The legislative reforms, and specifically the changes relating to environmental risk assessments (ERAs) for pharmaceutical companies under the EU's pharmaceutical regulatory framework, are having significant impacts. But which companies are being impacted most and how?
Manufacturers of Generic Drugs
Companies that produce generic versions of branded pharmaceuticals are on the frontline. Typically operating on thinner margins and with the additional costs of the comprehensive ERAs required to meet the updated environmental safety standards, will likely result in reduced profitability. Since generics form a crucial part of affordable healthcare, aligning with the new requirements efficiently is essential.
Innovator Companies
The testing strategy and requirements have been modified in the new ERA guidelines, leading to an increase in the requirement for physical/chemical testing and a potential increase in the number of active substances triggering an assessment in the soil compartment. Companies in the process of developing new active substances should be aware of these updates to ensure their ERA is sufficient to meet the current requirements.
Marketing Authorisation Holders
Companies holding an existing marketing authorisation and wishing to submit applications for type II variations or extensions may need to submit an ERA if there is an anticipated increase in environmental exposure. If the original marketing authorisation application (MAA) was submitted before 2006 no ERA will be available and the company will be required to perform one. If a previous ERA was submitted with the original MAA the changes to the ERA guidelines and testing requirements may mean the previous ERA is insufficient and additional work is required to prepare a compliant ERA.
High-Volume Pharmaceuticals
Pharmaceuticals that are produced and prescribed in large quantities will likely see the greatest environmental impact – attracting strictest scrutiny under the new regulations. Companies involved in manufacturing widely used generic medications, such as antibiotics and pain relievers, will need to pay particular attention to how these drugs and their residues affect ecosystems – especially aquatic environments.
Development of High-Risk Substances
Pharmaceutical manufacturers dealing with substances classified as having high environmental risk – those persistent in the environment, bioaccumulative, toxic, or those that contribute to antimicrobial resistance – will face more stringent assessment and mitigation requirements.
Global Pharmaceutical Companies
Multinational companies that distribute their products across multiple regulatory jurisdictions will need to ensure that their ERAs meet the standards of the European Union, possibly leading to a need for additional assessments or different strategic approaches compared to other regions.
Each of these types of companies need to strategically approach the legislative changes, to ensure their pharmaceutical regulatory compliance – maintaining operational efficiency and market competitiveness. This will likely involve investments in new technologies and methodologies, partnerships for data sharing, and possibly re-evaluation of supply chains to mitigate environmental risks effectively.
If your company falls into any (or many) of the categories above, or if you’re trying to overcome your own specific challenges relating to EU pharmaceutical regulatory compliance, our team of experts are ready to help. We’re specialists in regulatory compliance, including environmental risk assessments, consortium management and advocacy. Call and speak directly with one of our pharmaceutical regulatory compliance experts.
