On the issue of applying for drug registration in the name of an individual

After your documents are ready, the company generally needs to sort out your documents, and there are special personnel to write the materials, everything is ready, and you can get the patent acceptance notice on the day of submission, and there is a patent number on it; Generally, drugs are applied for invention patents, and now it takes about 2 to 3 years to be authorized.

If you want to apply for a trademark, natural persons are not allowed, but industry and commerce generally do not approve individual processing drug licenses, unless you apply for a trademark in the name of a company, there is no restriction.

It depends on what your specific situation looks like.

The listing of drugs is not so simple, and the approval of the Drug Administration must first be obtained for production, and it will take more than 3 years to approve only one item, and more than 3 million yuan will be invested. The general flow is:

Pharmaceutical research, pharmacological research, application for clinical study, approval of clinical study, conduct of clinical study, application for production, approval of production.

Pharmaceutical research takes 3 to 6 months and costs 300,000 yuan; Pharmacological research takes 6 to 12 months and costs 50.8 million; The cost of both of these is out of your own pocket, and no one will invest in you. After that, the clinical research will take 1 3 years and cost 100 3 million, so that there may be companies interested in your product and will buy yours, of course, there may be no one who cares about it, so you have to pay for it yourself. So, if you don't have two or three million in your hand, don't bother with the idea.

Legal analysis: Drugs marketed in China shall be approved by the drug regulatory department and obtain a drug registration certificate; However, there is an exception for Chinese herbal medicines and Chinese herbal decoction pieces that have not been approved or managed by the Bureau. For drugs applying for registration, the drug regulatory department shall organize pharmaceutical, medical and other technical personnel to conduct a world review to review the safety, effectiveness and quality controllability of the drug, as well as the applicant's ability to manage quality, risk prevention and control and liability compensation; If the conditions are met, a drug registration certificate will be issued.

When approving drugs, the drug regulatory department shall review and approve the chemical raw materials, the relevant excipients, packaging materials and containers in direct contact with the drug, and the quality standards, production processes, labels and instructions of the drugs.

Legal basis: Drug Administration Law of the People's Republic of China

Article 24 Drugs marketed in China shall be approved by the drug regulatory department and obtain a drug registration certificate; However, Chinese herbal medicines and Chinese herbal decoction pieces that have not been subject to approval management are excluded. The catalogue of varieties of Chinese herbal medicines and Chinese herbal decoction pieces that are subject to approval and management shall be formulated by the drug regulatory department in conjunction with the competent department of traditional Chinese medicine. To apply for drug registration, true, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of the drug.

Article 25.

For drugs applying for registration, the drug regulatory department shall organize pharmacical, medical and other technical personnel to conduct a review to review the safety, effectiveness and quality controllability of the drug, as well as the applicant's ability to manage quality, risk prevention and control and liability compensation; If the conditions are met, a drug registration certificate will be issued. When approving drugs, the drug regulatory department shall review and approve the chemical raw materials, the relevant excipients, packaging materials and containers in direct contact with the drug, and the quality standards, production processes, labels and instructions of the drugs. The term "excipients" in this Law refers to the excipients and additives used in the production of drugs and the preparation of prescriptions.