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    Finished Formulations with APIs Manufactured in Israel
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    Finished Formulations with APIs Manufactured in Israel

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    Registration of Biopharma Products using APIs Manufactured in Israel
    Kingdom of Saudi Arabia (KSA)

    The below version control table serves to document all updates made to the report. The purpose is to ensure the information is always accurate and up-to-date.

    Version Number
    Content Creation Date
    		Publishing DateSection(s) Updated & Reason(s) for Update
    V0
    07 February 2024
    		29 February 2024N/A (new report)
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    Table 1 - List of Abbreviations used in this document

    1. Drug Registration Process

    1.1 Drug Substance (DS)

    Marketing authorization applications (MAA) have been submitted in eCTD format since July 17, 2016. As per the e-CTD baseline requirements, Drug Substance is a mandatory requirement. Hence, the full Drug Substance Module is submitted and reviewed. 

    Ref: Baseline e-CTD submission requirements Version 1.1.

    Source: this information is based on Primary research and local expert knowledge. 

    Masking of the API vendor/Supplier information

    No, API information cannot be masked. As a part of the application form (Module 1) as well as Module 3, the information about the drug substance manufacturer should be provided to reviewing authorities, SFDA. 

    As a part of the application form, details of the drug substance manufacturer should be provided in the following format:

    Table 2 - Active Pharmaceutical Ingredient (API) Manufacturers

    Ref: Regulatory Framework for Drug Approvals Version 6.2 (DS-G-001-V6.2 /090705) issued dated 15 July 2008 implementation date October 2020.

    Source: Primary/Secondary research and local expert knowledge.

    1.2 Drug Product

    Saudi Arabia does not have official diplomatic relations with Israel and as per the trade policies, import from Israel is not favored. However, Saudi Arabia does not formalize the import restrictions on the pharmaceutical sector. Hence, regulations do not explicitly specify the import restrictions from Israel under product registration regulations, but in practice and on the ground, restrictions continue. 

    As per the import regulations, Medicines for Humans containing any goods from Israel are listed under restricted products and require permission before they are imported into Saudi Arabia. 

    Due to Boycott legislations in place as of Dec 2023 and the absence of formal diplomatic ties, there is a high probability that products containing sources of API from Israel will not be processed or registered. 

    Due to the evolving political challenges, it will likely be more difficult to register such products with sources from Israel. 

    Ref: SAUDI ARABIA - Import Guide 01 – Banned and restricted products Ed. 2.0

    Ideal route for access of such product in KSA

    None. 

    KSA has a breakthrough medicine program (for unmet needs) Dated 26 October 2023. Under this program, there is a requirement to declare the information about API and Drug product manufacturing sites. This may impact the approvals during the review process due to trade restrictions in the region and API sources from Israel. 

    In addition, the Product shall meet all four eligibility criteria listed below in table 3.

    Table 3 - Breakthrough Medicines Program

    Access pathway

    Eligibility criteria

    Process timeline

    Examples of brands that utilized this route

    Breakthrough medicines program

    All four criteria must be fulfilled to obtain a breakthrough medicine designation: 


    1. Target serious debilitating or life-threatening conditions with unmet medical needs. 


    2. The medicinal product is likely to offer major advantages over the methods currently used. 


    3. The potential adverse effects of the medicinal product that are considered to outweigh the benefits, allowing for the reasonable expectation of a positive benefit/risk balance. 


    4. The product is not registered at any regulatory authority at the time of submission of the designation request. 

    Anticipated timeline 6-8 months 

    None known to our knowledge.

    Ref:

    1. SAUDI ARABIA - Import Guide 01 – Banned and restricted products Ed. 2.0
    2. Breakthrough Medicine program Version 1.0 dated 26 Oct 2023.

    2. Regulatory Challenges / Mitigation Strategies

    None of the listed below options is possible due to the current political situation in the MENA region. 

    Name Patient Program (NPP) or Compassionate Use

    Considering the source of API from Israel, these options may not be viable for the following reasons:

    • For customs clearance, the exporter must provide the certificate from the country of origin stating the product being imported does not contain any part or materials originating from Israel. 
    • As per import regulations, Medicines containing any material from Israel are listed as restricted products. Hence, SFDA approval may be required before an Import permit is granted. This may delay the import license application overall or the application may be rejected.

    Orphan Designation / Approval by US FDA / EMEA

    In general, SFDA recognizes the approvals from the USFDA and EU countries and may allow the submission under other routes such as abridged or verification registration (Table 4).

    Table 4 - Verification or Abridged Registration Pathways

    Registration pathway

    Eligibility criteria

    Activity

    Submission requirements

    No of Reference country approval

    Process timeline

    1.  Abridged Registration 
    2. Verification Registration 
    1. The application must be submitted to the SFDA within two years from the date of approval by the reference agency. 
    2. The product does not need a more stringent assessment because of different local disease patterns and/or medical practices. 
    3. The product and its intended use (indications, dosage information, and patient groups (for a human product) or target animal species (for a veterinary product)) has not been rejected, withdrawn, or suspended by any drug regulatory agency for safety or efficacy reasons. 
    4. The location of the manufacturer should be in one of the following countries: USA, UK, Canada, Australia, Japan, Switzerland, Germany, France, Ireland, Italy, Spain, Portugal, Finland, Sweden, Norway, Denmark, Belgium, Netherlands, Austria, or Singapore.

    The level of manufacturing activity represents:

    • For Biologicals: Biological Substance and Finished Products.
    • For Pharmaceuticals: Finished Products (bulk) and Primary Packaging.

    Full e-CTD


    Module 2-5


    Module 1- local administrative requirements

    • Abridged Registration- Either of one drug regulatory agency such as USFDA or EMA
    • Verification Registration-product has been approved and marketed by both drug regulatory agencies-USFDA and EMA 

     

     

    • Registration through Abridged -60 working days
    • Registration through Verification- 30 working days.

     

    However, Due to current political situations and considering the product contains API sourced from Israel, such applications may not be accepted/will be rejected during the initial validation phase.

    A prior consultation with SFDA or formal request can be made to the HA prior to the submission sharing the lack of API documentation support and compliance of the drug product manufacturing site with EU GMP Guidelines (since the site is in Italy), the Health Authority (HA) at Saudi Arabia (SFDA) may consider evaluation and approval of the product. But it is subjected to SFDA’s discretion completely. (Low to Medium probability)

    Ref:           

    1. Regulation and Requirements for Import, Clearance and Export Ver 1.0 Dated 14 May 2015
    2. Registration according to Verification and Abridged Version 2.1 Dated Feb 2017.

    Source: Primary/Secondary research and local expert knowledge.

    Will there be an issue with registering this product under the fast-track application? 

    Fast-track registration pathways are available in Saudi Arabia. However, medicinal products containing materials from Israel are listed as restricted products in Saudi Arabia. Hence the review or approval under fast-track applications may also be impacted. 

    Source: Primary/Secondary research and local expert knowledge.


    Conclusion & Recommended Next Steps

    Considering that

    • the API source and DP release (QC testing) are being done in Israel, 
    • since Saudi Arabia follows the Arab League Boycott of Israel, and 
    • post the recent conflicts between Hamas (Gaza) and Israel, 

    registration of such Drug Products is unlikely to be permitted in Saudi Arabia. 

    However, since Saudi Arabia only restricts direct products manufactured in Israel, a secondary or tertiary boycott is not applicable for medicinal products, advised to reach out to SFDA to seek formal advice if the product in scope can be permitted or allowed for review.


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