Pharmaceutical regulation aims to ensure the safety, quality and efficacy of pharmaceutical products intended to improve the health and welfare of patients.
Practically it means working on a wide range of subjects such as, the preparation of documentation for an application for a marketing authorisation in the EU; providing evidence that medicines are made in compliance with existing regulations (Good Manufacturing Practice/GMP); ensuring the continuous monitoring of medicines once they have entered the market, in order detect potential safety and quality issues; and relaying information - including real world evidence - that might require a revision or update to the marketing authorisation details.
Regulatory affairs also deals with global regulatory collaboration and convergence, with regulators across the world facing a number of common challenges including greater interdependence, a rising workload and limited resources. The onus is growing on regulators to work together to achieve a more integrated approach to regulation.
Global regulatory convergence is a means of aligning regulatory requirements across the world via a process of gradual uptake of internationally accepted/recognised technical and procedural standards and principles, with the aim of improving healthcare. It does not necessarily mean that all laws and requirements are harmonised, but that greater regulatory co-operation may be achieved. Such approaches cut regulatory red tape and allow for faster access by patients to quality and safe medicines all around the globe.
Regulatory Affairs at EFPIA
The EFPIA Scientific, Regulatory & Manufacturing team is in charge of EFPIA’s work with ICH and is the main contact point for the European Medicines Agency and the Heads of Medicines Agencies (HMA), as well as other global regulatory bodies. The team works across a range of issues such as:
- Support Innovative regulatory approaches
- Novel regulatory pathways (e.g., Pharmacovigilance (PhV), Clinical Trials (CT), IT implications and of adaptive pathways)
- Use of real world evidence and Big Data to make regulatory decisions
- Increased data transparency through development of industry codes and standards (CT, post-marketing data)
- Implications of stakeholder involvement in regulatory processes
- Joint / parallel scientific advice (SA)
- Regulator / HTA intersection and sharing of information
- Patient involvement and engagement (e.g., in CT planning, SA, labelling information)
- Regulatory technology infrastructure
- Implementation of patient registries (implications for Pharmacovigilance (PhV), CTs, Adaptive Pathways, etc.)
- Implementation of new IT systems (e.g., IDMP standard, CT transparency database)
- Effectiveness of the EU Regulatory network
- Engagement on EMA/HMA Strategy 2020 & HMA Strategy 2020
- Regulatory implications of relative efficacy / effectiveness considerations
- Implementation and streamlining the key legislations; CTs and PhV
- Environmental sustainability
- Pharmaceuticals in the Environment (PIE) and industry strategy to address the emerging issue
- Trust and reputation building through transparent management of environmental sustainability
- Global regulatory collaboration and convergence includes:
- Regulatory convergence topics such as ICH, EMA and FDA coordination of GMP inspections.