Step 1: initially establish the research direction, determine the medical effect, main ingredients, dosage forms, market value of the product, etc.
The second part is to consult the literature, collect relevant information and pay attention to avoid infringing others' patents.
The third step is to open questions, collect and sort out the data, apply for funds, and prepare to research and develop e68a84e8a2ad7a6869616f313363396466.
The fourth step is to explore the prescription and technology, which starts a lot of experiments, including the quality research of raw and auxiliary materials, the selection of key parameters of preparation technology, the rationality of prescription ratio, etc.
The fifth step is to carry out small-scale trial production and process amplification (depending on the difficulty of production, whether it needs to be enlarged or not), and carry out quality research for products.
Step 6: phase I clinical trial (according to different types of application and registration, see the drug registration management measures for details, which can be omitted)
In the seventh step, after the optimization of the product process, the batch scale-up is carried out, three consecutive batches of large-scale production are carried out, and the process verification is carried out simultaneously.
The eighth step is to carry out quality research, stability test, establish quality standards and carry out methodology verification.
Step 9: collect validation data, pharmaceutical research data, literature, etc. Collect and sort out materials for drug registration.
Step 10: the superior competent department (Drug Administration) shall send personnel to carry out process inspection and sampling at the same time.
Step 11: after the verification, the drug regulatory bureau starts to review the varieties. After passing the review, the approval documents can be issued to approve the production. Complete drug development and registration.
However, three-stage clinical trials, follow-up studies on drug stability and adverse reactions are still needed.
If it is simpler, it is mainly divided into:
Literature review in the early stage of R & D, prescription process exploration, laboratory small test and pilot scale-up (phase I clinical test is required for class I new drugs at this time), process validation and quality research, application of data collection, on-site verification by the drug regulatory bureau, and production approval document issued after approval.