Around 60
different national regulatory authorities are working independently to register
pharmaceuticals across the Middle East and North Africa. Several countries have
independent technical and administrative requirements, processes and procedures
for drug registration, and other formalities. Such conditions hinder the ease
of drug approval and commercialization demotivating the pharma companies which
might want to enter the MENA market. However, with the standard path of
approval and greater penetration of their drugs into the market in terms of
commercialization can help in reducing the limiting presence and assuring
pharma companies of better prospects while investing in MENA nations.
Moreover, the
guidelines and procedures are not up to international standards, which is again
a hindering factor in the market growth, as many pharmaceutical companies do
not want to compete with cheap generics, counterfeited medicines and low-profit
margins industries. This scenario is exact for pharmaceutical products like
biologics, biosimilars, and orphan drugs, whose neither the administrative
access is sufficiently regulated nor their pharmacovigilance activities are
effectively carried out.
However, the recent years have witnessed considerable efforts to harmonize regulatory requirements in terms of scientific content and presentation of data in the registration dossier, across various regions and countries. The region has now initiated some coordination and co-operation initiatives to kick start the pharma growth in the area. One such initiative is the governments’ operations in the Middle East to facilitate the ease of access to foreign companies offering innovative drugs, to entice firms to enter their market.
This ease of
access is facilitated in countries such as Saudi Arabia, Jordan, and Egypt,
which are putting their trust in regulatory authorities of established
pharmaceutical markets of Europe and USA- the European Medicines Agency (EMA) and
the U.S. Food and Drug Administration (USFDA). These countries are increasingly
referring to their guidelines and incorporating the same in own’s process. They
have initiated the process in which the regulatory agency of each of these
countries may fast track innovative drugs to be approved for local use in 30-60
days, if the drug has been previously approved by these trusted authorities, as
opposed to a previous full-year review.
Apart from this step forward, one of the crucial steps towards drug regulations in MENA is being done through the Gulf Cooperation Council (GCC). The GCC is a multinational partnership consisting of Bahrain, Oman, Saudi Arabia, Kuwait, the UAE and Qatar, who came together in 2014 with an aim to establish a drug price harmonization strategy intending to standardize drug prices within the region. The Global Cooperation Group (GCG) now includes the European Medicine Agency (EMA), the African Regulatory Harmonization Initiative (AMRH), the United States FDA (USFDA), the Association of Southeast Asian Nations (ASEAN), the Pan American Network for Drug Regulatory Harmonization (PANDRH), the Asia Pacific Economic Cooperation (APEC), Southern African Development Community (SADC), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Central Drug Registration is a unified GCC Health Council system for the registration of medicines, carried out by the Central Gulf Committee for Drug Registration. It aims to ensure the quality, effectiveness and safety of drugs, as well as the accuracy of information related to them. The system also ensures that medicines are manufactured in accordance with international standards. With the unification of regulatory processes, entry of foreign companies in the MENA market is expected to become easier.
For the African
countries of the MENA region, other steps are being taken to ease the approval
process of pharmaceuticals. Weakness in pharmaceutical regulatory approval
system of some North African countries such as Algeria, Morocco and Tunisia is
being taken into consideration. Efforts are being made to improve regulatory
processes to allow easier access to the market for essential and innovative
medicines. For example, Tunisia and Algeria are working towards the creation of
national registration guidelines for biosimilars which are expected to
accelerate the evaluation of biosimilars. Numerous important guidelines have
been issued in the last few years to reform the regulatory system and implement
efficient changes. The harmonization event in Casablanca also revived hope for
moving forward towards a more significant partnership and cooperation in the
region. These efforts are sure to improve the regulatory conditions of the MENA
region, making it one of the hottest pharmaceutical regions to be explored in
the coming years.
