1, Note for Guidance on Good Clinical Practice (E6). Effective date: 17th January 1997.highlighting point 04. Investigator gcp1.pdf
2. Clinical trials in minors. Directive 2001/20/EC Article 4
http://ec.europa.eu/health/files/eudralex/vol-10/ethical_considerations_en.pdf
3. EU GCP Directive 2005/28/EC. 3.dir_2005_28_en.pdf
4. Helyes Klinikai Gyakorlat. (Good Clinical Practice) gcp_ogyi.pdf
5. Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric population.
ICH11--CHMP/ICH/2711/99 5.wc500002926.pdf
6. Ethical Consideration for Clinical Trials on Medicinal Products conducted with the paediatric population ethical_considerations_en.pdf
7. 235/2009. (X.20.) Korm. Rendelet 235.2009.docx
8. 35/2005 (Vlll.26.) EüM rendelet 35.2005.docx
9. Regulations on paediatric medicinal products.
Regulations (EC) No 1901/2006 9.reg_2006_1901_en.pdf
10. Regulations on advanced therapy medicinal products.
Regulations (EC) No 1394/2007 10.reg_1394_2007.pdf
11. WHO Global campaign"Make medicines child size".
www.who.int./childmedicines/en11.paediatric-clinical-trials-guidance.pdf