Professional drug registration services

Service Overview

The drug registration services we provide are a comprehensive solution tailored for pharmaceutical companies, aimed at ensuring that every step of your drug's journey from research and development to market launch meets the strict requirements of the national drug regulatory authorities. Our professional team will work alongside you to ensure the safety, efficacy, and quality control standards of the drug, protecting patients from the dangers of non-compliant drugs.

Service Content

Drug registration strategy planning

Drug classification and registration type determination: Clarifying the category and suitable registration path for your drug, including new drugs, generic drugs, and imported drug registrations.

R&D funding and time management: Providing strategic planning for R&D funding input and review cycles based on your drug characteristics to reduce registration risks.

Pharmaceutical research and non-clinical research support

Pharmaceutical research: Covering drug synthesis processes, quality research, stability studies, etc., providing solid data support for the safety and efficacy of the drug.

Non-clinical research: Including pharmacology and toxicology studies, providing key data for preclinical safety assessment of the drug.
Clinical trial design and execution 
Clinical trial protocol development: Designing and executing clinical trials for corresponding phases based on drug registration classification and requirements.
Ethical compliance: Ensuring that clinical trials adhere to strict ethical standards and trial protocols to guarantee the legality and effectiveness of the trials.
Preparation of registration application materials 
Application forms and supporting documents: Preparing drug registration application forms and relevant supporting documents to ensure completeness and compliance of materials.
Research data integration: Integrating pharmaceutical research data, non-clinical research data, and clinical trial data to form a complete set of registration application materials.
Submission of application and review follow-up 
Application submission: Submitting registration application materials through NMPA's online service hall and tracking acceptance progress in real-time.
Review process management: Managing the entire process of formal review, technical review, and on-site inspection to ensure smooth review.
Administrative approval and post-registration supervision 
Approval decision response: Quickly responding based on NMPA's administrative approval decisions, providing professional rectification plans if needed.
Post-registration supervision: After obtaining the registration certificate, providing ongoing supervision services, including submission of reports on drug production sales, quality control, adverse reaction monitoring, etc.
 

Our Capabilities

Professional Knowledge:Our team consists of food regulation experts and industry consultants who have an in-depth understanding of food additive registration processes and regulatory requirements.
Efficient Processes:We have optimized the registration process to quickly respond to and handle various registration matters, shortening your product's time to market.
Successful Cases:We have numerous successful cases helping clients smoothly navigate the registration process to obtain food additive approval documents.
Customer Service:We provide one-on-one customer service to ensure that every question you have receives timely and professional answers.

Why Choose Us

One-stop Service:From consultation to registration, we provide one-stop services so you don't have to worry about complicated registration processes.
Professional Team:Our team members possess a strong industry background and professional knowledge to provide you with precise consulting services.
Cost-effectiveness:Through our professional services, you can avoid time and cost losses caused by insufficient material preparation or unfamiliarity with processes.
Continuous Support:We not only help you complete the registration but also provide subsequent supervision and management services to ensure your products remain compliant.

By choosing us, you will gain a trusted partner who helps your food additive business enter the market smoothly and efficiently. We look forward to working with you to create a future of food safety.

What is Drug Registration

'Drug registration' refers to the process where pharmaceutical companies submit a complete set of detailed materials regarding drug development to national drug regulatory authorities. After strict review and approval, they obtain an official 'Drug Approval Certificate.' Drug registration is an official threshold that all drugs must pass from R&D to market launch, ensuring that all marketed drugs meet safety, efficacy, and quality control standards to protect patients from non-compliant drugs.

'Challenges faced in drug registration mainly include: significant R&D funding investment, long review cycles, and strict review standards. To reduce risks, companies need to conduct strategic planning in advance, strengthen communication with regulatory authorities, and invest in compliance research. Even after obtaining market approval for a drug, pharmaceutical companies must continue monitoring the drug's performance, including adverse reaction reports and post-marketing studies, ensuring long-term safety and efficacy of marketed drugs.'

