Product registration can now be as fast as 30 days from file submission in Kingdom of Saudi Arabia (KSA)
Product registration can now be as fast as 30 days from file submission in Kingdom of Saudi Arabia (KSA)
Were you planning to expand your pharmaceutical company to the Middle-East, now it’s easier than ever. Product registration previously took more than 2 years prior to the new legislation in KSA. SFDA (Saudi Food and Drug Authority) amended now its process to work closely with reference authorities such as FDA (Food and Drug Administration) and EMA (European Medicines Agency).
New Chemical Entities and Biological products (except blood products and vaccines) can now be available for patients in KSA right after being approved by FDA and/or EMA through the Verification or Abridged Registration processes implemented by the Saudi Food and Drug Authority (SFDA).
The Drug Sector in the Saudi Food & Drug Authority (SFDA) has issued an amended guideline (initial one published early 2017) to help understand the Verification and Abridged registration processes for human and veterinary drugs.
What are the Verification and Abridged Registration?
The Verification Registration is applied when the product subject to registration has been approved and marketed by U.S. Food and Drug Administration (FDA) AND the European Medicines Agency (EMA). The registration approval is expected to be issued by SFDA 30 days after.
The Abridged Registration is applied when the product subject to registration has been approved and marketed by U.S. Food and Drug Administration (FDA) OR the European Medicines Agency (EMA). The registration approval is expected to be issued by SFDA 60 days after.
Therefore, depending on the approval status of your product, you either submit your file through the Verification Registration or the Abridged one.
The conditions to register your product in Saudi Arabia through Verification or Abridged process
-Product file must be submitted to the SFDA within two years from the date of approval by the reference drug regulatory agencies (U.S. FDA and/or EMA). If you fail to submit the file within this period, your product is no more eligible to Verification or Abridged Registration and will go through the previous regulatory pathway.
-Product and its intended use have not been rejected, withdrawn, suspended by any drug regulatory agency for safety and/or efficacy reasons.
The Verification and Abridged Registration are of a big significance in terms of regulatory and commercial outcome. Based on the research conducted by the MEALIS market access team, Saudi Arabia is one of the most attractive markets in the MENA region (Middle East and North Africa) in terms of pharmaceuticals and health care. It has a population of 33.5 million (1) and a healthcare sector that expected to reach $71.2 billion by 2020 (2). In addition to that, our local regulatory expertise and knowledge at MEALIS allows us to describe the early registration in Saudi Arabia as the key pass to other countries in the region since SFDA is considered a reference authority in terms of regulatory framework. This means, that it’s a strategic step to register in the KSA before expanding to other geographies in the MENA region. Previously, the registration procedure at SFDA was complicated, lengthy and challenging.
In conclusion, the Verification and Abridged Registration process adapted by SFDA is not only important to companies who are looking to launch their product in the Saudi market but also to MEALIS who has several successful experiences with SFDA registrations. With this process, MEALIS can help prepare the registration file, submit it and receive the successful registration certificate in the least amount of time and minimum costs.
- worldometers.info/world-population/saudi-arabia-population/
- http://saudigazette.com.sa/article/172230/Saudi-healthcare-market-to-expand-123-till-2020-reaching-$712bn-Report