1, new drug application, new drug application refers to the application for registration of drugs that are not listed and sold in China;
2) Application for generic drugs refers to the application for registration of drugs with national standards that have been approved by the US Food and Drug Administration;
3. Application for imported drugs. Imported drugs refer to the application for registration of drugs produced outside China;
4, supplementary application, supplementary application refers to the new drug, generic drug or imported drug registration application is approved, change, increase or cancel the original approval items or content;
5. Re-registration application refers to the application for registration that the applicant intends to continue to produce or import the drug after the expiration of the validity period of the drug approval certificate.
What are the conditions for applying for a drug patent?
The conditions for applying for a drug patent are as follows:
1. An applicant for a patent for invention and utility model shall be novel, creative and practical;
2. The design for which a patent is applied shall be novel and not belong to the existing design; Moreover, it must not conflict with the prior patent rights of others, or violate the law, social morality or public interests.
Legal basis: Article 34 of the Measures for the Administration of Drug Registration
After the applicant has completed the pharmaceutical, pharmacological, toxicological and clinical trial research to support the drug listing registration, determined the quality standards, completed the verification of the commercial scale production process, and made good preparations for the drug registration verification and inspection, the applicant applies for the drug listing license, and submits relevant research materials according to the requirements of the application materials. Review the application materials in form, and accept them if they meet the requirements.