'Registration Types'

'New Drug Registration:''For innovative drugs with entirely new chemical structures, mechanisms of action or therapeutic uses, new drug registration is required. New drug registration typically requires rigorous clinical trials to demonstrate safety, efficacy, and quality controllability.'

'Generic Drug Registration:''Generic drugs refer to those that are identical in major active ingredients and excipients to original research drugs. Generic drug registration requires consistency evaluation with original research drugs regarding quality and efficacy to ensure similar safety and efficacy.'

'Imported Drug Registration:''Drugs produced overseas must undergo imported drug registration before being marketed in China. In addition to submitting relevant materials about the drugs themselves, imported drug registrations also require providing supporting documents issued by the regulatory authority in the country or region where the manufacturing enterprise is located.'

'Supplementary Application for Drugs:''When a marketing authorization holder makes changes to an approved drug's production process, quality standards, instructions for use or labels, they must submit a supplementary application for registration to NMPA.'

Preparation and Declaration Process for Registration

Preparation before application:

• Determine the drug classification and registration type:Clarify the category of the drug and the suitable registration type
• Conduct pharmaceutical research and non-clinical studies:Including drug synthesis processes, quality studies, stability studies, and pharmacology and toxicology studies, providing data support for the safety and efficacy of the drug.
• Conduct clinical trials:Based on the drug's registration classification and relevant requirements, conduct clinical trials at corresponding stages to evaluate the safety and efficacy of the drug in humans. Clinical trials must adhere to strict ethical standards and trial protocols.
• Prepare registration application materials:Generally includes drug registration application form, supporting documents, drug instructions, labels, pharmaceutical research data, non-clinical research data, clinical trial data, etc. Specific requirements vary based on registration type and drug characteristics.

Submit application:Submit the prepared registration application materials to NMPA through the online service hall or designated declaration channels. After submission, you can check the acceptance progress of the application in the system.

Acceptance and Review

• Formal review:NMPA conducts a formal review of the completeness and compliance of the application materials. Those that meet the requirements will be accepted; those that do not will be notified to correct within a specified time.
• Technical review:NMPA's professional review team conducts a detailed technical review of the application materials, including reviews of pharmaceutical, pharmacology and toxicology, clinical trials, etc. During the review process, applicants may be asked to provide additional materials or explanations for related issues.

On-site inspection:For certain drugs, especially innovative drugs or those with complex production processes, NMPA will organize on-site inspections to verify the production site, quality management system, etc., to ensure that the production process meets regulatory requirements and that quality is controllable.
Administrative approval:Based on the results of formal review, technical review, and on-site inspection, NMPA makes an administrative approval decision. If approved, a "Drug Approval Certificate" will be issued; if not approved, applicants can make corrections as required and reapply.
Post-registration supervision:After obtaining a registration certificate, drugs are still subject to NMPA supervision. The drug marketing authorization holder must submit reports on drug production sales, quality control, adverse reaction monitoring, etc., regularly according to relevant requirements to ensure drug quality and safety.

Basic process for drug development and market declaration

Drug R&D and testing:Including formulation development, laboratory testing, animal testing, and clinical trials.
Submit registration application:Drug registration usually begins with submitting a New Drug Application (NDA), which includes all research data and related materials for the drug.
Regulatory department review:The drug regulatory department conducts a formal review of submitted materials and data. A "Notice of Acceptance" is issued a few days later.
Expert review:The accepted materials are reviewed by experts from the National Medical Products Administration's Traditional Chinese Medicine Review Center to comprehensively assess the safety, efficacy, and stability of the production process of the drug.
Approval or rejection:Based on the review results, the regulatory department decides whether to approve the drug for market release.

Materials required for drug registration include several major parts

Pharmacology and toxicology data:Describes the mechanism of action of the drug, its efficacy, and potential toxic side effects.
Clinical trial data:Provides design, execution, statistical analysis, and conclusions of clinical trials.
Production process data:Includes production processes, quality control standards, and product specifications.
Drug labels and instructions:Clearly state indications for use, dosage instructions, warnings, and storage conditions.