Registration procedure: Representatives designated by all shareholders or agents entrusted by * * * apply to the company registration authority for name pre-approval, go to the Food and Drug Administration with the Notice of Name Pre-approval and Pharmacist Qualification Certificate, open an account in a bank with the Notice of Name Pre-approval, and then go to an accounting firm for capital verification. After issuing the capital verification report, the accounting firm shall bring the certificates of all shareholders' designated representatives or entrusted agents, the notice of pre-approval of enterprise name, the capital verification report, the resolution of shareholders' meeting (the resolution to elect the magic weapon representative), the shareholder ID card, the company's articles of association, the license, the certificate of business premises and the house lease agreement to the Industrial and Commercial Bureau for registration. Then go to the tax bureau for tax registration certificate, and go to the Quality Supervision Bureau for organization code certificate.
Drug registration means that the State Food and Drug Administration of the United States systematically evaluates the safety, effectiveness and quality controllability of drugs to be listed according to the application and legal procedures of drug registration applicants, and decides whether to approve the application.
Application for registration:
Applications for drug registration include applications for new drugs, drugs with national standards, imported drugs and supplementary applications.
New drug application refers to the application for registration of drugs that are not listed in China. If the listed drugs change their dosage forms, routes of administration and add new indications, they shall be managed according to the application for new drugs.
Drug application with national standards refers to the application for drug production registration with formal standards issued by the US Food and Drug Administration.
The application for imported drugs refers to the application for registration of drugs produced overseas for sale in China.
Supplementary application refers to the registration application for changing, adding or canceling the original approved items or contents after the application for new drugs, drugs with national standards or imported drugs is approved.
For the registration of imported drugs, if an overseas production enterprise has no legal office in China, it must entrust a professional agency in China to register.
Re-registration application refers to the registration application that the applicant intends to continue to produce or import such drugs after the expiration of the drug approval certificate. [ 1]?
New drug registration:
New drug definition
According to the provisions of the Measures for the Administration of Drug Registration, a new drug refers to a drug that has not been listed and sold at home or abroad. If the dosage form and route of administration of listed drugs change, it shall be managed according to new drugs.
applicant
The applicant for drug registration (hereinafter referred to as the applicant) refers to the institution that applies for drug registration, bears corresponding legal responsibilities, and holds the drug approval certificate after the application is approved. The domestic applicant shall be a legal person institution legally registered in China, and the overseas applicant shall be a legal pharmaceutical production enterprise abroad. The personnel who apply for drug registration shall be the corresponding professional and technical personnel, who are familiar with the laws, regulations and technical requirements of drug registration management.
Citizens cannot register new drugs in their own names.
Application details
The State Administration of Pharmaceutical Products is in charge of the administration of national drug registration, and is responsible for the examination and approval of drug clinical research, drug production and import. The State Administration of Pharmaceutical Products entrusts the drug administrations of provinces, autonomous regions and municipalities directly under the Central Government to examine the completeness, standardization and authenticity of the application materials for drug registration.
To apply for drug registration, the applicant shall submit the application to the local drug administration of the province, autonomous region or municipality directly under the Central Government, and submit relevant materials and drug samples; The materials submitted for applying for new drug registration shall be complete and standardized, and the data must be true and reliable; References should indicate the name of the work, the name of the publication, the volume, the issue, the page, etc. Documents and materials that have not been made public shall provide the certification documents approved by the owner of the materials. Foreign language materials should be translated into Chinese as required. The State Administration of Pharmaceutical Products can quickly examine and approve the following new drug applications: (1) preparations made from medicinal substances such as plants, animals and minerals that are not listed in China, as well as effective components and preparations extracted from traditional Chinese medicines and natural medicines; (2) Chemical APIs, their preparations and biological products that have not been approved for marketing at home and abroad; (3) anti-HIV and new drugs for diagnosing and preventing AIDS, and new drugs for treating malignant tumors and rare diseases; (four) new drugs for diseases without effective treatment.
When applying for drug registration, the applicant shall promise that all test data are obtained by himself and ensure their authenticity.
When the applicant entrusts other institutions to carry out drug research or single test, detection, trial production and sample production, it shall sign a contract with the entrusted party. The applicant shall be responsible for the authenticity of the drug research data in the application materials.
Pre-clinical research on drugs registered, including synthesis process, extraction method, physical and chemical properties and purity, dosage form selection, prescription screening, preparation process, inspection method, quality index, stability, pharmacology, toxicology, animal pharmacokinetics, etc. The traditional Chinese medicine preparation also includes the source, processing and processing of the original medicinal materials; Biological products also include quality standards, preservation conditions, genetic stability and immunological research on raw materials such as bacterial strains, cell lines and biological tissues.
The applicant shall provide a description of the patent in China and the ownership status of the drug or the prescription and technology used in the application for registration, submit a guarantee that the patent of others does not constitute infringement, and promise to be responsible for the possible infringement consequences. Where a patent dispute occurs after the approval of the drug registration application, the parties concerned shall settle it through consultation, or through judicial organs or patent administration organs in accordance with the provisions of relevant laws and regulations.