HISTORIA
Текст на Статията
- Good morning. I'm from the World Health Organization, and I'm here to evaluate your National Regulatory Agency. May I speak with the responsible representative?
- Good morning. I'm the representative from the NRA. Welcome to our agency. How can I assist you?
- Thank you. I'm here to assess your regulatory framework, organizational structure, and procedures related to medicine safety and efficacy.Could you provide me with an overview of your agency's processes?
- Certainly. Our regulatory framework follows international guidelines, and we have established processes for licensing, inspections, and post-marketing surveillance. Shall we proceed with a detailed discussion?
- I'd like to discuss your licensing procedures. Can you explain how you ensure that medicines meet the necessary standards before they are approved for use?
- Of course. Our agency follows a thorough evaluation process. We review the data provided by manufacturers, including clinical trial results and quality control information. We also consider international guidelines and collaborate with other regulatory agencies for assessments.
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