Better Regulation

The regulatory framework in which businesses operate is a key factor in their competitiveness, growth and employment performance. Therefore, a key objective of the European Union's Enterprise policy is to ensure that the regulatory environment is simple and of high quality. This is why "better regulation" is a centrepiece of the European Commission's "Partnership for Growth and Jobs" - the renewed 'Lisbon Strategy' launched in spring 2005.

General Information 

Major developments

Medicinal products for human use

Medicinal products for veterinary use

General Information 

To make sure that regulations are used only when necessary and that the burdens they impose are proportionate to their aim, the Commission has a number of processes and tools in place:

  • Withdrawal or modification of pending legislative proposals
  • Measures to simplify existing legislation
  • Better quality of new Commission proposals: systematic use of  impact assessment and public consultation in the development of new policy proposals
  • Monitoring and reducing administrative burdens thanks to CUT 25% on-line questionnaire

For more detailed information see the Secretariat General's website on Better Regulation.

Better regulation and the pharmaceutical sector

In the context of the renewed Lisbon Strategy, refocused on growth and jobs, the Commission has taken a clear and strong position in favour of better regulation and committed itself to reinforced efforts to deliver concrete benefits for businesses and competitiveness.

Despite major progress, however, there is still room to improve the smooth functioning of the EU internal market for pharmaceuticals. On the regulatory side, issues with the implementation and interpretation of Community legislation by Member States continue to create obstacles to the free movement of medicines and fragment the EU market.

In order to optimise, simplify and rationalise the regulatory processes and also achieve real benefits for European consumers, patients and animal health in a rapidly changing world of scientific advances in medicine, the Commission has adopted concrete measures aiming at reviewing and simplifying EU pharmaceutical legislation.

Better Regulation - Major developments