Regulatory Management and Product Registration

The regulatory unit has been established to review domestic and foreign laws and regulations for the registration of herbal, human, and veterinary medicinal products, cosmetics, and supplements. This unit plays a vital role in ensuring the quality and safety of products, and a product’s identification is developed within this unit.

Summary of Regulatory Unit Activities:

  • Documentation: Relevant files are documented based on DMF, PMF, PIF, and CTD formats for drugs in English. This documentation includes detailed information about compositions, manufacturing processes, and clinical and preclinical effects.
  • Data Analysis: Collected information is specified according to the laws and regulations of the relevant country. This stage includes the evaluation of documents and review of test results. Additionally, clinical data analysis is conducted to assess the effectiveness and safety of products.
  • Data Updates: Preclinical and clinical information and data are updated to ensure compliance with the latest standards. These updates help the regulatory unit stay aligned with the latest scientific and technological advancements.
  • Document Submission: At specified times, the necessary responses and documents are provided to experts, enabling faster product approvals. This stage involves collaboration with other relevant entities and experts to secure the required documentation.
  • Review and Final Approval: Monograph information, labels, and final documents are reviewed and approved to ensure the accuracy of information. This action helps reduce errors and shortcomings in the approval process.

 

Regulatory Unit

 

Importance of the Regulatory Unit:

This entity contributes to public health by controlling quality and safety, thereby increasing consumer trust. By thoroughly reviewing laws, the entry of non-standard products into the market is prevented. Furthermore, the regulatory unit facilitates the export of products by establishing international standards, thus aiding the development of the pharmaceutical industry.

Conclusion:

Ultimately, the regulatory unit serves as a key entity in the pharmaceutical and cosmetic industries, playing an important role in safeguarding public health. Given the rapid scientific and technological advancements, this unit must remain updated to respond to the new challenges of the industry. Close collaboration with researchers, manufacturers, and other entities can enhance the quality and safety of products.