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   

Domestic registered

(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

(1) Drugs

• 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.

 Product

•  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.

  Production

• 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.

  Management

•  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

Our services

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