Main Business items
The business is divided into: registration of imported domestic API, registration of medicinal auxiliary materials, registration of medical devices, registration of food additives, registration of new food raw materials, registration of health food, registration of cosmetic raw materials
The service content
Record/registration of new cosmetic ingredients
1. Scope of application
New cosmetic raw materials produced and operated within the territory of the People's Republic of China
2. Policies and regulations
1. Regulations on Supervision and Administration of Cosmetics (Order No.727th of the State Council of the People's Republic of China)
Content link: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20200629190501801.html
2. Measures for the Administration of Cosmetic Registration
Content link: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20210112114521164.html
3. Regulations on the Administration of Registration and Filing Materials of New Cosmetic Raw Materials
Content link: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210304140454159.html
4. Regulations on the Administration of Cosmetic Registration and Filing Data
Content link: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210304140747119.html
3. Information requirements
l Application form for record/registration of new cosmetic raw material
l New raw material development report
l Research materials on the preparation process, stability and quality control standards of new raw materials
l New raw material safety assessment data
4. Service content
l Cosmetic raw material quality and safety information submission service
l Test supervision services for physicochemical/toxicological/efficacy of new cosmetic raw materials
l Safety assessment service for new raw materials of cosmetics
lTracking the whole process of filing/registration of new cosmetics raw materials
I. Registration of imported and domestic apis, pharmaceutical excipients and pharmaceutical packaging materials
1. Legal basis
Drug Administration Law of the People's Republic of China, Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, And Drug Registration Administration Measures
Notice of the General Administration of The People's Republic of China on The Adjustment of Matters concerning the Review and Approval of API, Pharmaceutical Auxiliary Materials and Pharmaceutical Packaging Materials (No. 146 of 2017)
Notice of the State Food and Drug Administration on Further Improving the Examination, Approval and Supervision of Drug Association (No. 56 of 2019)
2. Scope of application
Auxiliary materials developed, produced, imported and used in the People's Republic of China.
3. Registration information requirements
It shall comply with the requirements of Appendix 1 in the announcement of the General Administration on the adjustment of the review and approval items of apis, pharmaceutical excipients and pharmaceutical packaging materials.
4. Type of registration
Import accessories registration, update, annual report.
Domestic accessories registration, update, annual report.
5. Acceptance organization
Center for Drug Evaluation (CDE), National Medical Products Administration
II. import, domestic auxiliary materials registration target
Register for customer's import or domestic accessories to provide reliable registered consulting services, the review in connection with the drug product, help customers products smoothly through the technical evaluation, make preparations of enterprise to obtain the drug import registration certificate/the pharmaceutical products registration certificate or the drug approval number, achieving the CDE of complementary makings registration number "by technology review" tag, namely "A".
III. Service content
1. Provide registration agent service for imported auxiliary materials.
2. Provide the declaration materials for compiling the outline.
3. Analyzed the gap of the registration data, estimated the risks, proposed correction measures, and made the registration auxiliary materials pass the technical review smoothly.
4. Review, translate, improve, compile and submit registration materials.
5. Registration inspection application, sample submission, tracking and problem solving.
6. Follow up the whole process of auxiliary materials registration, send supplementary questions and reply materials for submission.
7. Update auxiliary materials registration data, including major change, medium change, minor change and basic information change.
