The pharmaceutical industry has valuable organizations and advocacy groups that work for the benefit of its members and, in turn, for patients. We are beginning an occasional series that offers insight into some of these organizations, along with the aims of each. For our first entry, we examine the European Fine Chemicals Group (EFCG) and its parent organization, the European Chemical Industry Council (Cefic). SK pharmteco is proud to be a member of both organizations.
Background and Benefits
As the voice of European fine chemicals, EFCG is a non-profit international sector group within Cefic, the Brussels-based European Chemical Industry Council. EFCG is celebrating its twentieth anniversary in 2024. Cefic dates to 1972 and represents large, medium, and small chemical companies across Europe. These chemical manufacturers provide 1.2 million jobs, accounting for ~14% of the world’s chemical production. Cefic is a partner of the European Union. Additionally, Cefic is an active member of the International Council of Chemical Associations (ICCA).
A “sector group” of Cefic, EFCG’s focus areas are fine chemicals used for pharmaceutical applications or agrochemicals. For European-produced APIs, EFCG promotes “EU authorities to encourage the removal of barriers such as regulatory or tariff-based hurdles in order to promote the entry of European products in higher growth non-EU markets.” Building a strong relationship with the US FDA towards a joint regulatory system and a mutually recognized inspection system for manufacturing sites “would facilitate the entry of European manufactured APIs into the US pharmaceutical system, which is the biggest and fastest growing pharmaceutical market in the world.”1
The group is also advocating that EU member states strengthen their cooperation to build a common regulatory harmonized system.
Many APIs for the most developed market (the United States) come from Europe –and the need for a robust, integrated, streamlined, and secure supply chain is critical. To that end, the EFCG has been actively working to address the issue of drug and active pharmaceutical ingredient (API) shortages across Europe. Here are some of the positive impacts of the EFCG’s efforts:
- Raising Awareness: The EFCG and the Bulk Pharmaceuticals Task Force (BPTF) have alerted regulatory authorities about worsening medicine shortages. They have been actively engaging with them and relevant stakeholders to propose urgent actions to alleviate the consequences to our health system.1,2
- Securing the Supply Chain: EFCG and BPTF members play a fundamental role in the pharmaceutical supply chain and aim to secure the supply chain through pragmatic mitigating actions. They are actively working with the European Union, U.S. authorities, and other relevant industry stakeholders to solve this urgent problem promptly.1
- Encouraging Precautionary Actions: EFCG and BPTF encourage authorities to take precautionary actions, such as setting up fast-track approvals for alternate Registered Starting Materials (RSMs) and APIs and actively reinforcing the pharmaceutical supply chain in the West, guaranteeing its competitiveness, and supporting the industrialization of innovative processes.2
- Proposing Solutions: The EFCG detailed the complex causes and possible solutions to this problem in its recent position paper.2 They believe that the availability of vital medicines is every patient’s fundamental right and that current and future critical shortages impact this right.
These efforts by the EFCG are crucial in addressing the current drug and API shortages and ensuring the continuity of essential medicines for patients.
SK pharmteco is now a member of both the EFCG and Cefic. By engaging with EFCG, we reinforce our commitment to advancing industry standards and supporting our customers in their mission to deliver life-impacting medicines. Our involvement ensures that we remain at the forefront of regulatory developments, enhance market access, and contribute to the global competitiveness of European chemical innovations in the small molecule GMP analytical development and GMP manufacturing space. This strategic engagement aligns with our broader goal of enabling our customers to achieve breakthrough solutions and deliver essential therapies that make a significant impact on d.
As a trusted global CDMO, SK pharmteco produces high-quality APIs and is a reliable partner to assure supply chain security and continuity. Contact us to discover how we can support your next project.
