Export support MENA Sub-Saharen African region
The Middle East and North Africa are becoming a catalyst for potential development and lucrative growth in the pharmaceutical market. Leading companies are seeking to register their products in the region.
However, the companies have to manage different regulatory requirements and foremost local standards even if these countries are increasing efforts to simplify and standardise the processes.
First of all, the companies’ registration is part of the common regulatory requirements in several Middle East and North African (MENA*) countries:
- The Middle East countries will require a separate company submission with a specific registration file. Some countries like Saudi Arabia, Kuwait and Qatar are still accepting parallel submission of both company and Marketing Authorisation Application, while the remaining countries (UAE, Oman, Bahrain, Jordan and Iraq) require complete company registration before the MAA submission. This can have an impact on the overall registration procedure timelines. Therefore, companies should consider this registration step in those countries to plan product approval timelines and launch activities correctly.
- North African countries do not require a separate company registration for the marketing authorisation holder (MAH) or the manufacturing site. However, these countries will ask for key documents related to the manufacturing sites involved in the drug product manufacturing and batch release sites during the product registration procedure (like international GMP inspections/certificates from leading health authorities and agencies).
Company file review will take place in parallel with the product registration review with no impact on the overall registration procedure timelines.
With regard to product registration, the regulatory Marketing Authorisation Application submissions in MENA and Sub-Saharan African countries** are not yet standardised but there are some similarities which could make the registration process easier for the pharmaceutical companies in those regions.
- The countries of the Gulf Cooperation Council (GCC): Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Kuwait, and Oman, have achieved an important harmonisation of drug registration procedures. The centralised process in the GCC has several advantages regarding direct submission, coordinated documentation and approval for all pharmaceutical products. In addition, most of GCC countries now accept eCTD submissions.
- In Sub-Saharan African countries, there is progressive improvement in the regulatory capacity of the National Medicines Regulatory Authorities (NMRAs), which is improving the evaluation process and registration of pharmaceutical products.
For all business procedures and registration activities in MENA and Sub-Saharan African countries, the pharmaceutical companies must be represented by a local representative who will ensure the administrative and regulatory approaches for the Marketing Authorisation Application registration from a valid country of origin marketing authorisation (MA), renewing the MAs and negotiation of prices and reimbursements with certifying bodies.
*A List of MENA Countries:
19 countries are generally considered as MENA countries:
- North Africa, including Egypt, Algeria, Morocco, Tunisia, and Libya;
- GCC: Saudi Arabia, UAE, Kuwait, Qatar, Oman and Bahrain;
- Other Middle East countries, including Syria, Jordan, Lebanon, Palestine, Iran, Iraq, Yemen and Israel;
**Sub-Saharan African countries including French and English-speaking countries.