Скачать или смотреть Introduction to Pharmaceutical Regulatory Affairs

**Introduction to Pharmaceutical Regulatory Affairs

*Pharmaceutical Regulatory Affairs (RA)* is a specialized field that focuses on ensuring that *pharmaceutical products* — including drugs, biologics, and medical devices — comply with all *legal, scientific, and quality standards* required by national and international regulatory authorities.

It plays a crucial role in the *development, approval, manufacturing, and marketing* of medicines, ensuring that products are *safe, effective, and of high quality* before reaching patients.

🔹 Key Functions:

1. *Regulatory Strategy and Guidance:*
RA professionals plan and guide the drug development process according to regulatory requirements.

2. *Preparation of Regulatory Submissions:*
They compile and submit documents such as **IND (Investigational New Drug)**, **NDA (New Drug Application)**, **ANDA (Abbreviated NDA)**, and **MAA (Marketing Authorization Application)**.

3. *Compliance and Quality Assurance:*
Ensuring adherence to **Good Manufacturing Practices (GMP)**, **Good Clinical Practices (GCP)**, and **Good Laboratory Practices (GLP)**.

4. *Communication with Authorities:*
Acting as a link between the *pharmaceutical company* and *regulatory agencies* (e.g., USFDA, EMA, CDSCO).

5. *Post-Marketing Surveillance:*
Monitoring product performance, reporting adverse events, and managing lifecycle changes after approval.