Proposed European Union Pharmaceuticals Legislative Changes

The EU (European Union) has published proposed changes to pharmaceutical legislation, which will undergo review by the European Parliament and the EU Council before ratification and implementation. Discussions between the EU Commission, the MS (Member State) and all stakeholders are ongoing. The Commission adoption feedback period has been extended to 24 September 2023.

Developing products is a lengthy process. The cost of developing new and modified products is increasing, so it is important to be aware of procedures and timelines for obtaining marketing authorisations and importantly to know what if any post approval data and marketing protection is available.

Strategy involves long term planning and companies need to know what if any of the proposed changes will impact on their current planning and approach.

The proposed changes are intended to address the main shortcomings in the current system which were identified as follows: 

·       Medical needs of patients are not sufficiently met

·       Affordability of medicinal products is a challenge for health systems

·       Patients have unequal access to medicinal products across the EU

·       Shortages of medicinal products are an increasing problem in the EU

·       The medicinal product lifecycle can have negative impacts on the environment.

·       The regulatory system does not sufficiently cater for innovation and in some instances creates an unnecessary administrative burden 


There will be two new legislative documents:

A new Directive: repealing and replacing Directive 2001/83/EC and Directive 2009/35/EC and incorporating relevant parts of the Paediatric Regulation 1901/2006.

A new Regulation: repealing and replacing Regulation No 726/2004 and Regulation No 141/2000 on orphan products and repealing and incorporating relevant parts of the Paediatric Regulation No 1901/2006.

There are also proposed changes to the operation and responsibilities of the European Medicines Agency (EMA).

Main Stated Objectives

  • Innovation
  • Access
  • Affordability
  • Environmental Protection

Who benefits?

The patients

This will bring a patient centred-approach, with timely and equitable access to innovative new products and affordable medicines. What's more, there will be enhanced security of supply, and it will address shortages through specific measures.

In addition, there will be compulsory licencing by Comptent Authorities (CAs) to tackle public health issues in an emergency. 


This depends on the company. 

For Innovative companies, variable protection for orphan products and a generally reduced market protection period to eight years with incentives if launched in all MS, address Unmet Medical Need (UMN), consider multiple indications in development, conduct comparative CTs (Clinical Trials) or repurpose products and for developing new antibiotics.

Theoretically there is a maximum of 12 years market protection under certain conditions which may be difficult to satisfy: e.g. HUMN (High Unmet Medical Need) with paediatric use, available in all MS and launch within 2 years of approval.

Generic companies would benefit from earlier access to market for generics and biosimilars


  • Responsibilities expanded
  • Committees reduced to CHMP (Committee for Medicinal Products for Human Use), CVMP (Committee for Medicinal Products for Veterinary Use) and PRAC (Pharmacovigilance Risk Assessment Committee)
    • All other committees will operate through working parties
  • Criteria for mandatory CP (Centralised Procedure) extended
  • Timelines for assessment and Commission decision periods reduced

For more information and discussion and learn more about the proposed legislation by registering for the IPI webinars: ‘EU Pharmaceutical Regulation and Strategy’ and/or ‘Regulatory Affairs for Support Staff



Comments and opinions are personal

This blog will be updated as opinion changes and the ratification and implementation status of the proposed legislation becomes clearer.

Norah Lightowler


Published on Sep 12, 2023 by Gareth Cartman