Finished Formulations with APIs Manufactured in Israel

Registration of Biopharma Products using APIs Manufactured in Israel
United Arab Emirates (UAE)

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.

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 October 1st, 2017. In the case of New Chemical Entity (NCE-I), Biologicals, and Biosimilars (B), all the CTD Modules are required as per the ICH CTD structure, and drug substance is part of it. Hence, the full Drug Substance Module is submitted and reviewed. 

Ref: https://mohap.gov.ae/en/services/registration-of-a-conventional-pharmaceutical-product

Source: MOHAP website 

Masking of the API vendor/Supplier information

No, as 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, MOHAP. Hence the API /API vendor information cannot be masked.

Ref: https://mohap.gov.ae/en/services/registration-of-a-conventional-pharmaceutical-product

Source: MOHAP website

1.2 Drug Product

Officially, there are no such legislations or regulations that would restrict the registration or import of pharmaceutical products/products containing any material sourced from Israel. As far as the finished product is being imported from Italy, it is acceptable.

The UAE repealed its boycott law by issuing Federal Decree Law No. 4 of 2020 and abolishing Federal Decree Law No. 15 of 1972 concerning the Arab League Boycott of Israel.

However, considering the ongoing conflict and condemnation by most of the Arab countries, some challenges are definitely expected.

Note: UAE has signed the Abraham accords since 15 September 2020. 

Ref: Abraham Accords Peace Agreement: Treaty of peace, diplomatic relations, and full normalization between the United Arab Emirates (UAE) and the state of Israel.

Ideal route for access of such product in UAE

New product registration can follow the Conventional Route for Innovative products using fast-track review.

Table 2 - Conventional Route for Innovative Product Registration in UAE

Ref:      

1. https://mohap.gov.ae/en/media-center/news/25/1/2018/minister-of-health-and-prevention-issues-ministerial-decree-for-the-registration-of-innovative
2. National Drug Policy UAE

Source: MOHAP website- https://mohap.gov.ae/en

2. Regulatory Challenges / Mitigation Strategies

Since UAE accepts products with API sourced from Israel, no challenges as such are expected. 

Alternatively, the MOH has enabled a process to import unregistered medicines in exceptional circumstances, namely:

1. Medicines to be used in emergency situations necessary for the continuation of patients’ lives;
2. Certain drugs that are not available in the local market and cannot be dispensed in hospitals, such as heart cancer treatments;      ‪
3. Other pharmaceuticals which have not yet been regulated by the Ministry;       ‪
4. Medicines required by health institutions affiliated with government or semi-government agencies & entities, which have been imported based on purchase orders from the government or semi-government hospitals that are affiliated to Abu Dhabi Health Authority or Dubai Health Authority or Ministry of Defence or Ministry of Interior;
5. Registered medicines that are not available at the official deal or not available in the market;
6. Drugs whereby registration has been canceled at the request of the official agent due to lack of local market demand;             ‪
7. Unregistered narcotic or psychotropic drugs, used in specialized hospitals (private & governmental).

Accordingly, some hospitals that are affiliated with the Abu Dhabi Health Authority or Dubai Health Authority are allowed to import unregistered drugs into the UAE subject to approval from the MOH. The application to import unregistered drugs in such circumstances must be detailed and specific in order to gain approval. As such, the quantity of the imported medicines shall be limited to the hospital capacity and the number of existing and/or expected patients, and under no circumstances are they able to supply non-registered medication outside the hospital. The MOH has the full authority to refuse an application to import unregistered drugs, amend the quantities, or issue a conditional or unconditional acceptance of such requests and quantities.

The MOH has set a number of conditions with regard to the import of unregistered drugs: 

1. The application to import unregistered medicines shall be made by a registered agent in the UAE, or through a licensed medicine store or an authorized distributor (this condition does not apply to the import of unregulated pharmaceutical products, such as chemicals used in laboratories and other medical materials used in nuclear medicine in government hospitals);
2. The medicine must be registered in the country of origin or an approved country such as the USA, Europe, or the GCC. If the medicine is registered in one of the GCC countries or by the European Medicines Agency or US FDA, then obtaining the approval from the MOH to import such unregistered medicine in the UAE will be easier.
3. The application must be made from the Medical Director of the Hospital/Head of the concerned department of the purchase order and contain:
   1. A Letter of Undertaking from the hospital to use the product and bear all the responsibility for such use;       ‪
   2. A registration certificate of the manufacturing company of chemical products; and   
   3. A valid analysis certificate of the product from the plant.       ‪
   4. Any hospital/entity which imports unregistered medicine is liable for such import and use of that medicine.  This legal obligation is referenced by the condition above requiring a Letter of Undertaking from the hospital to use the product and bear all responsibility of such use. The sanctions stated in Law No. 4 of 1983 concerning the Profession of Pharmacy and Pharmaceutical Institutions shall be applied in case of any violation of the terms.

Ref: https://www.tamimi.com/law-update-articles/importation-of-unregistered-drugs-in-the-uae

Orphan Designation / Approval by US FDA / EMEA

In general, the UAE recognizes the approvals from the USFDA and EU countries and may allow the submission under other routes such as fast track approval. 

Since UAE accepts products with API sourced from Israel, no challenges as such are expected. 

Source: Primary/Secondary research and local expert knowledge.

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

No, Effective 22 January 2018, the Ministry of Health, and Prevention in the United Arab Emirates ('MOHAP') issued a Ministerial Resolution that provides for the fast-track registration of 1) 'drugs that contain an entirely or partially new active ingredient and whose owner holds a patent' ('Innovative Drugs') and 2) 'drugs that are used for treatment, diagnosis or prevention of rare diseases' ('Orphan Drugs').

An Innovative Drug or Orphan Drug can be included in the fast-track process following a positive opinion issued by one of several specific accredited international regulatory bodies, even if final approval has not yet been granted by such regulatory body, provided, however, that the certificate of pharmaceutical product ('CPP') will be submitted to MOHAP once available.

Ref:      

1. https://mohap.gov.ae/en/media-center/news/25/1/2018/minister-of-health-and-prevention-issues-ministerial-decree-for-the-registration-of-innovative
2. National Drug Policy UAE

Source: MOHAP website - https://mohap.gov.ae/en