer: The following 2 requirements shall be met when submitting the CD:
(1) The CD should be loaded into the CD hard case and separately into the document bag. The cover of the CD box shall indicate the following documents: registration data of bulk drugs/pharmaceutical excipients/drug packaging materials, and relevant information such as registration number, version number, product name, reporting unit (official seal of reporting unit shall be affixed).
(2) Please submit the application materials with the suffix of. docx generated by Word 2007 or above.
How is the annual report submitted?
Answer: The published raw and auxiliary package products need to upload an annual report, and an annual report will be uploaded in the first quarter of each week from the date when the registration number is published in the drug evaluation center. In the window of CDE applicant, click the left directory "raw and auxiliary package" → "annual report", the list of annual reports will appear on the page, click the "create" button corresponding to the registration number, and the system will open a new page to display the report upload page. Select the file to upload and click Submit.
3. Can drug packaging materials and pharmaceutical excipients be declared in connection with drug supplement applications?
Answer: When a drug registration applicant submits supplementary application items 1, 6 and 10 in accordance with Annex 4 of the Measures for the Administration of Drug Registration, or submits supplementary application item 12 in accordance with the Provisions on the Administration of Registration of Drug Technology Transfer (State Food and Drug Administration Note [2009] No. 518), relevant drug packaging materials and pharmaceutical excipients may be applied in connection with the above supplementary application.
4. What are the pharmaceutical excipients that may not be included in the associated review and approval?
Answer:(1) flavor (sweetener): such as sucrose, single syrup, mannitol, sorbitol, saccharin sodium, aspartame, sucralose, stevioside, glucose, xylitol, maltitol and so on. This variety is limited to use as a flavoring agent (sweetener) in preparations.
(2) flavors and spices: such as orange flavor, banana flavor, vanillin, etc. The implementation of food standards should comply with the current version of GB 2760 "National Food Safety Standards for the Use of Food Additives", GB 30616 "National Food Safety Standards for Food Flavors" and GB 29938 "National Food Safety Standards for Food Flavors General Rules" and other relevant requirements.
(3) Pigment (coloring agent): such as iron oxide, plant carbon black, cochineal, etc. The implementation of food standards shall comply with the current version of GB 2760 "National Food Safety Standards for the Use of Food Additives" and other relevant requirements.
(4)pH regulators (including pH regulators used in injections): such as malic acid, fumaric acid, acetic acid, sodium acetate, citric acid (sodium, potassium salt), tartaric acid, sodium hydroxide, concentrated ammonia solution, hydrochloric acid, sulfuric acid, phosphoric acid, lactic acid, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, disodium hydrogen phosphate, sodium dihydrogen phosphate, etc.
(5) Inorganic salts (including inorganic salts used in injections) that are only used as excipients, simple preparation process and stable physical and chemical properties: such as calcium carbonate, sodium carbonate, potassium chloride, calcium chloride, magnesium chloride, calcium phosphate, calcium hydrogen phosphate, calcium sulfate, sodium bicarbonate, etc.
(6) Benzene-free ink for oral preparation printing.
The above-mentioned pharmaceutical excipients, which have been included in the current edition of the Chinese Pharmacopoeia, shall meet the requirements of the current edition of the Chinese Pharmacopoeia. What is not included in the current edition of the Chinese Pharmacopoeia shall meet the requirements of the national food standards or the current edition of USP/NF, EP, BP and JP Pharmacopoeia standards. Other excipients shall meet the medicinal requirements.
When applying for drug registration, the drug registration applicant shall at least provide the information of the manufacturer of pharmaceutical excipients, basic product information, production process information, product quality standards, inspection reports and other relevant materials in the drug registration application materials. The above-mentioned excipients will not be issued an approval number after the completion of the associated review.
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