Any prescription drug has to undergo major five qualification phases. The entire process for new drug approval/registration would take at least ten years.
SSI assists medical institutions obtain quality data while ensuring a safer environment.
1. Basic Research (2 - 3 years)
As an initial step, thousands of candidate compounds are collected or synthesized for testing. Candidates are diversely evaluated for various aspects of pharmaceutical benefits. Very few ingredients will be qualified to the second step, the "Non-clinical Trial".
2. Non-clinical Trial (3 - 5 years)
The remaining compounds screened out from the basic research are then tested for "Non-clinical Trial." Non-clinical tests use animals and cell cultures to gain scientific prediction of their safety and efficacy for human use.
3. Clinical Trial: Phase I to III (3 - 7 years)
Once candidate compounds are concluded effective, the non-clinical trial concludes the safety and efficacy of the candidates, they then move on to the next step, the "Clinical Trial" performed on actual human subjects. These clinical trials are the first stage of SMOs' involvement.
The entire procedure of the "Clinical Trial", before applying for the approval review, can be divided into three stages: Phase I to Phase III.
As the "Clinical Trial" involves humans in the procedure, it must abide by GCP's operational standards in order to guarantee the protection of participants' rights and safety, and to ensure its scientific quality and reliability of results.
1. Phase I
Candidate drugs for new pharmaceuticals during clinical trials are sometimes called "Investigational Drug". We ask healthy subjects to use an investigational drug to ensure that it is safe to be used by other people. Furthermore, detailed research and studies are conducted on how the human body absorbs, breaks down and eliminates a given investigational drug.
2. Phase II
If an investigational drug passes the Phase I trial, it then enters the Phase II trial. During this trial, a small number of patients will participate as subjects to verify the safety and the effectiveness of the investigational drug.
Moreover, detailed research and studies are conducted to determine the best possible method of prescribing the investigational drug in question.
This is the first stage that SSI participates in the support of clinical trials
3. Phase III
The next step, after meeting the requirements of the Phase II trial, is the Phase III. During this trial, a large number of patients participate in the process as subjects to verify once again the safety and the effectiveness of the investigational drug. Furthermore, this is the final stage that evaluates the product and determines its suitability to market.
SSI assists with various duties during this Phase III clinical trial
4. Review for Approval (2 - 3 years)
If the investigational drug is deemed suitable for the market, an application will be submitted to the Ministry of Health, Labor and Welfare to obtain an approval to manufacture. All data obtained up to the submission of the application are then forwarded to the Ministry where they are examined with strict scrutiny for quality. A detailed and strict review is conducted on the safety and effectiveness of the investigational drug in question. (The method of production of the investigational drug is also reviewed here.)
Only after obtaining the Ministry's approval can an investigational drug be put on the market as a "medicine".
5. Post Marketing Surveillance (PMS)
After receiving approval, the product is then released to the marketplace; however, the "medicine" remains a target for research for six years.
Research is conducted to verify the safety and effectiveness of the product for people of various ages and health conditions. Their results are submitted to the Ministry of Health, Labor and Welfare. There may be a Phase IV clinical trail to obtain data not collected during the preceding three phases.
Participation in clinical trials is solely based on the participants' free will. It is possible that a participant could choose to refuse to participate after signing an agreement or to cease to participate in the middle of the clinical trial. There is no penalty or liability in doing so.
Furthermore, all questions and doubts from any person regarding clinical trials must be addressed until he or she is thoroughly satisfied.
CRCs (Clinical Research Coordinators) from SSI visit medical institutions as clinical trial specialists. They comprehensively address any concerns regarding clinical trials expressed by medical staff and patients participating in the procedure, in order to keep both parties thoroughly satisfied with the process
| Who is SMO? |
| What is GCP? |
| How medeicine is manufactured |