Purpose: establishing the JSPS

Since the publication of the ICH S7A guideline in 2000, safety pharmacology studies have played an important role in the safety evaluation of pharmaceuticals, and are now considered a necessary component of drug development and marketing authorization applications. Since the publication of the ICH S7A guidelines in 2000, safety pharmacology studies have played an important role in the safety evaluation of drugs, and are now undergoing a major transformation. In addition to the routine studies conducted before a drug is administered to humans for the first time, there are now an increasing number of safety pharmacology studies for anticancer drugs, biopharmaceuticals, and other drugs that require evaluation that is both conceptually and technically different from the conventional studies. In addition, there is a strong social demand to conduct animal studies in accordance with the spirit of the 3Rs, and the incorporation of safety pharmacology endpoints into toxicity studies is becoming a major issue, and research has begun on the technical infrastructure for this purpose. Furthermore, while new tools such as iPS cells are expected to be applied to safety pharmacology evaluation, safety in specific patient populations is attracting more attention in clinical trials, and the corresponding needs for safety pharmacology evaluation in non-clinical settings (e.g., using pathological animal models) are also expected to increase.

The international Safety Pharmacology Society was established in 2001 to support this research field. The 2009 meeting brought together more than 450 people from industry, government, and academia to exchange information on the state of evaluation and methods used in such studies. In Japan, however, although the personnel in charge of safety pharmacology studies at pharmaceutical companies have developed their own knowledge and experience, there has been no place for them to gather together and exchange their skills and knowledge.

Against this backdrop, we thought it would be timely and extremely meaningful to establish a study group where Japanese researchers interested in the techniques, evaluation methods, and clinical extrapolation involved in safety pharmacology studies could meet and exchange information on safety pharmacology studies. We also believe that such a study group in Japan, in collaboration with the International Safety Pharmacology Society, will lead safety pharmacology research in Asia from both scientific and regulatory science perspectives.

Therefore, the founders have decided to establish the Japanese Safety Pharmacology Society (JSPS). With the vision of "supporting the safety evaluation of drugs from the viewpoint of pharmacology," the society will sponsor a scientific meeting at least once a year to provide an opportunity for researchers involved in safety pharmacology studies to gather together.


December 2, 2009
All the founders