October 2021 Monthly Newsletter

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.

Marketing authorizations are one of the most important assets for any pharmaceutical company, next to its products. Why is that the case? You can have the most life-changing medicine in your pipeline, but without marketing authorization, you won’t be able to sell it anywhere in the world.

But getting and keeping your assets on the market doesn’t come easily or cheaply. The health authorities charge fees for marketing authorization applications, as well as for variations, renewals, and annual fees for authorized medicines. Any company that wishes to put medicinal products on the market must know the costs of product submissions and product maintenance across the board to avoid any unforeseen expenses during the product lifecycle.

In our first article on the challenges of managing regulatory fees we spoke about the importance of managing all your assets – not only your medicines but also your marketing authorizations. Key to protecting your assets is knowing how to manage regulatory fees for each national competent authority. After all, missing or incorrect fees are one of the most common reasons why NCAs declare a submission invalid.

In our second article, we would like to share some tips from our Local Regulatory Affairs experts on fee payments in Portugal – another market where fee management can become a challenge for applicants.

As the largest country in South America, with a population over 200 million inhabitants, Brazil is an important market for the pharmaceutical industry. Before navigating the various regulatory pathways for obtaining MA for biological products, it may help to understand the commercial environmet in Brazil as well as its public health system.

According to a 2020 report from Sindusfarma, there are a total of 441 pharmaceutical manufacturers in Brazil, 89 (20%) of which are of international origin and 352 (80%) are Brazilian.

Sales of medicines in 2020 accounted for BRL 76.98 billion (US$15.02 billion), an increase of 11.40% over the previous year. This corresponds to approximately 2% of the world market, and makes Brazil the 7th largest global economy in revenue.

When the COVID-19 pandemic sent countries and communities into lockdown, one of the most severely impacted areas of healthcare was clinical studies. To safeguard patients and researchers, medical centers were forced to temporarily shut down many clinical trials.

According to one study, there was a substantial decline in the number of U.S.-based studies initiated between February 2020 and May 2020. While the drop in the number of new studies was less severe in non-US-based studies, there was also a sizeable reduction.

Even before the pandemic, however, there have long been challenges with the traditional clinical trial model, with an Institute of Medicine report noting that as many as 75 percent of investigators are unable to enroll the target number of patients.

With trials forced to adjust for COVID-19, the move to decentralized clinical trials (DCTs) has gained momentum. Over the past 18 months, the industry has witnessed a rapid uptake of DCTs and a willingness to embrace digital solutions to support patient-investigator interaction.

The journey to digital regulatory submissions has not been an easy one for Latin American countries. To understand the reasons why the transition to digital has been difficult, it’s important to consider historical barriers and specific local challenges – from an economic, social, cultural, and organizational perspective.

Latin America is considered to be the “most unequal and divergent region in the world” as a result of technology and socio-cultural disparities between cities and rural communities, as well as between countries. Countries across the region struggle with poor infrastructure, inadequate Internet connectivity, and inequalities in terms of access to electricity, widespread unemployment and high levels of adult illiteracy.