Drugs

Extending Validity Period for Pharmaceutical Products

2020-04-06
Extending Validity Period for Pharmaceutical Products
Guide
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Warning Date
    2021-03-25

“SFDA” Suspends and Withdraws the Registration of (LORA S Tablet‎) and (LORINASE Tablet‎)

2021-03-25

The Saudi Food & Drug Authority (SFDA) has announced the withdrawal and suspension of registration of the pharmaceutical product (LORA S Tablet, batch number (8-968-15)) and (LORINASE TABLETS, batch number (250-212-09) ‎).

SFDA added that (LORA S Tablet‎) is marketed by Dammam Pharma Company, whether the other product (LORINASE Tablet‎)

  • To report sector-related issues

  • Call Centre 19999

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Warning Date
    2021-03-15

“SFDA” Withdraws and Suspends the Registration of Pharmaceutical Product “Proton”

2021-03-15

The Saudi Food & Drug Authority (SFDA) has announced the withdrawal and suspension of registration of the pharmaceutical product “PROTON 40mg E.C TABLET, batch number (134-212-01 &134-212-01) and “PROTON 20mg E.C TABLET, batch number (134-212-01 &135-212-01),

The Proton brand was manufactured by the Saudi Pharmaceutical Industries and Medical Appliances Corporation (SPIMACO)

  • To report sector-related issues

  • Call Centre 19999

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SFDA, OIC Conclude Joint Workshops

2021-03-24

Saudi Food and Drug Authority (SFDA) and the Secretariat General of the Organization of Islamic Cooperation (OIC) concluded today workshops that targeted OIC member states in the fields of organizing medical devices and products , and pharmacovigilance.
The third and final workshop, which was held on March 22-23, addressed the pharmacovigilance subject, during which discussions went over medicinal risks, monitoring the safety of proactive medicines and medicinal errors.

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Application for Variation to a Marketing Authorization

2021-03-25
Application for Variation to a Marketing Authorization
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Optional issuance of certificate for good manufacturing practice for cosmetics factories and Good distribution and storage practice for pharmaceutical warehouses

Optional issuance of certificate for good manufacturing practice for cosmetics factories and Good distribution and storage practice for pharmaceutical warehouses
Publication Date
Applying Date
2021-03-22

SFDA’s Drug Track and Trace System Monitors, Records over One Billion Supply Chain Operations

2021-03-15

 

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Policy guidance for Lot Release of Biological Products

2010-09-01
Policy guidance for Lot Release of Biological Products
Guide
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Data Requirements for the Renewal of Marketing Authorizations (Herbal and Health Products)

2012-05-01
Data Requirements for the Renewal of Marketing Authorizations (Herbal and Health Products)
Requirement
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