What’s next in the regulatory landscape for generic medicines?

Join us for the 2026 Regulatory & Scientific Affairs Conference on 26-27 February in Amsterdam; stay informed and your share your views!  Our 2026 Conference comes at a pivotal moment – after the pharmaceutical legislation outcome is decided. The industry and regulators face years of implementation and adaptation. The Conference will address preparing for upcoming changes, plus digitalisation, new responsibilities, and environmental requirements.

Key stakeholders, including leading regulators, industry experts, and European institution officials, will come together to engage in discussions and debate on the regulatory challenges and opportunities that lie ahead.

Looking to the future – What changes can we expect in the pharmaceutical environment in the years ahead?  

• Update on the Revision of the Pharmaceutical Legislation-where are we headed?
• Critical Medicines Act and Biotech Act as tools to increase EU competitiveness and security of supply
• Horizontal legislation and pharmaceutical specific legislation – how to achieve a coherent policy and address the impact on access to medicines?
• Implementation of the EMA & HMA Strategy 2028

How to transition smoothly to modern methods of patient access to medicinal product information. 

Watch this space!  Changes in pharmaceutical legislation significantly affect operational activities of companies

• The future implementation of the ASMF certification process and its co-existence with the EDQM’s CEP
• Stronger quality, steady supply: navigating new regulatory requirements for sustainable access
• Greater influence of competent authorities on the market and business decisions because of new legal provisions

Handling the life cycle management of medicinal products in the future

• The Implementation of the revised Variations Regulation and Variations Classification Guideline
• Opportunity to digitalise variation reporting via a database

The next five years in Regulatory Affairs

• How to prepare for new challenges and translate them into internal business processes
• CMDh and EMA work plans until 2028- what future opportunities are there for the off-patent sector?

Three webinars

• Horizontal environmental legislation and the impact on pharmaceutical products
• Say goodbye to the Art 57 database- the decommissioning of XEVMPD, PMS data enrichment and validation, the PMS API, and its effects on ESMP and ePI.
• Pharmacovigilance – Signal detection and safety label changes

For more details, visit: www.medicinesforeurope.com/RAC26