Work Procedures of New Drugs Development Department
I. New product information collection
The development department collects relevant product information based on the overall strategy of the company. Information collection is always a daily task of the development Department.A wealth of relevant information informs product development decisions.Therefore, the development to the Chinese medicine newspaper, "Chinese medicine economic news," the health "as the window of information collection, around the series products of the company set the development of children's strategy of actively collect information about children's cold medicine, in children collect related market information at the same time, further improve the Ed Koch, second-hand material, And keep an eye on what competitors are doing.
Ii. New product screening and proposal
With the support of sufficient information, the development Department shall conduct product screening by following steps:
1. Is the product market in line with the company's current strategic vision?
2. Is the technology of this product perfect at present?Can our existing human resources meet the technical requirements of this product?
3. Is the market for this product mature?Is our company competent enough to intervene in this market?
4. Can our company's financial resources meet the cost of product development and early-stage market development?
To this end, the development department should actively communicate with the company's expert consultants and propose to organize relevant departments of the company to conduct demonstration when necessary.
After passing the first four steps, the development department will draft the new product proposal and submit it to the general manager.
Three,
After the proposal is approved by the general manager, the project will be set up.
At this stage, the responsibility of the Development Department is to coordinate the relationship between the cooperative development units of new products, and the specific affairs are as follows:
1. Contract.
2. Advance payment.
3. Supervised the provision of relevant samples and other matters related to new drug application.
4. Preclinical studies
The new drugs that have been qualified after the basic improvement of the prescription in the pilot test are entered into the preclinical study.At this stage, the specific business of the development department is to do all related projects except human trials with the cooperative units.Such as: physics and chemistry, pharmacology, toxicology and so on.
Clinical research
New products qualified for preclinical study enter clinical study period.The main task at this stage is to carry out comprehensive research on the bioavailability, blood drug concentration, metabolic pathway and clinical treatment effect of the new product in accordance with relevant national regulations and designated clinical research hospitals.
6. New drug application
New drugs qualified for clinical studies shall enter the new drug application period according to the new drug grade of the new product and the requirements of the SDA for new drug approval.At this stage, the focus of the development department is to improve the data of new drug application and approval, and urge relevant departments to handle relevant procedures as soon as possible, until the new drug certificate is obtained.
7. Approve the application for document number
After the new product gets the certificate of new drug, the focus of the development department at this stage is to apply for approval number.The specific business is as follows:
1. Apply for relevant forms.
2. Instruct the process laboratory and production department to further improve the process and lay a good foundation for the next pilot test.
3, urge relevant departments to handle the approval number.
8. ADR monitoring
After the official production of the new product with the approval number, the focus of the development department will enter the ADR monitoring period.At this stage, the development department should cooperate with the customer service department of the company to make timely statistics and report the adverse reactions in the use of new products.Communicate with national ADR management department regularly, set up ADR files for new products, and establish a foundation for new product improvement.
Ix. Process improvement and prescription improvement
According to the ADR monitoring results of new products and the latest developments of medical research, the development Department has the right to propose improved process and improved prescription for new products already on the market.
Amity Pharmaceutical Co. LTD
May 18, 2001
