Saudi Arabia: SFDA issues new guidelines
for the registration of pharmaceutical products
Healthcare & Life Sciences Focus
SFDA issues new guidelines for the registration of pharmaceutical products
Partner, Head of Innovation,
Patents & Industrial Property (3IP)
The regulatory framework for innovators and pharmaceutical products is constantly evolving in Saudi Arabia. In recent years, there have been several significant changes to this framework, including the implementation of new regulations and guidelines, as well as updates to existing ones. These changes are designed to help promote innovation in the pharmaceutical industry while also ensuring that patients have access to high-quality, effective treatments. Some examples of regulatory framework changes that have been made in recent years include updates to the clinical trial process, changes to the approval pathway for new drugs, and revisions to post-marketing requirements. It is important for companies in the pharmaceutical industry to stay up to date with these changes to ensure compliance and to be able to bring their products to market in a timely and efficient manner.
This article addresses some of the common questions we receive from clients in relation to the new regulatory framework and updated procedures and requirements to be followed by pharmaceutical companies at the time of seeking marketing approval for their products from the SFDA.
Saudi Arabia’s New Procedure for Registration of Innovator and Generic Pharmaceutical Products
The Saudi Food and Drug Authority (“SFDA”) in collaboration with the Saudi Authority for Intellectual Property ("SAIP”) recently on 28 November 2022 (“Publication date”), enacted a new procedure (“Procedure”) to accelerate the regulatory process. The Procedure outlines the requirements to be adhered to by both a generic and an innovator company while registering a pharmaceutical product(s) with the SFDA. The main objective of the Procedure aims to raise the level of transparency in the procedures of the SFDA, enhance confidence in the guidelines for patent registration of pharmaceutical products, and facilitate the procedures for registering generic pharmaceuticals.
Procedure for Innovator Companies
In accordance with the new Procedure, all innovator companies whilst applying for marketing approval for their pharmaceutical product(s), must submit in the product registration file- a copy of the Registration Certificate issued by SAIP and/or the GCC Patent Office protecting the pharmaceutical product for which the marketing approval is being sought. In case a valid GCC or KSA patent (“Local Patent”) has not yet been granted at the time the innovator company submits the product registration application to the SFDA, the Registration Certificate must be submitted within thirty (30) days of its issuance. If marketing approval is being sought for a pharmaceutical product that is not protected by a Local Patent, then in such a scenario the innovator company must submit a statement, particularly referred to as a “Patent Statement” undertaking and confirming that there are no Local Patents protecting the said pharmaceutical product in Saudi Arabia and/or the GCC.
It is worth noting that the Registration Certificate must be issued either by SAIP or the GCC Patent Office. Registration Certificates issued by Patent Offices from other jurisdictions will not be considered. Saudi Arabia requires a pharmaceutical entity to have Local Patent protection for their pharmaceutical products to prevent a generic from entering the pharmaceutical market and seeking marketing authorization from SFDA. If a pharmaceutical entity has a valid patent in any other part of the world, it cannot claim equivalent protection based on that patent (a patent of origin) in Saudi Arabia.
Procedure for Generic Companies
The procedure to be followed by generic companies varies depending on the existence or absence of a valid Local Patent protecting an innovative pharmaceutical product.
When there is a Local Patent protecting the innovator’s product in Saudi Arabia
When the SFDA has in its records a Local Patent associated with the Innovative Product, generic companies when applying for registration of the generic pharmaceutical product must submit in the product registration file- a Freedom to Operate (“FTO”) report issued by one of the intellectual property agencies listed at SAIP. The FTO report must be submitted within sixty (60) working days from the date of the request. The FTO report must include an acknowledgment and undertaking that the generic product does not infringe on any existing valid Local Patents protecting the innovator pharmaceutical product. In case the generic company submits such an FTO with an undertaking of non-infringement, the SFDA will accept the product registration request and grant the marketing approval. In contrast, in absence of such an FTO Report, the SFDA will reject the request. A copy of the license issued by SAIP for the intellectual property agency must also be submitted along with the FTO Report.
If a valid Local Patent protecting the innovative product is identified during the FTO search, the generic company can then apply for registration of the generic product six (6) months before the expiry of the local patent. This allows the generic company to get its product ready for market as soon as the patent expires so that it can begin selling the generic drug as soon as possible after the patent expires. However, marketing of the generic product will not be allowed until after the expiry of the local patent.
When there is no Local Patent protecting the innovator product in Saudi Arabia
In such a case, the generic company is not required to submit an FTO when submitting a product registration application. If there is no Local Patent protecting the originator product in KSA, the SFDA will accept the product registration request. However, it is always advisable for companies to conduct their own due diligence to ensure that their proposed products do not infringe on any existing patents or intellectual property rights.
Pharmaceutical innovation is important because it can lead to the development of new and improved medications that can help treat and prevent a wide range of diseases. The regulatory environment plays a crucial role in fostering innovation by establishing rules and procedures for the development, testing, and approval of new pharmaceutical products. In Saudi Arabia, the SFDA is solely responsible for regulating the pharmaceutical industry, including the approval of marketing applications for both innovative and generic drugs. It is important for both innovator and generic companies to seek marketing approvals to comply with the relevant regulations and avoid patent infringement.
We encourage pharmaceutical innovators to file patent applications covering their drug products/ compositions inventions as the chances of securing patent protection for these are good, in addition to excluding the generic companies from marketing and distributing the drug in the market. More applications will also increase awareness around the importance of such inventions for innovator companies and will help in weighing the balance in favour of further protection for such inventions during any future reviews of the law by the competent legal authorities.