COVID-19 Access Industrial Policy Regulatory and legal framework Falsified medicines Environment Antimicrobial resistance Medicine shortages


Regulatory and legal framework

In Europe the pharmaceutical legislation and existing guidelines regulate the entire lifecycle of medicines, from their development over their approval and entry on the market to their availability for the patient. Both Generic Medicines and Biosimilar medicines are important parts of the EU pharmaceutical legislation. Medicines for Europe and its member companies and associations support and promote a European regulatory framework that ensures patient access to high quality, safe and effective medicines and that focusses on the highest-priority issues that make the real difference for patients.

During the development of generic, biosimilar or value added medicines, clinical trials have to be performed to establish an equivalence with the originator product. Medicines for Europe and its members support a strong EU Good Clinical Practices (GCP) system as a cornerstone for ensuring the quality of the clinical data supporting marketing authorisations of all medicines. In view of the globalisation of the industry and to avoid of unethical repetition of studies for the purpose of marketing authorisations in several regions, Medicines for Europe calls for a high-standard global regulatory convergence in the field of clinical trials, enabling the single global development of generic, value added or biosimilar medicines.

Before a medicinal product is allowed access to the market it needs to be registered and obtain a marketing authorisation which needs to be updated by variations throughout the lifecycle of the product. In the light of the importance of an efficient regulatory system in providing greater and timely access to high quality medicines for patients across Europe, Medicines for Europe has published the Regulatory Efficiency Report which proposed several solutions to remove unnecessary duplications, reduce administrative burdens and promote the effective use of IT systems to support regulatory processes. Special emphasis is placed on the optimisation of the variation system, which is particularly burdensome for authorities and industry.

Once the product is on the market, the quality, safety and efficacy needs to be assured. In this regard, Medicines for Europe encourages the production of pharmaceutical ingredients and medicinal products to the highest standards of excellence. All the individual companies represented by Medicines for Europe abide by the rules of Good Manufacturing Practice (GMP) in approved and regularly inspected production plants. Moreover they are committed to maintaining a stringent overview of their suppliers and outsourced activities and to set up resilient supply chains to guarantee a sustained access to medicines for patients.


In the context of the on-going discussion on Nitrosamines, Dr George Johnson has developed a study entitled “Review of Nitrosamine Drug-Substance Related Impurities (NDSRI)  in Pharmaceutical Drugs: Risk Assessments, Acceptable Intakes, and QSAR Tools”.

The study addresses the following topics:

  • Exemplar nitrosamine compounds to test relative potency between in vivo mutation and cancer.
  • Investigate whether NDSRIs have low or no potency and could be considered as a non-cohort of concern (non-CoC).
  • Investigate using in vivo mutation BMD CI for relative potency assessment to further inform on potency categorisation (EMA #1-5).
  • Comparisons with levels in food.
  • Consider the AI from EMA, US FDA and Health Canada, calculated using the CPCA approach.

Medicines for Europe trusts that this study can provide more publicly available information to stakeholders about the different facets of the regulatory review and that it contributes to the implementation of the recent nitrosamines guidelines, in line with the best scientific understanding of the challenges.

To access the study, please click on the following link: Review of Nitrosamine drug substance related impurities in Pharmaceuticals drugs (10/2023)


All the members of Medicines for Europe have a pharmacovigilance system in place to monitor the safety of their products on the market.