Pharmaceutical regulatory science sem8 (unit2) notes

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Regulatory approvals process is a procedure by which a regulatory agency reviews and assesses the safety, efficacy, and quality of a product or service in order to determine whether it meets the regulatory agency’s criteria for approval. The regulatory approvals process is implemented to ensure public health and safety and to protect consumers from false or misleading claims.

Here are the overview of steps in regulatory approvals process:

1. Preclinical Testing: In this phase, the product undergoes laboratory testing in animals or cells to determine its safety, pharmacokinetics, and toxicity.

2. Investigational New Drug (IND) Application: Once preclinical testing has been successfully completed, an IND application is submitted to the regulatory agency.

3. Clinical Trials: The product then undergoes clinical trials, which involves testing the product in humans to evaluate its safety and efficacy. These trials typically involve three phases of testing, each with a different focus of investigation.

4. New Drug Application (NDA) or Biologics License Application (BLA): After the clinical trials have been completed, the sponsor can submit an NDA or BLA to the regulatory agency.

5. Review and Approval: The regulatory agency reviews the application, paying special attention to the safety, efficacy, and quality of the product.

6. Post-Approval Monitoring: If the product is approved, the regulatory agency continues to monitor it to ensure ongoing safety and effectiveness.

In addition to the above approach, the regulatory approval process may also apply to medical devices, food, cosmetics, and other products. The process can vary from country to country and sometimes even from state to state. Companies who intend on creating new products or services should research the regulatory approval process for their specific industry and location to ensure they have a comprehensive understanding of the requirements.