Journal of Developing Drugs
Open Access

Obtaining regulatory approvals for pharmaceuticl products in MENA region

5^th International Summit on GMP, GCP & Quality Control

August 12-13, 2016 Toronto, Canada

Dima Oscar

Hikma Pharmaceuticals, Jordan

Posters & Accepted Abstracts: J Develop Drugs

Abstract :

Obtaining Regulatory approvals for pharmaceutical products in MENA region is an essential requirement to market and sell pharmaceutical products in the fast growing market of the Middle East and North Africa region. My presentation will address the Regulatory Climate in MENA region, Regulations, Regulatory Pathways, Basic Registration Requirements, overview of Registration Files details, a brief comparison between the MENA requirements and the USFDA requirements to obtain regulatory approval to market pharmaceutical products.

Biography :

Email: DOscar@Hikma.com