The process for submitting toxicological data typically involves several steps:
Data Collection: Companies must gather comprehensive toxicological data through laboratory and animal studies. Compilation of a Dossier: The data is compiled into a detailed dossier, including study reports and safety assessments. Submission to Regulatory Agency: The dossier is submitted to the appropriate regulatory agency for review. Review and Evaluation: The agency conducts a thorough review of the data, often involving independent expert panels. Approval or Rejection: Based on the evaluation, the agency either grants approval for market entry or rejects the application, often with recommendations for additional studies or data.
