The pre-clinical research stage mainly involves the following steps:
- Initiate the research project, study the project feasibility and develop a plan for testing and producing the new medicine;
- Develop the scope and the techniques for testing the new medicine in the laboratory;
- Develop laboratory-scale manufacturing process for the new medicine;
- Develop the manufacturing process for the new medicine on an expanded basis in the workshop;
- Develop the virus inactivation process/techniques, engage qualified institution to assess the virus inactivation process/techniques, and report the related documents to the related government authority for re-assessment.
The clinical trial application stage mainly involves the following steps:
- Submit required sample products and documents to the Provincial Food and Drug Administration (“PFDA”). PFDA will perform an on-site examination on the documents and equipment, and then transfer all the required materials to the China Food and Drug Administration (“CFDA”), who will further review the documents and test the sample products;
- Submit a draft clinical trial program to CFDA for the application of the clinical trial;
- Approval of the clinical trial.
Clinical trials range from Phase I to IV:
- Phase I: preliminary trial of clinical pharmacology and human safety evaluation studies. The primary objective is to observe the pharmacokinetics and the tolerance level of the human body to the new medicine as a basis for ascertaining the appropriate delivery methods or dosage.
- Phase II: preliminary exploration on the therapeutic efficacy. The purpose is to assess preliminarily the efficacy and safety of the new medicine on patients and to provide the basis for designing dosage tests in phase III.
- Phase III: confirm the therapeutic efficacy. The objective is to further verify the efficacy and safety of the new medicine on patients, to evaluate the benefits and risks and finally to provide sufficient experimental evidence to support the registration application of the new medicine.
- Phase VI: application research conducted after the launch of a new medicine. The objective is to observe the efficacy and adverse reaction of the new medicine under extensive use, to perform an evaluation of the benefits and risks of the application among ordinary or special group of patients, and to ascertain and optimize the appropriate dosage and formula for application.
The registration stage mainly involves the following steps:
- Submit documents related to pre-clinical and clinical trials to PFDA, which will perform on-site inspection on the clinical trials and then transfer the related documents to CFDA for further review;
- On-site inspection by CFDA on three consecutive sample productions at the production facilities;
- Grant of the manufacturing approval certificate following the public notification period;
- Grant of GMP certificate following the public notification period.