The first of November 2017 has become a notable and unprecedented date in the history of medicines regulation. This is the first day of coming into force of a Mutual Recognition Agreement (MRA) of Good Manufacturing Practice (GMP) inspections of manufacturers of medicines for human use between the FDA and the EU. This initial stage will involve 8 EU member states including the UK with other EU states added as their evaluations are completed by the US with the intention to assess and recognise all agencies by the 15th July 2019. Never before has the FDA recognised another countries inspectorate and this is a remarkable step recognising the global enterprise that the pharmaceutical manufacturing industry has become. It is notable, according to the EU, that around 40% of finished medicines within the EU come from overseas and 80% of the manufacturers of active pharmaceutical ingredients for medicines available in the EU are located outside the Union.
In order to make this MRA a reality the EU and US have built up assurance that each GMP inspectorate have the ability to supervise manufacturing activities at an equivalent level. Since 2014, this has involved teams from the national authorities auditing and assessing each other’s systems and observation of each inspectorate as part of a joint audit programme which has culminated in the agreement which has now become operational.
According to the FDA and EU in press releases posted on the 31st October 2017, this marks a key milestone in a process which started in 1998 and was intended to strengthen reliance between the FDA and EU inspectorates expertise and resources. The ability and willingness to share information and utilise each other’s inspection outcomes and data is an example of the trust that has grown up between the US regulator and the EU over many years. The anticipated benefits include;
- The sharing of information especially with respect to medicines defects
- Focus resources beyond the EU / US where API and medicines manufacturing for the EU and US markets takes place.
- The ability to prioritise manufacturing sites on higher risk cases
- Increase the ability to identify and resolve problems before they become a risk to public health.
- Reducing administrative burdens and costs facing manufacturers both big and small. The reduction of duplication will be key here.
One immediate benefit to a contract testing laboratory will be the removal of duplication as GMP inspections are currently carried out by the FDA and the UK regulator. It will be a welcome reduction of resource required to host and manage these GMP inspections if only one is required.
One caveat is of course Brexit as this agreement is at the EU level and it is to be hoped that the benefits gained will be incorporated into any MRA agreed between the UK and the EU. It also should be noted that other non EU inspectorates are beginning to conduct inspections within the UK.
Press Releases EU & FDA
MHRA Inspectorate Blog Post 1st Nov 2017, EU-FDA Mutual Recognition of Inspections of Medicines Manufacturers Enters Operational Phase