The SFDA, represented by its drug sector, has developed a draft for the (Regulatory Framework for Drug Approvals) in accordance with the SFDA decree no 1 dated 7-1-1424H, which states that the SFDA regulates and controls drugs marketed in Saudi Arabia.
The draft explains the workflow of registration files and documents for several kinds of authorization applications such as: marketing authorization application for new chemical entities, generics and biological products. Dealing with such files and documents will be electronic and application forms will be annexed to the draft.
The drug sector is pleased to receive opinions and comments of concerned people prior to 15-10-1429H, 15-10- 2008. A meeting will be held afterwards to discuss and introduce the final copy of the draft.
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To send opinions and comments please use the following:
Saudi Food and Drug Authority
Drug Sector
3292 Northern Ring Road - Al Nafal Distric
Riyadh 13312 – 6288
Kingdom of Saudi Arabia
Tel: +966-1-2759222 Ext: 1302
Fax: +966-1-2757195
E-Mail: hmhashan@sfda.gov.sa