Service Overview

Our raw and auxiliary material registration service focuses on providing comprehensive technical support and compliance services for pharmaceutical manufacturing enterprises, ensuring that the active pharmaceutical ingredients, excipients, and packaging materials used meet the quality standards and regulatory requirements of the National Medical Products Administration (NMPA). Our services cover the entire process from registration consultation to change management, aiming to ensure the safety and efficacy of drugs while promoting the market entry of new drugs and strengthening the regulation of the entire lifecycle of pharmaceuticals.

Service Content

Registration Consultation and Support

• Registration Procedure Guidance: We provide detailed guidance on the registration procedure, including process validation, product self-inspection or entrusted inspection, and preparation of application materials.
• Regulatory Evolution Interpretation: Interpret the regulatory evolution of raw and auxiliary material supervision to ensure that your registration work keeps pace with the times and complies with new legal and regulatory requirements.

Preparation of Registration Materials

• Technical Document Preparation: Including product specifications, production process flowcharts, quality management system documents, etc., detailing the structure, performance, and quality control measures of the product.
• Characteristic Identification and Quality Control: Researching and describing the physical and chemical characteristics of active pharmaceutical ingredients to ensure that quality control meets standards.

Change Management Services

• Change Classification and Impact Assessment: Classify changes based on their type (minor, moderate, major) and assess their impact on product quality.
• Change Research and Validation: Conduct necessary process research and validation, providing inspection reports for three consecutive batches of samples and stability study data.

Registration Platform Operation

• Platform Registration: Register on the raw and auxiliary material registration platform established by NMPA to ensure that formal review is completed within five working days to obtain a product 'registration number'.
• Information Disclosure and Publicity: Ensure that registration information is open and transparent to promote the healthy development of the pharmaceutical industry.

Registration of Active Pharmaceutical Ingredients, Excipients, and Packaging Materials

• Active Pharmaceutical Ingredient Registration: Provide professional services for active pharmaceutical ingredient registration, including registration forms, basic information, production information, characteristic identification, etc.
• Excipient Registration: For various types of excipients, provide registration material preparation services that meet specific formulation applications and technical requirements.
• Packaging Material Registration: Provide professional registration services for pharmaceutical packaging materials, including new materials, new structures, and new uses.

Active Pharmaceutical Ingredient Registration

Registration Conditions

Before the implementation of related review and approval policies, raw and auxiliary materials that have previously obtained approval documents and have been continuously used in formulations will have their approval information transferred to the registration platform by NMPA and assigned a registration number. The registration status will be marked as 'a'.

For generic active pharmaceutical ingredients already on the market domestically, registration can be done separately without linking to drug formulations; it will undergo independent review. After passing the review, the registration status will be marked as 'a', while those not passing will be marked as 'i'.

Application Materials

• Active Pharmaceutical Ingredient Registration Form.
• Basic information including company information, product name, structure, etc.
• Production information such as production processes, production equipment, etc.
• Characteristic identification involving research and description of physical and chemical characteristics of active pharmaceutical ingredients.
• Quality control of active pharmaceutical ingredients including quality standards, inspection methods, etc.
• Reference substances providing relevant information and sources for reference substances.
• Packaging materials; if specific packaging materials are used, relevant information must be provided.
• Stability; provide stability study data for active pharmaceutical ingredients.

Excipient Registration

High-Risk Excipients:For animal-derived or human-derived excipients used in high-risk formulations such as injectables, ophthalmic preparations, inhalation preparations, etc., registration material requirements can be provided based on the excipient's application in specific formulations as well as corresponding technical requirements. Additional materials may also be supplemented during the review process based on specific formulations and excipient applications in those formulations.

Excessive Use of Excipients:For excipients with a history of use exceeding significant historical usage amounts for corresponding administration routes, relevant safety data must be provided.

Premixed Excipients: Choose appropriate material requirements for registration based on their application in formulations and the composition of each excipient in the formulation.

Packaging Material Registration

High-Risk Packaging Materials:'High-risk packaging materials' include those for inhalation preparations, injectables, ophthalmic preparations that are specifically required by NMPA based on monitoring data. New materials, new structures, or new uses also fall under this category. The state encourages registration according to packaging systems; if it cannot be registered according to a complete packaging system due to technical reasons, it can also be registered according to packaging components.

'Change Management'

'Active Pharmaceutical Ingredient Changes'

• 'Minor changes require a description of specific circumstances and reasons for changes. Research/validation studies must be conducted on the changed process. Provide inspection for one batch sample and reflect long-term stability assessment results in annual reports.'
• 'Moderate changes require process research and validation as well as sterile/sterilization process validation. Provide one batch production record along with quality comparison studies. Inspection for samples from one to three batches is required along with at least three months' worth of stability study data at application time. One batch must undergo accelerated/long-term stability studies.'
• 'Major changes require process research and validation as well as sterile/sterilization process validation. For changes affecting product structure, structural confirmation must be provided. Provide one batch production record along with quality comparison studies. Inspection for samples from three consecutive batches is required along with three to six months' worth of stability study data at application time. Three batches must undergo accelerated/long-term stability studies.'

'Excipient Changes'

• 'Minor changes require corresponding research on changes. Provide an inspection report for one batch. If there are changes in excipient suppliers that may affect dissolution behavior, a dissolution curve comparison study must be conducted. Long-term stability data for the first batch must also be provided in annual reports.'
• Moderate changes require corresponding research on the changes, providing batch production records, 1-3 batch inspection reports, and comparing the dissolution curves, impurity profiles, and key physicochemical properties of samples before and after the changes. They should remain consistent and comply with guidelines, providing 1 batch of accelerated and long-term stability data for 3 months compared to before the changes.
• Significant changes require corresponding research on the changes, providing batch production records, continuous 3 batch inspection reports, and comparing the dissolution curves, impurity profiles, and key physicochemical properties of samples before and after the changes in accordance with guidelines. Provide 3 batches of accelerated and long-term stability data for 3-6 months compared to before the changes. If applying for exemption from bioequivalence studies, sufficient justification must be provided.

Change of drug packaging materials

• Minor changes mainly involve quality comparison studies related to packaging characteristics before and after the change, providing 1 batch inspection report, and including the first batch long-term stability investigation study in the annual report.
• Moderate changes involve packaging process validation, aseptic/sterilization process validation, quality comparison studies involving comparative studies of packaging materials and container characteristics before and after the change, equivalence/replacement studies of packaging materials, compatibility and sealing studies of packaging materials. Provide 1-3 batch inspection reports and 1 batch of accelerated and long-term stability investigation studies.
• Significant changes involve packaging process validation, aseptic/sterilization process validation, quality comparison studies involving comparative studies of packaging materials and container characteristics before and after the change, equivalence/replacement studies of packaging materials, compatibility and sealing studies of packaging materials, as well as accuracy studies of dosage administration. Provide continuous 3 batch inspection reports and 3 batches of accelerated and long-term stability investigation studies for 3-6 months.