2. Medicines regulation and collaboration at the global level
Medicines regulation and collaboration at the global level
In the EU, medicines regulations are harmonised and implemented across all 27 member states. Furthermore, the regulations also cover the European Economic Area (EEA), i.e., the EU plus Norway, Iceland and Liechtenstein. For the rest of the world, the regulation of medicines is determined by a country’s National Competent Authority (NCA).
At a time when modern medicines manufacture and distribution are increasingly globalised, cooperation between medicine regulators has become essential, and multiple models of regulatory collaboration are being implemented in all regions of the world. The challenges faced by regulators in an increasingly complex regulatory environment are shared and recognized by the EU as well as the need for harmonisation of rules, procedures and practices.
Such harmonisation is in the interest of patients, regulatory authorities and industry. The aim of harmonising requirements is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
The EU collaborates with other parts of the world. Harmonised guidelines are prepared together with the USA and Japan. Many other regions and countries are now included within this collaboration (International Council for Harmonisation, ICH, see below).
The major stakeholders at the global level have traditionally been:
- EU: EU Commission, EMA and the Heads of Medicines Agencies (HMA) network
- World Health Organisation (WHO)
- USA: Food and Drug Administration (FDA)
- Japan: Ministry of Health Labour and Welfare (MHLW)
More recently, China has become closer associated to the ICH processes by developing their regulatory approaches.