Medicinal Gases Registration
Regulatory Editor
06/05/2022
This article describes the procedures and the requirements for submitting an SFDA registration application for medicinal gases products in Saudi Arabia. What are Medicinal gases?
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SFDA Labelling and Packaging Requirments
Regulatory Editor
23/04/2022
SFDA has strict labelling and packaging requirements that companies have to comply with during the submission of the registration application. Once this application is approved,
SFDA Requirments for Clinical Trials in Saudi Arabia
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23/04/2022
Clinical trials (CT) are research that studies new tests and treatments and evaluates their effects on human health outcomes. This article will explain the SFDA
SFDA Food Supplements Registration
Madiha Baaj
17/04/2022
The SFDA registration for food supplements in Saudi Arabia is in more than one procedure and it is always tricky for foreign manufacturers who get
NDLP: Saudi Pharmaceutical Market is expected at $11.7 billion by 2030 (Views on Medical Devices Included)
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The Saudi National Industrial Development and Logistics Program (NDLP) predicts that the size of the pharmaceutical market in the Kingdom will reach 44 billion Riyals
SFDA UDI Requirements for Medical Devices
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29/07/2021
What is the SFDA UDI requirements in Saudi Arabia and how to comply. Read all details including timelines and compliance obligations.
SFDA Fees: details of +50 types of applicable fees
Regulatory Editor
18/06/2021
In this post we detail the SFDA fees for registration of drugs and medical devices, and other types of products. It should help budgeting for regulatory costs.
Pharmacovigilance & QPPV Requirements in Saudi Arabia
Mohammed Jobran
03/05/2021
Details about the SFDA pharmacovigilance in Saudi Arabia and its requirements. When and how to hire a QPPV or contract with a pharmacovigilance Consultancy as per the SFDA pharmacovigilance guidelines GVP.
SFDA Variation Guidelines Overview
Regulatory Editor
21/04/2021
An overview on the SFDA variation guidelines (GCC) and the requirements for the variation submission. Covering timelines, fees, files, and application.
SFDA Verification & Abridged Procedure for EMA/FDA approved applications
Mohammed Jobran
12/03/2021
How EMA and FDA approvals help in getting SFDA approval in an accelerated assessment procedure. Learn more about what is called Abridged and verification registration.
SFDA Stability Study Requirements
Mohammed Jobran
12/03/2021
Stability studies are one of the important quality parameters of pharmaceutical products. It sets the drug shelf life, determines proper storage conditions, and therefore the
SFDA Classification
Regulatory Editor
12/03/2021
This is the most simple procedure at the SFDA where companies can apply to know their product’s SFDA classification. Note that it only clarifies the
SFDA GMP: Manufacturer Registration Process
Regulatory Editor
12/03/2021
To market pharmaceutical products in Saudi Arabia, SFDA requires manufacturers to adhere to Good Manufacturing Practice (GMP). It is basically the implementation of proactive quality
SFDA Priority Review: 40% Faster Registration
admin
12/03/2021
A description of SFDA criteria for the eligibility of priority review of drug applications. The conditions in details and the other accepted cases.
How to Develop a Regulatory Strategy for the Saudi Market
Mohammed Jobran
12/03/2021
An overview on the regulatory strategy development process for the Saudi market. The analysis methods, elements to consider, documentation, and the series of recommended stages.
SFDA Registration & Market Regulations
Mohammed Jobran
11/03/2021
Learn about SFDA registration in Saudi Arabia covering different types of product applications, files, requirements, fees, and timelines. Also the Saudi FDA regulations for market entry.
SFDA Medical Device Registration
Ghulam Bhat
11/03/2021
In details, the SFDA medical device registration, classification, and application requirements with fees and timelines for different risk classes according to Saudi Arabia medical device companies regulation.
SFDA Drug Registration Requirements
Mohammed Jobran
11/03/2021
Detailed description of the SFDA drug registration requirements in Saudi Arabia. The related guidelines and regulations for different types of new and generic drug applications in SFDA. Including file structure and how to submit it in eCTD.
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