(1), stability test data and conclusions of the drug, and relevant research data and literature on the service life of the drug.
(2), clinical research summary data compiled by clinical research units, with clinical reports of clinical research units.
(3), the quality standards and drafting instructions of raw materials (medicinal materials) and finished products for the production of drugs, and provide reference materials and information (reserved for the preliminary examination unit to review).
(4) At least 3 batches of samples (pilot products) produced continuously and their quality inspection and hygiene standard inspection reports (the number of samples in each batch should be at least 3 times of the requirements of full inspection).
⑤ Design samples and descriptions of performance, specifications and labels of pharmaceutical packaging materials. Instructions for use (trial use) of sample products, including drug name, specifications, main components (ingredients), theoretical or basic experimental description of traditional Chinese medicine, functional indications, usage and dosage, adverse reactions, taboos, precautions, storage, use period, manufacturer and product batch number. The identification of special drugs and drugs for external use must be indicated on the packaging and instructions for use. All the above information shall be provided for new drugs (preparations) in categories I to V.
2. Retrieval and analysis of Chinese medicine formula patents Before applying for a patent, it is best to search to determine which inventions belong to the "existing technology". If the content of the application has been recorded in the retrieved patent documents or other public publications, it may affect the authorization prospect of the application. In addition, even if there is no literature, the patent application will be rejected if others can determine that it is common knowledge in this field.
3. Writing scheme of Chinese medicine prescription patent: After searching the published materials, it is considered that the technology or drug has the three characteristics of "novelty, creativity and practicality" required by the patent, and the patent application document can be written.
4. Submit the application documents for the invention patent to the State Patent Office, and get the acceptance notice, confirming the application date and application number.
5, about 4-6 months from the date of application, through the preliminary examination and publicity.
6. When entering the substantive examination, the Patent Office will issue a notice of examination opinions and need to write a defense.
7 substantive examination found no reason for rejection, issued a notice of authorization, told to pay the registration fee and annual fee.