8. Technology transfer of auxiliary materials registration data.
9. Submission of the annual report of registered auxiliary materials.
IIII. Import and domestic auxiliary materials registration process
GMP compliance and certification
Provide a package of services from system establishment, improvement, audit, simulation inspection to official certification inspection. Include:
(1) On-site inspection of NMPA for domestic GMP certified foreign enterprises
(2) International GMP certification
Us FDA, EU, Australia, WHO, PIC/S GMP certification
GMP non-conformance /483/ Warning letter rectification
(3) GMP professional translation
GMP inspection Chinese and English interpretation/translation
GMP inspection Korean and Chinese, Japanese and Chinese interpretation/translation
(4) GMP Project
Planning and design of new/rebuilt plant (workshop) to comply with GMP
(5) The r&d laboratory system complies with the regulations
Establishment of R & D system/guidance of defect rectification/audit, etc
Verification test consultation
(1) Equipment/instrument confirmation service (2) Process/method/system verification service (3) Computerized system verification service
(1) Registration of imported/domestic medicines
Registration of imported/domestic preparations
Import/domestic API registration
Registration of imported/domestic pharmaceutical accessories
Registration of imported/domestic pharmaceutical packaging materials
(2) Domestic drug research and development guidance services
(3) Registration of imported/domestic health food
(4) Registration of imported/domestic cosmetics
Import/domestic cosmetics registration/administrative license application
Registration of new ingredients for cosmetics
The international registration
Eu Drug Registration (MA Application)
Application for EU CEP/COS
Eu Registration of Traditional Herbal Medicines
Australian Drug Registration
WHO supplier pre-certification
American DMF document making and archiving
FDA factory registration and NDC application
SMF file making
ECTD format conversion
(2) Health food
Notification of American Dietary Supplement Certification with New Ingredients (NDI)
United States Food Additive Certification
European Certification of food Supplements/Additives
Eu Novel Food and ingredient Certification
Drug Marketing License Certificate Holder (MAH) trusteeship service
Consultant in pharmaceutical affairs
Enrprise perennial pharmaceutical administration regulations consultant
Technology transfer for pharmaceutical products
Medical Device Registration
CFDA: in accordance with the Regulations on Supervision and Administration of Medical Devices and CFDA Laws No. 4 and No. 7, provide one-stop technical guidance on the safety and effectiveness of the medical devices to be marketed and used by you, so as to facilitate the approval of their marketing, sales and use by CFDA.
The State conducts classified management of medical devices according to the degree of risk (* For specific classification, please refer to Medical Device Classification Rules (Order No. 15 of China Food and Drug Administration))
The first category is low risk, the implementation of routine management can ensure its safe and effective medical devices.
The second category is medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness.
The third category is medical devices that are of high risk and require strict control and management with special measures to ensure their safety and effectiveness.
Medical device products adopt a filing/registration classification management system. The first category of medical device products is applicable to product registration, while the second and third categories are applicable to product registration.
Domestic production of products
The archivists of category I medical device products shall submit the archival materials to the food and drug regulatory department of the municipal people's government divided into districts where they are located. Under the premise that the materials meet the requirements, the time limit for the processing shall generally be no more than 5 working days (there are differences among the administrative departments of different regions).
The second category of medical device product registration shall be submitted by the registrant to the food and drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the registrant is located. The accepting department shall make an examination and approval decision within 20 working days after receiving the technical review opinions.
For the registration of category III medical devices, the registrant shall submit the registration application materials to the food and drug regulatory department under the State Council. The accepting department shall make an examination and approval decision within 20 working days after receiving the technical review opinions.
Products imported from abroad
Imported products for the record/registered need to submit the materials to the food and drug supervision and administration department under the State Council, in addition to the corresponding record/registered material, at the same time also need to submit the country (region) permitted by the competent department of the medical equipment sale of documents, and by its representative offices located in the territory of China or designated within the territory of the enterprise as a legal person as agent.
The production of category I medical devices shall be subject to archival filing management: the production enterprise shall file with the food and drug regulatory department of the municipal people's government divided into districts where it is located and submit the certifying data that it meets the requirements.
The production license administration is applicable to the production of medical devices of Category II and III: the production enterprise shall apply to the food and drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located for production license and submit the certifying data that it meets the requirements. If the requirements are met after examination, a production license for medical devices shall be issued, and the period of validity shall be 5 years.
There is no need for filing or business license for class I medical devices
The second category of medical devices shall be subject to archival filing management: the trading enterprise shall file with the food and drug regulatory department of the municipal people's government divided into districts where it is located and submit the certifying data that it meets the requirements.
The production of category III medical devices shall be subject to the management of business license: the trading enterprise shall apply for the business license to the food and drug regulatory department of the municipal people's government divided into districts where it is located and submit the certification materials that meet the requirements. Upon examination and approval, a medical device business license shall be issued, and the period of validity shall be 5 years.
Open meeting & Custom training
1. GMP compliance and certification
2. Verification test consultation
3. Domestic registered
4. The international registration
5. Drug Marketing License Certificate Holder (MAH) trusteeship service
6. Consultant in pharmaceutical affairs
7. Open meeting & Custom training
Beijing：D10,4th.floor,Block A, Borui Building,No.26 North Rd.of East 3rd. Ring,
Chaoyang District,Beijing,100026 P.R.C
Shanghai：Room D-308 Zhongyi International Square,
No.800 Puxing Road, Minhang District, Shanghai, 201114 P,R.C
Tel: +86-021-3478 3993
Guangzhou：Room 612, 6th Floor, 445 Xingnan Building, Panyu District, Guangzhou
Tel: 400 660 1329
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