Expediting access through Reliance Pathways: MENA region

Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities.  

Recently, several National Competent Authorities (NCA) in the Middle East North Africa (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of highly needed innovative and/or life-saving drugs when no other therapeutic alternative exists. 

  

Regulatory challenges in the MENA region 

Regulatory procedures for drug products are often lengthy and complex, thus resulting in delayed patient access to important medicines. This issue is of more significance in the MENA region for several reasons: 

  • The filing of new drugs in the MENA region is done almost exclusively after they are filed, reviewed and approved in other regions/countries, typically in the European Union, United States of America, Japan, etc. Also, a Certificate of Pharmaceutical Product (CPP) is required to file new pharmaceutical products in the region; 
  • There is a lack of dedicated Regulatory Agencies for accelerated access through Reliance Pathways, resulting in local health authorities experiencing competing priorities; 
  • Constraints in human and material resources. 

Having Reliance Models already exist worldwide, MENA region regulators have started to work in close collaboration with the Industry to face the current situation. Regulatory procedures, namely Verification and Abridged versions, have started to be adopted and implemented since 2017. 

 

Verification and Abridged reviews definition 

Verification review

The Verification procedure permits a drug to be marketed locally once it has been approved by foreign stringent regulatory authorities (SRA)It is an administrative review, based on CPPs issued by reference authorities, Assessment Reports and/or GMP inspection reports. 

For example, Verification Registration in Saudi Arabia requires that the human medicinal product must be approved and marketed by both EMA and US FDA as selected drug regulatory agencies. 

 

Abridged review

This procedure also relies on SRA assessment and approval but includes an abridged independent review of parts of the dossier. The review is done based on Assessment Reports, GMP inspections reports and/or CPPs of reference authorities along with a part of CTD (Module 3). 

For example, Abridged Registration in Saudi Arabia requires that the human medicinal product must be approved and marketed either by EMA or US FDA.  

 

MENA Countries with Implemented Reliance Pathways  

The following countries in the MENA region have already implemented the accelerated / reliance pathways: 

Country Implementation Details
Saudi FDA The initial circular was issued in October 2016 with February 2017 as the implementation date.

A detailed guideline followed in February 2017.

Egypt The decree 820/2016 of January 2017 was implemented in April 2018 with a detailed guideline.
Jordan The Verification Review was announced in February 2017 and a detailed guideline was issued by the JFDA in July 2017.
United Arab Emirates Implementation with the issuing of a ministerial decree in January 2018.
Kuwait The decree issued in April 2018 mentioning an approval timeline of 6 months.
Bahrain The memo issued in January 2018, a conditional license with a 1-year validity can be issued 1 month after the application date.
Eligibility Criteria, Procedure & Timeline 

The main eligibility criteria for applying for a Verification or Abridged review in the cited countries are generally quite similar. Nevertheless, some countries have differences in timelines and require specific conditions to be fulfilled. 

Saudi Arabia: 

To assist applicants with the Verification and Abridged registration, the Drug Sector at Saudi Food & Drug Authority (SFDA) has published a document named Registration According to Verification and Abridged, current version 2.1, providing details on the eligibility criteria, the submission requirements and the procedure of submission. A summary is in the table below. 

Main eligibility criteria Procedure Timeline Additional conditions/ remarks
US FDA or EMA approval Abridged 60 days
  • Innovative products only: NCEs, new biologicals
  • Submission to SFDA should be done within 2 years of approval by the reference agency
  • The confidential Assessment report is required
  • No product withdrawal, rejection or suspension decision related to the efficacy or safety by any regulatory agency
  • Manufactured in a reference country listed in the SFDA guideline.
US FDA and EMA approval Verification 30 days

 

Egypt: 

Before implementing the Verification and Abridged regulatory procedures, Egypt already had certain Reliance practices. Upon filing, products originating and marketed from reference countries are exempted from the manufacturer inspection and from submitting parts of the dossier, i.e., clinical and non-clinical databy the Egyptian HA. An overview of the reliance pathways in Egypt is given in the table below: 

Main eligibility criteria Procedure Timeline Additional conditions/ remarks
US FDA or EMA approval Abridged 60 days
  • Launch within one year of approval in the reference country.
US FDA and EMA approval Verification 30 days

Jordan: 

Main eligibility criteria Procedure Timeline Additional conditions/ remarks
US FDA or EMA approval Abridged 90 days
  • Applicable for the product’s lifecycle management as well.
US FDA and EMA approval Verification 60 days

United Arab Emirates: 

Main eligibility criteria Procedure Timeline Additional conditions/ remarks
US FDA or EMA, Swiss Medic, TGA, PMDA, MHRA, HC approval Verification 30 days
  • US FDA or EMA, Swiss Medic, TGA, PMDA, MHRA, HC approval
  • The pricing step follows the Verification procedure

 

It is no doubt that Reliance pathways, such as the Abridged and Verification procedures adopted in the last years in the abovementioned MENA countries, offer many benefits to the industry and patients: 

  • Shorter approval timeframes lead to better access to innovative medicines for patients; 
  • Resources managements is optimized for regulatory agencies. 

However, models implemented so far could still be improved as different challenges are usually encountered in real practice. These challenges are mainly related to:

  • Pricing procedure after approval
  • Transparency and unpredictability of timelines
  • Electronic systems functionality
  • Product testing requirements
  • Provision of confidential information, etc.

With the expectation of seeing these topics addressed in the ongoing dialogue between all relevant parties, it is also anticipated that these reliance models will be amended and replicated in all MENA region countries. 

 

If you want to get more information on this or other Regulatory topics related to the MENA region, contact us!