All countries where medicines are licenced for use have a regulatory system. From the point of view of a potential MAH (pharmaceutical company) seeking worldwide marketing rights, the regulatory bodies its programmes must satisfy include the Food and Drug Administration (FDA) of the USA, the European Medicines Evaluation Agency (EMEA) of the European Union (EU), and the Japanese Pharmaceutical Affairs Bureau. The national regulatory bodies of the individual EU members remain in place and work with the EMEA (see below). National licences can still be granted through individual member states, and they maintain particular responsibility for the public health issues in their own country. Some appreciation of the system in Europe is important. Up until 1995, applications for licences had to be made to these separate national authorities. This was enormously wasteful in time and manpower, as drug developers had to adapt their research and clinical development programmes to meet diverse national (often bureaucratic) requirements. In addition to the introduction of the European system, significant harmonisation of practices and procedures at a global level (especially Europe, Japan and the USA), have also been achieved through the International Conferences on Harmonisation (see p. 53, footnote 4).
In the European Union, drugs may be licensed in three ways:
• The centralised procedure allows applications to be made directly to the EMEA, which are then allocated for assessment to one member state (the rapporteur) assisted by a second member state (co-rapporteur). This approach is mandatory for biotechnology products and optional for new medicinal products.
• The mutual recognition (or decentralised) procedure allows applicants to nominate one member state (known as a reference member state), which assesses the application and seeks opinion from the other (concerned) member states. Granting the licence will ensure simultaneous mutual recognition in these other states, provided agreement is reached among them. There is an arbitration procedure to resolve disputes. • A product to be marketed in a single country can have its licence applied for through the national route.
The European systems are conducted according to strict timelines and written procedures and there are regulations in place to handle disagreements between member states and rights of appeal for applications against refusals to licence.
Once a medicine is licenced for sale by one of the above procedures, its future regulatory life remains within that procedure. Licences have to be reviewed every 6 months for the first 2 years, then annually until 5 years, then renewed subsequently at 5-year intervals. The renewal of a licence is primarily the responsibility of the MAH but requires approval from the regulatory authority. This is the opportunity for MAHs to review, especially, the safety aspects to keep the licence in line with current clinical practice. Any major changes to licences must be made by variation of the original licence (safety, efficacy or quality, see below) and supported by data, which for a major indication, can be substantial.
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