Saudi Arabia – Regulatory Affairs
Saudi Arabia’s healthcare sector is experiencing its most crucial transition in the upcoming years as the government steps up to take on the role of regulator and not provider. The market, which was previously largely dominated by government companies is now transitioning as more private providers enter the market.
Regulatory Body - SFDA
The regulatory bodies in Saudi Arabia responsible for the registrations of drug products and medical devices is called the Saudi Food and Drug Authority.
Pharma Prescription Drugs
For Pharma products, there are two pathways to registration with the SFDA. The product is either considered a new drug or a generic product. Generic products are products wherein all APIs (with the same strength, dosage form, and therapeutic indication) are already registered in Saudi Arabia and new drugs are any product with an API not already registered in the Kingdom. All new drugs must submit a new drug application to the SFDA.
Consumer Healthcare Drugs/OTC
In Saudi Arabia, all OTC drugs must submit a registration dossier to the SFDA. However, since many OTC products can be considered “generic” under the SFDA’s requirements, there are exceptions that could help fast track the registration process that could shorten the time to market. With our long-term experience and network with the SFDA, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in Saudi Arabia.
In Saudi Arabia, all medical devices are regulated by the SFDA and must receive a Medical Device Marketing Authorization (MDMA) approval prior to placing the product on the market. Additionally, all medical devices must already be authorized in a reference country (Australia, Canada, Europe, Japan or the USA) to be considered for market approval. Medical devices are divided into four type – Classes I, II, III, and IV based on their level of risk. The rules for device classifications are quite specific and can vary greatly depending on different criteria.
Depending on their composition, food supplements in Saudi Arabia can be considered as either drug products or herbal products. Both drug products and herbal products must be registered with the SFDA prior to distribution but the pathways differ depending on the classification of the product, and there are also different labelling requirements.
Cosmetics and Derma
Cosmetics are defined as any substance or preparation intended to be placed in contact with the various external parts of human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition). In Saudi Arabia, all cosmetic products must be notified through the SFDA, and furthermore a local affiliate is mandatory for foreign manufacturers.
Frequently Asked Questions from clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- Will my existing BE studies be accepted in Saudi Arabia?
- What are the important things to take understand with regards to
trademarks by the SFDA?
- Can my home company act as a MAH in Saudi Arabia?
- What is the difference in climate zone for stability studies in Saudi Arabia vs. Europe and Latin America?
- Is the fast track registration process possible for my products in Saudi Arabia and what to be aware of?
- What are the pharma/prescription drug registration costs and time in Saudi Arabia?
- How many trademarks should be suggested to the SFDA and why?
- How can my own company be MAH in Saudi Arabia for my products?
- What are the Consumer Healthcare Drugs/OTC registration costs and time in Saudi Arabia?
- How to register Herbal and Phyto OTC drugs through SFDA via fast track process and why to prepare the market entry strategy before?
- What do I need to know about climate zone for stability studies in Saudi Arabia?
- Is a fast track registration process available in Saudi Arabia and what to make sure of?
- What is the difference between Medical Device registration and definition in Saudi Arabia vs. Europe, North America and throughout Latin America?
- Is my product considered a Medical Device by the laws of the SFDA?
- What are the important differences in trademark registration in Saudi Arabia with regards to the SFDA for Medical Devices?
- Are local clinical trials necessary in Saudi Arabia?
- Can my company act as a MAH in Saudi Arabia?
- Climate zone for stability studies in Saudi Arabia
- Is a fast track registration process available in Saudi Arabia and what to be aware of?
- How difficult is the registration of Medical Devices in Saudi Arabia?
- What are the Medical Devices registration costs and time in Saudi Arabia?
- To which class of Medical Devices does my product belong?
- How to register claims on the pack for Food Supplements in Saudi Arabia with the SFDA?
- Why trademark registration in Saudi Arabia can be a very difficult task with the SFDA?
- Can my company act as a MAH in Saudi Arabia for Food Supplements?
- What Climate zone for stability studies do I need for Food Supplements in Saudi Arabia?
- How difficult is the registration of Food Supplements/Nutraceuticals in Saudi Arabia?
- What are the Food Supplements/Nutraceuticals registration costs and time in Saudi Arabia?
- How to register claims in Saudi Arabia for Cosmetics with the SFDA?
- Why is the trademark registration for Cosmetics and Derma products a big topic in Saudi Arabia?
- Can my company act as a MAH in Saudi Arabia or do I need a local partner for registration?
- What are the important topics about climate zone for stability studies in Saudi Arabia?
- How difficult is the registration of Cosmetics in Saudi Arabia?
- What are the Cosmetics registration costs and time in Saudi Arabia?