Us And Eu Fully Implement Mutual Agreement On Gmp Inspections

Each year, EU national authorities and the FDA inspect many drug production sites in the EU, the US and elsewhere in the world to ensure that these sites operate in accordance with good manufacturing practices (GMPs). Under the MRA, EU and US regulators will now rely on inspections of medicines for human use on their own territory, thus avoiding duplication. As a result of the MRA, both the EU and the US will be able to free up resources for inspection of facilities in other countries. Under the MRA, EU and US regulators will now accept inspections of others to prevent the work from happening again. In 1998, the EU and the United States signed a large-scale MRA containing a pharmaceutical annex that provides for an expected and limited reliance on GMP inspections of the other party. However, this agreement has never been fully implemented. The EU and U.S.-compliant companies will have faster access to common markets and other countries dependent on FDA and EMA inspections. Europe and the United States account for more than 80% of global sales of new medicines. However, a large proportion of APIs and finished medicines are imported from countries outside their territory. The agreement allowed both the fda and the EMA to increase inspections in countries with a higher risk of non-compliance. The updated MRA between the EU and the US has practically become a separate sectoral agreement, while the TTIP itself is on hiatus. The initial agreement was concluded in 1998 as part of a mutual recognition agreement between the EU and the United States, which also included telecommunications and electrical equipment (5).

But the part of the drugs, which was already limited, was never fully implemented. One of the main questions posed by both parties was the extent to which the confidentiality of commercial information should be protected and, in particular, from the perspective of the US Food and Drug Administration (FDA), the recognition of the competence of all EU national regulatory authorities. This situation became a critical issue following the accession of 10 new Member States, mostly former communist countries in Eastern Europe under the leadership of Poland, Hungary, the Czech Republic and Slovakia, in 2004. Manufacturing companies outside the EU and the US are experiencing an increase in post-IMM inspections from the US and EU. This is because the EU and the US import a large proportion of IPIs and finished medicines from countries outside the United States. The agreement allows agencies on both sides to allocate their inspection resources to agencies that supply these APIs and finished drugs. This will allow appropriate controls to be applied in the event of enhanced inspections to improve product quality and safety. The agreement does not currently apply to veterinary medicines, but the EU and FDA have agreed that veterinary drugs will be included by 15 December 2019 and discussions have already taken place between technical experts. Over the past seven years, the EMA and the FDA have collaborated on GMP inspection activities to build trust.

In addition to monitoring the audit of the EMA by national authorities, a joint pilot GMP inspection programme has been put in place, the allocation of tasks during inspections and regular meetings on the plans and results of inspections. The text of the agreement stipulates that the FDA must have assessed the authorities of eight EU countries by November 2017 in order to trigger the start of the implementation of the IMM (3). The FDA`s assessment of the other 20 national authorities is scheduled for completion by July 15, 2019 (3). The EU clarified that the MRA covers all EU member states, so that if the FDA has not completed its assessment of all EU national agencies by the 2019 deadline, the agreement will be terminated (3). The agreement between the European Union and the United States on mutual recognition of GMP inspections (1), announced at the beginning of March 2017 (1), was a major step forward in the EU`s desire to play a key role in achieving unife standards

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