Drug Discovery and Drug Development
Safe and effective new drugs created and nurtured over many years
A new drug (brand name drug) is delivered to patients only after a long process of basic research, various tests, and approval review by the government. After the drug is put on the market, it is used by many patients, and its safety and efficacy are repeatedly checked to ensure that it is safe and highly effective.
Drug Discovery
To create a drug, various tests are conducted to evaluate its efficacy and safety.
Drug Development
The use of a drug by a large number of patients provides a variety of information that can be used to nurture the drug.
Steps in New Drug Development
1. basic research 2 to 3 years
Discovery and manufacture of new substances that will become the basis of drugs
Drug development begins with research to discover or chemically create new substances (ingredients) that have the potential to become drugs in the future. The motto of a drug is extracted from natural materials (plants, animals, microorganisms, etc.), synthesized, or created using a variety of scientific and technological methods, including biotechnology. Recently, genomic information is also being utilized.
In addition, the properties and chemical structure of new substances are investigated and screened (sifted) to select the best ones.
Non-clinical trials 3-5 years
Research on Efficacy and Safety of New Substances
We study the efficacy and safety of substances that have potential as drugs by testing them in animals and cultured cells.
We also study the kinetics (absorption, distribution, metabolism, and excretion processes), quality, and stability of the substance.
Clinical trials (clinical trials) 3-7 years
Efficacy and safety testing on human subjects
The final confirmation that a drug candidate (investigational drug) that has passed the necessary non-clinical studies is safe and actually effective in humans is a clinical trial (Trial). Clinical trials are conducted in accordance with strict criteria known as GCP (*) and are based on reviews and examinations by many experts.
Clinical trials are divided into three phases and are conducted at hospitals and other medical institutions with the consent of healthy people and patients.
Prior to a clinical trial, the medical institution is required to provide detailed explanations in writing to patients who are to cooperate in the trial, to ensure that they fully understand the content, and to obtain their written consent. This is called informed consent.
Clinical trials are conducted in accordance with strict standards known as GCP (*).
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As of December 2023GCP : Good Clinical Practice
| Phase I | Confirmation of safety, including side effects, in a small number of healthy subjects. |
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| Phase II | Confirmation of effective and safe dosage and administration methods in a small number of patients. |
| Phase III | The efficacy and safety of the drug will be compared with those of existing drugs in a large number of patients. |
4. Application for approval and review Approx. 1 year
Application for approval to the Ministry of Health, Labour and Welfare (MHLW) and review by experts
After efficacy, safety, quality, etc. are confirmed in various trials, an application for approval is filed with the Ministry of Health, Labour and Welfare. The application is then reviewed by the Pharmaceutical Affairs and Food Sanitation Council, which consists of the Pharmaceuticals and Medical Devices Agency (PMDA) and academic experts.
5. Approval and launch
Approval by MHLW and listing on the NHI drug price standard
Once the drug is approved as a "drug," it can be manufactured and sold. The items and prices (NHI prices) of prescription drugs covered by medical insurance are determined by the Ministry of Health, Labour and Welfare based on the NHI drug price standard system. This is called the "NHI Drug Price Standard Listing.
6. Post-marketing surveillance and trials Phase IV (Phase IV)
Post-launch safety and usage checks
As drugs are used by many patients at various medical institutions, information may be obtained that leads to side effects and proper usage that could not be discovered during the development stage. For this reason, various checks are obligatory even after a drug is launched. Pharmaceutical information representatives (MRs*) of pharmaceutical companies collect this information.
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As of December 2023MR : Medical Representative
Improvement and development of drugs
Based on the information obtained from post-marketing surveillance, safer usage of the drug is examined and improvements are made to make the drug easier to use. This may improve the efficiency of treatment, increase the number of indications (target diseases), or provide hints for the development of the next new drug.
Column.
Clinical Trials" supported by the cooperation of patients
Patients play an important role in drug discovery and development. However, medical institutions and pharmaceutical companies alone cannot bring new drugs to the market. Clinical trials, which are conducted for the final check of the safety and efficacy of new drugs, require the cooperation of patients and healthy people.
The cooperation of patients, medical institutions, and pharmaceutical companies in "clinical trials" is the key to the creation of new drugs.