On 13th October 2016, the European Medicines Agency (EMA) has published a comprehensive overview of existing international regulatory initiatives for human medicines. The mapping was carried out by EMA on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA was launch in 2013is a strategic coordinating, advocacy and leadership group of regulatory authorities that seeks to address current and emerging human medicine global regulatory and safety challenges, provide direction to regulatory authorities, and identify areas of commonality and potential synergies.
The report lists all international projects and provides international regulatory agencies with comprehensive details on the number and scope of global initiatives that can support decision-making on future projects, prioritisation and coordination.
The aim of the exercise is to raise awareness of ongoing international regulatory activities, establish a basis for a more strategic coordination to avoid duplication of efforts, and identify possible gaps.
The report includes not only broad ranging activities such as the harmonisation work of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), but also identifies areas of particular strategic interests for ICMRA. These include:
• Generic medicines
• Good Manufacturing Practice inspections
• Exchange of confidential information
• Supply-chain integrity
• Crisis management
• Information technology systems.
Specific mappings in these areas will be published by EMA in early November 2016.
The new report was presented at a summit of heads of medicines regulators and the annual ICMRA meeting that took place in Switzerland in October 2016.