The life sciences industry in MENA is in the midst of a transformation. A combination of new technologies, changes in the market, and rapidly evolving regulatory requirements are driving significant changes in how drug companies in MENA operate. And it is clear that this period of rapid change will continue into 2024.
Here is a breakdown of the big trends and changes that will drive the rapid evolution of the life sciences industry as we look ahead.
Increasing Regulatory Standards
Addressing regulatory requirements in each country they operate is always the foundational requirement for drug companies. As regulatory bodies in MENA countries add new requirements and increase enforcement, navigating the regulatory terrain across the region is a major challenge for life sciences companies.
Evolutionary changes in the regulatory framework in 2024 will profoundly impact operations. Below are some significant events:
- The Saudi Food and Drug Authority (SFDA) joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a member, aiming to harmonize inspection procedures worldwide, facilitating cooperation and networking between pertinent authorities and regional and international organizations.
- Jordan Food & Drug Administration (JFDA) submitted a complete membership application to PIC/S in 2021 and is close to becoming a member.
- Saudi Food and Drug Authority (SFDA), the regulatory authority in Saudi Arabia, announced in October that they had achieved maturity level four in the WHO’s model for medicines and vaccine regulation. This is a strong indicator of the Saudi commitment to continuing to drive increased quality and adherence to standards in the life sciences sector.
- On 22 September 2023, the Egyptian Drug Authority (EDA) applied for PIC/S pre-accession.
- The US FDA established a program to promote quality management maturity (QMM) at drug manufacturing establishments. The QMM program encourages drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.
While it is impossible to say what’s next and in which country, what is certain is that every regulator in the MENA region will continue to evolve their regulatory framework, which means continuing challenges for companies operating across multiple countries.
We see that the companies that look at the rapid evolution of regulatory changes as an opportunity, not a threat, are those that thrive. Of course, tracking and complying with a rapidly evolving set of regulations is a challenge, but smart companies are investing in the systems they need, such as Regulatory Management Systems, to address the changes effectively. These systems manage documentation and correspondence, identify gaps, and ensure every required interaction is tracked to completion.
Accelerating Digital Transformation in Life Sciences Operations
Digital transformation may be overhyped, but the reality is that new technologies are reshaping the core of life sciences operations. In managing the supply chain, automating the manufacturing process, and ensuring compliance with regulatory requirements, new and emerging technologies like AI allow small businesses to grow faster and larger organizations to become more efficient.
We see this in many business areas, but the manufacturing function is the showcase. Automated functions and equipment are being connected in this area, allowing effective monitoring and tracking of complete, end-to-end processes.
While the impact may be measured in production metrics, the real payoff is in quality. That’s because while manufacturing automation can also oversee your entire production process, the real-time collection of data and analytics means that minor to severe problems can be detected early, remediated, and used to elevate ongoing performance.
Increasing Skills Requirements for the Workforce
The changes described above drive a need for a more knowledgeable, skilled, and flexible workforce. Gone are the days when people just needed to do what they were told. Today, we need collaboration and problem-solving skills at every level of the organization and employees who get the big picture, not just the task at hand.
According to McKinsey:
“These macro trends are generating major shifts in the skills the operations workforce must have and forcing companies and their employees to accept new ways of working. Occupational profiles are changing too: some jobs are disappearing as a result of automation while entirely new jobs are emerging.”
Similarly, research by the World Economic Forum indicates that organizations must prepare the workforce for this transition, retool their educational systems, and invest in training and lifelong learning to create a mobile workforce that can benefit from the opportunities the fourth industrial revolution has been creating.
Companies are preparing by investing in training management and tracking systems. These systems track employee skills, identify training gaps, and manage training documentation to ensure that every staff member is progressing on a journey to build their skills.
As we venture into 2024, life sciences companies in MENA face an environment characterized by rapid changes and disruption. While the challenges may seem daunting, the reality is that every company has a unique opportunity to leverage technology to address the changes in the environment and to drive growth and innovation. By staying attuned to these trends, companies can navigate the changing landscape and emerge as the next generation of leaders in the maturing pharma market in MENA.