Similarities, Differences, and Opportunities in MENA Markets
The Middle East and North Africa are becoming increasingly important pharmaceutical markets, leading many companies to seek support in countries in the region. Across the MENA region*, the pharmaceutical market was valued at $36 billion in 2016 and in recent years has seen growth of 10 percent, well above global growth of 4 to 6 percent.
However, with countries across the Gulf states, Israel, and North Africa, there are many different regulatory requirements and expectations for companies to manage. The good news for companies is there have been increasing efforts to standardize and streamline processes, but many challenges and inconsistencies remain.
Egypt – the region’s largest market
As one of the most densely populated countries in the region, with more than 100 million people and patented drug sales of around US$200 million (170 million euros), Egypt is an important market for pharmaceutical companies.
However, from a regulatory point of view, Egypt’s guidelines are not detailed and the authorities demand a wide variety of documentation to support a submission. For example, when ProductLife Group’s team of MENA regulatory experts submit a variation or a novel submission to the authority, we provide the global master documentation, but must also prepare other documentation, such as legalized/notarized documents, declarations made to the authorities, company clarification letters, and separate information on the product composition.
One significant recent change in Egypt is the fact that guidelines are now issued in English as well as Arabic, and the authorities are looking to accept more documentation, such as CMC documents, in English. However, companies will still be required to submit affiliate authorization letters in Arabic. A further challenge for companies is that the affiliate must make an appointment with the authority to make the submission since face-to-face communication is a requirement.
Israel – a market apart
The Israeli regulatory authorities have distinctly different requirements to other countries in the region. For example, all leaflets, cartons, and packaging must be completed in three languages. Israel’s requirements for registration very similar to those in the EU with some additional specific requirements. Submissions can be made via email, CD or hardcopy, depending on the scope of the submission. The company is required to appoint a qualified person, who must be a pharmacist assigned by the regulator and located in Israel.
Israel does largely accept EU variations and, in fact, has an agreement with the EU whereby each recognize the other region’s GMP inspection conclusions, manufacturing and import authorizations, certification of conformity of batches, and official-control-authority batch release. However, the Israeli regulatory authorities often ask additional questions from the marketing authorization holder and look for more proof or substantiated clinical documents from the company headquarters.
The Cooperation Council for the Arab States of the Gulf (GCC)
The six countries of the GCC – Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Kuwait, and Oman – have achieved significant harmonization of drug registration processes, including approval through the centralized procedure for all pharmaceutical products in the region. In addition, most GCC countries now accept eCTD submissions, although Oman still accepts submissions in other formats.
However, there are differences and complexities in some markets. For example, in Bahrain, the local representative is expected to get an appointment with the authority and submit the file via a CD or using data transfer. Companies are given a single day in the month to do their submissions, and can only make five submissions in each appointment.
There are also several temporary closures in some GCC markets. For example, the Kuwait regulatory authority announced a temporary suspension of all applications from July 4 until September 5, 2021, while Qatar recently issued notification that new drug applications would not be accepted between August 8 and August 31. These short-term closures are likely because the competent authorities in these markets were working with limited resources during the COVID-19 pandemic and are now struggling to deal with the large back-up in submissions. Temporary suspension gives the regulators time to work through the backlog.
Addressing MENA requirements
While there is no single way of managing regulatory submissions in MENA, there are some similarities across all MENA countries. The company’s regulatory representative must be both present and a citizen of the country in order to submit. Importantly, most countries in MENA have made concerted efforts to update or introduce stronger patent laws, including adopting international practices in many cases. Trade agreements between MENA countries and Europe and the U.S. are becoming more common, making it easier for pharmaceutical companies to expand business opportunities.
ProductLife Group has expertise across all MENA markets, providing regulatory support from our offices in Turkey and from our experts in Tunisia. In addition, we have partners in each MENA country to ensure regulatory submission requirements are met, and to help our clients expand their reach into these important and rapidly growing markets.
*A List of MENA Countries
Countries defined as MENA vary depending on the source. The United Nations Human Rights Office of the High Commission classifies the following 19 countries as within the MENA region:
GCC — comprising Saudi Arabia, Kuwait, UAE, Oman, Bahrain, and Qatar
Other Middle East countries, including Syria, Lebanon, Jordan, Occupied Palestinian Territory, Iran, Iraq (including Kurdistan), Yemen and Israel
North Africa, including Egypt, Algeria, Morocco, Tunisia, and Libya.
For submission purposes, Turkey is also considered part of the MENA region.