Around the Globe

Jordan FDA Adopts Reliance Review Model
Regulatory Environment Dynamics in the Middle East Region
Inas Chehimi
Novartis Pharma Services AG

017 and 2018 were transformational years in the regulatory dynamics of the Middle East, specifically with reforms targeting the innovative molecules review process, and we have witnessed issuance of new regulations adopting the Reliance Review Model in several countries within this region.

The principle of the Reliance Review Model is in line with the WHO recommendations to optimize resource use and avoid duplication of efforts; in general, review on the basis of Assessment Reports, GMP inspection reports, and/or Certificates of Pharmaceutical Products (CPPs) of the reference authorities is encouraged. Our July Global Forum article previously discussed details of this Model.

This Reliance Model dynamic was kicked off in the Middle East region by the Saudi FDA, and was later adopted by Health Authorities in Egypt, Jordan, and the UAE.

Jordan FDA (JFDA) stands among the early adopters of this model, immediately after Saudi Arabia. In February 2017, the JFDA published in their official Journal a brief note about the verification/abridged procedure (90-day review process), followed by the detailed final guideline published in July 2017.

In June 2019, JFDA published an updated version of the reliance model guideline where they added the abridged model in addition to the previously adopted verification model, as described below:

  • Verification procedure: 60-day review process conditional on approval issued by both EMA and FDA as main eligibility criteria.
  • Abridged procedure: 90-day review procedure conditional on approval issued either by either EMA or FDA as main eligibility criteria.
  • The reliance model in Jordan is applicable to new molecule registration, new indications, and to lifecycle maintenance activities (e.g., variations and renewals).
  • There is also a clause related to the retroactive effect of the guideline through which a product fulfilling these criteria and submitted via the normal pathway can be switched to the Abridged or Verification procedure.
  • In both the Verification and Abridged procedures, the public assessment report from EMA or FDA is the reference review document of JFDA, and its submittal with the marketing authorization application is mandatory.

At the beginning, in their 2017 guideline, JFDA adopted the verification model only where they mandated that the product should have both EMA and FDA approval as prerequisite to be eligible for the (60- or 90-day) fast track procedures; this lasted till June 2019, when the new guideline was published to reflect both procedures as applicable.

We have been observing the implementation of the reliance model in Jordan for the last eight calendar quarters (two years) and have noticed that the average review timeline in both procedures (Verification or Abridged) was three to five months. For the JFDA, this is a significant milestone compared to the standard procedure where the average review timeline was 18 months for small molecules and 24 months for biological products.

One of the key success factors of Jordan’s implementation of the reliance review model is JFDA’s openness to collaborative dialogue with the pharmaceutical industry. Much like the approach to new guidelines taken by EMA and FDA, JFDA published the draft guideline and welcomed comments before its adoption; moreover, JFDA held several face-to-face meetings with local industry experts to discuss comments and feedback received on the draft guideline. This approach is an ongoing continuous process where both JFDA and industry representatives continue to work together as true partners on maximizing the opportunities of the reliance model implementation and overcoming challenges faced by both sides.

In a recent discussion with the local industry representative group, for example, we have learned that the main areas of improvement on which they must focus with JFDA are the laboratory analysis step and the pricing step of the review process.

External observers can clearly notice that implementation of the reliance review model in Jordan provides one of the most successful examples in the Middle East region which truly reflects the vision of JFDA and will absolutely pay off for Jordanian patients.

An upcoming article will share more details about regulatory dynamics in UAE and Egypt.