The Institute for Standardization and Control of Pharmaceuticals is the Institute in the Ministry of Health that is responsible for ensuring the quality of medicines marketed in Israel. The Institute’s activities are regulated under the provisions of the Pharmacists’ Regulations (Preparations) 1986, and the Pharmacists’ Regulations (Good Manufacturing Practices) 2008. The Institute supervises biological and chemical drugs for human use and for veterinary use, both locally manufactured and imported.
The Institute’s activities include the following three fields:
- Supervision of pharmaceutical plants
- Laboratory testing of medicines
- Assessment of data regarding the quality of medicines submitted for licensing in Israel.
There is a Quality Assurance Unit in the Institute that operates in all units of the Institute, with the objective of ensuring that all the Institute’s processes and activities are carried out at the required standards of quality.
