Registration & Regulation

A drug’s research and development process culminates in its registration with the competent health authority (e.g., the Israel Ministry of Health and the U.S. FDA). In order to register a drug and receive a marketing license, the company has to submit a dossier to the health authority.

The dossier contains data on the chemical composition of the drug, the manufacturing processes, the quality indices, and the various tests and experiments (in the laboratory, in animals, and in humans) performed with the drug, demonstrating its safety and efficacy. The data is rigorously scrutinized by the health authority, and the manufacturing facilities and laboratories undergo a meticulous audit. At the end of the process the authority approves the drug and grants a marketing license.

Kamada has a dedicated regulatory affairs department staffed by highly skilled and experienced personnel. The team includes managers with extensive proven experience in the development and registration of drugs in many countries, where the company operates.