Trends and Challenges Facing MENA Pharmaceutical Sector

Trends and Challenges Faced by MENA in Pharmaceutical Products Registration

The pharmaceutical products registration in uae markets in the Middle East and North Africa are shaped by various possibilities and challenges. Challenges are growing, although there is variation at the country level as well as expectations for slower growth tied to a gradual recovery in the oil sector affecting pharmaceutical spending.

However, experts caution that to reach their potential, several changes and challenges must be addressed in this region. While manufacturing is meeting standards to reach cGMP compliance, many facilities or processes are not yet acceptable for EU or FDA approval. There are also views that some of the emerging technologies are not available in the region and affect local experience in the sector.

As a result, consumer products will grow with the economies gentrifying, while antibiotics, cardiovascular generics and GI types will still be the biggest product classes.

The information gathered from various sources regarding the key challenges and trends in the MENA region for the Pharmaceutical industry are as follows:

1. Challenges in the Pharma Industry:

Pharmaceutical products registration in UAE regulations and guidelines are stricter and more numerous in Saudi Arabia and other Middle Eastern countries than almost anywhere else in the World

•  Keeping up with the Legislations: Regulators are introducing wider and more numerous regulatory changes to protect the public and the industry’s long-term security.

• Regulatory compliance: Regulatory compliance is made harder by the nature of pharma companies’ data, leading to missed details, deadlines, and processes.

• Disconnect between regulators and international bodies: The Development of new regulations often occur in isolation without international pharmaceutical companies developing sufficiently deep connections with regulators of their target audience’s host country

• Unified pricing system: The unified pricing system for pharmaceuticals, adopted by all GCC states, prohibits both global and domestic companies from increasing prices for pharmaceuticals.

Multinational pharmaceutical companies cite lengthy drug approval times, flimsy intellectual property protection and opaque government tender processes as some of the key regulatory challenges of working in the region.

Most Middle Eastern pharmaceutical companies do not avail the details of legislation for pharmaceutical products registration in UAE to the public, and available legislation for pharmaceutical products registration is only available in the local language, making comprehension difficult for MNCs.

2. Trends in the Pharma Industry:

• Rollout of compulsory health insurance schemes for drug product registration.

• Generic substitution and medical tourism are expected to continue shaping the Pharma brand registration market.

• Better IP protection regulations are being refined across the Middle East to comply with the Trade Related Aspects of the Intellectual Property Rights (TRIPS) agreement of 2012.

• New drug application waiting times are being reduced to encourage more international pharma involvement in pharmaceutical products registration. 

• The Saudi Arabian Government's decision of 100% ownership trading licenses to global firms. In mid-2016, Pfizer was the first pharmaceutical company to win a license

• Strengthened Pharmacovigilance (PV) systems and initiatives are emerging in GCC countries to allow for the more effective reporting and prevention of Adverse Drug Reactions (ADRs).

• In the near future, outsourcing, vaccine and biotech development, and harmonization will continue to trend in the region.

• For both multinationals and SMEs wishing to enter the market, this is usually the best option, as many organizations do not wish to have established assets everywhere.