PHARMACEUTICALS monitor regulatory updates. The recommended strategy to save time and resources is identifying common requirements and patterns to leverage documentation, while also addressing the specific requirements of each country to prepare tailored dossiers for each authority.
How will these regulatory challenges be addressed during your discussions at CPHI Americas?
Latin America presents a significant growth opportunity for the industry, driven by factors like the region’ s substantial market value and projected expansion. However, regulatory fragmentation due to each country’ s unique history, economy and approach to healthcare and health policies presents a challenge. Discussions at CPHI Americas will focus on how regulatory convergence, reliance and recognition can boost market access, strengthen supply chains, and unlock growth opportunities for both regional and international stakeholders. Additionally, we aim to approach how Latin American manufacturers, alongside government agencies and US pharmaceutical companies, can collaborate to build a more robust and harmonised regulatory environment, ensuring safer products and unlocking growth opportunities for both regional and international stakeholders.
Nearshoring is becoming a hot topic in pharma- how is it reshaping supply chains in the region?
After disruptions in global supply chains due to COVID-19, companies are seeking to reduce their dependence on Asia, particularly China. Within the US-Mexico-Canada trade bloc, Latin America is emerging as a key player in supply chain diversification. This shift is attracting foreign capital into economies like Mexico, Brazil and Argentina. These countries offer a skilled workforce, and nearshoring fosters their continuous development, as well as the growth of infrastructure and economies.
It also integrates Latin America into global supply chains, and could position its pharmaceutical industry as part of the drug supply chains of developed countries. This development improves supply access for both the nearshoring and receiving countries.
What are the key advantages of nearshoring pharmaceutical production to Latin America instead of relying on Asia?
Nearshoring pharmaceutical production to Latin America enhances resilience by mitigating risks from global trade and geopolitical uncertainties. Geographic proximity allows greater responsiveness through shorter delivery times, lower logistics costs and more efficient oversight of production processes. Overlapping time zones enable quicker site visits and real-time communication with providers. Furthermore, nearshoring allows for facilitated alignment with regional regulatory standards, as Latin American countries often share similar requirements with the US, making compliance more streamlined.
What incentives are governments offering to attract pharmaceutical investment and manufacturing?
The first thing that comes to mind is tax incentives, such as tax exemptions, tax holidays and reduced corporate tax rates. Some countries also have free trade zones or special economic zones. Governments also offer funding opportunities, including co-financing for R & D, subsidies and low-interest loans for establishing manufacturing plants. Additionally, Latin American countries are improving regulatory frameworks to reduce time-to-market. This includes the implementation of digital processes to streamline operations, enhance efficiency, transparency and predictability. Brazil has introduced regulatory sandboxes this year— experimental regulatory environments where rules can be temporarily adjusted to allow flexible exploration of new technologies.
What advice do you have for pharmaceutical companies considering Latin America as a nearshoring destination?
Pharmaceutical companies considering this should be aware that relocating production lines is complex and time-consuming, involving legal product regularisation, infrastructure development, securing permits and workforce acquisition. We know that one of the main drivers of nearshoring is faster market access; so avoiding legal and compliance setbacks is crucial. Companies must understand the specific regulations of each market, as they vary in legal, tax, and intellectual property standards. We highly recommend building local partnerships to navigate these differences effectively. Additionally, trade agreements and government incentives can help reduce operational costs and facilitate entry into regional markets. However, it is essential to give careful consideration to currency volatility and inflation.
What insights can attendees expect from your participation at CPHI Americas, and why is this an important event for the industry?
At CPHI Americas, attendees can expect to gain valuable insights into the challenges and opportunities within the evolving regulatory landscape for pharma nearshoring in Latin America. We will focus on regional regulatory convergence, aligning regulations with global standards, and exploring reforms to boost local manufacturing without compromising quality and safety. We will also highlight the importance of collaboration between public institutions, industry leaders, and regulatory bodies to drive innovation and improve market access. CPHI Americas is a must-attend for anyone looking to navigate Latin America’ s dynamic regulatory and commercial landscape. If you have any questions, please speak to me there. ●
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