Dr Ivan Fisher, Vice President, Head of Commercialization at G&L Scientific, looks at the regulatory opportunities and challenges in the Middle East and North Africa (MENA) region.
Spanning from Morocco to Iran and down to Sudan, the MENA region is one of the fastest-growing and exciting markets in the regulatory industry.
The global pharma market is currently valued at over $1tn and in 2016 the MENA region was estimated to be worth around $36bn alone. Today, it boasts one of the fastest growth rates in emerging markets, with an annual growth rate of between 7 and 10 per cent — almost double the global growth rate of 4 to 6 per cent.
Given the sheer size of the area, the number of countries, and the melting pot of languages, cultures, economics, demographics, and laws found within it, it is no surprise to find a broad range of processes, policies, and approaches regarding drug registrations.
This can be resource-sensitive for many potential investors. However, changes are ongoing and significant progress has been made across the region, making it a considerably more attractive proposition for regulatory and associated industries.
From local regulatory authorities establishing appropriate procedures for authorization and maintenance of marketing authorization of medicinal products utilizing International Council for Harmonisation (ICH) guidelines to improvements in legislation and procedures, steady progress is being made.
That said, and given the range of differences, there is still much work required to fully harmonize requirements and simplify the various processes and procedures.
Indeed, there have been renewed calls to streamline the system using a World Health Organization Collaborative Procedure for Accelerated Registration (WHO-CRP) like that being utilized throughout Africa.
This system has reduced the time and costs of registration and helped improve patient access to vital medicines by incorporating work-sharing and regulatory reliance and removing repetitive and low value-added practices in favour of a single registration dossier for multiple countries.
The benefits of its implementation are being felt across Africa as well as other resource-limited countries. It is thought that extending it across the MENA region would simplify registration processes, speed up market access and attract investment from major regulatory agencies.
These challenges aside, the region has great potential within the regulatory environment. As regulatory bodies realize the need for urgent reforms and begin to bring them to fruition, the benefits in reshaping the regulatory environment will be matched by the positive implications it will have for patients in need living in the region as medicines become more freely available and at a much faster rate.
Reshaping the regulatory environment through simplifying and unifying processes across the MENA region will be integral in unlocking the plethora of untapped opportunities it has to offer as well as improving patient care and access to innovative, life-changing medicines.
As great, positive change takes place, the eyes of the world should now be firmly fixed on MENA.
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