**The Egyptian Drug Authority announces the publication of the following draft regulatory guideline:**

**ICH M4Q(R2) Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality**

We are honored to receive your feedback through the "Public Consultation Form" via the following email: **biots.da@edaegypt.gov.eg**

This initiative aims to provide all stakeholders with the opportunity to participate by sharing their opinions and comments.

**Consultation period: From 06/07/2025 to 26/10/2025**

This comes in light of the Egyptian Drug Authority’s membership in the International Council for Harmonisation (ICH), its active role within the council, and its contribution to the development of the guidelines issued. It also reflects the Authority’s commitment to keeping pace with modern scientific advancements to ensure the availability of innovative pharmaceutical products with advanced technologies, while guaranteeing their quality, efficacy, safety, and regulatory alignment.

- **To view the draft guideline, please click the link**
- **To access the training materials, please click the link**