Fifth strategic field of the of the EMA’s network strategy

This area probably shows the complexity of today's global care structures in the 21st century most clearly. Due to global networking, medicinal products are often produced in distant countries (mostly India or China), imported to Europe, possibly relabeled, and finally distributed locally. In this context, the EMA sees the need to increase its review capacities and thus gain more insight into the supply chains. To this end, the highest European medicines authority, together with the HMAs, formulates the following goals:

1. Improve traceability, oversight, and safety along the medical supply chain across production, import and administration of active substances or excipients.

2. Promote the development of inspector capacity at EU and international level to address the issues of active substances, new technologies and continuous manufacturing.

3. Strengthen accountability for product quality through harmonization and reinforcement of guidance to facilitate a coherent approach by regulators and industry to standards for human and veterinary medicines.

4. Promote supply chain resilience and review the long-term risks of relying on a limited number of manufacturers and sites to ensure continuity of supply and availability of medicines.

5. Analyze the potential implications of new production technologies and adapt the existing regulatory framework to take advantage of these innovations in the manufacturing and distribution process of human and veterinary medicines.

The importance of supply chains, and particularly their failure, was highlighted by the COVID-19 pandemic. In addition to the solutions already proposed above, the implementation of a risk assessment at launch is also being discussed, which should present potential risks and provide an overview of which active ingredients or excipients are sourced from which part of the world. Another political step that is already addressed in the strategy is the possibility of promoting the production of medicinal products in the EU in the future.

The emerging trend of Pharma 4.0, based on the developments in Industry 4.0, is also linked to the issues surrounding supply chains. Within the framework of this concept, new technologies such as sensor technology are used to further digitalize industrial production and realize efficiency gains. In this area of activity, overarching regulations can help to implement the new technologies quickly and thus equip pharmacies or hospitals with their own production units for medicines based on 3D printing technology. This development towards continuous manufacturing (CM) is a core element of the new strategy pushed by the EU policy and clearly indicates the development away from the batch-based production system.

Taken together, these considerations regarding the drug distribution process are highly relevant and will add further weight to the developments in marketing authorization. At SKC, we are tracing developments closely and are already implementing these new impulses into market access strategies for our clients.