Mutual Recognition Agreements On Gmp Inspections

The first work on the content of the IMM began in 2014, when teams from the European Commission and relevant EU, EMA and FDA authorities began to review and evaluate the respective surveillance systems. In June 2017, the European Commission was the first to recognise the FDA`s ability and procedures to conduct GMP inspections at a level equivalent to that of the European Union. In November 2017, the FDA recognized for the first time the capacity of a first group of eight European countries (Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom). In 1996, another mutual recognition agreement between the EU and the United States was signed, which contained a pharmaceutical annex, but which was never fully implemented. This annex formed the basis for the new 2017 agreement, as well as the results of several pilot GMP inspection initiatives. The FDA`s recognition of Slovakia as the last European country to be admitted under the US-EU Mutual Recognition Agreement (MRA) took place on 11 July 2019; The agreement was signed a year earlier, in July 2018, by US President Trump and Jean-Claude Juncker as representatives of the European Commission. MRAs now apply only to drugs for human use, but authorities on both continents will continue to work to extend them to veterinary drugs, dener vaccines, humans and plasma-based drugs. « The MRA means that drug authorities on both sides of the Atlantic can now rely on the results of inspections to replace their own inspections. Today, the U.S. Food and Drug Administration has completed the capacity assessments of the 28 relevant European authorities, the result of a five-year close transatlantic cooperation, » said Vytenis Andriukaitis, European Commissioner for Health and Food Safety. Think about the days you learned that FDA inspectors were going to inspect your facility.

Shortly after the FDA inspection, inspectors from the European Medicines Agency (EMA) arrived again for an inspection. Signed with the MRA, it`s a sigh of relief for drug manufacturers. Many production sites on both sides see fewer inspections. As soon as companies see dual inspections of the FDA and EMA and GMP. Under the MRA, EU and US regulators will accept the inspections of each other in order to prevent the work from being repeated – Slovakia – only for inspections of chemically synthesized pharmaceutical active substances for use in human oral drugs and manufactured in a special facility for a single product. « Together, Europe and the United States account for more than 80% of global sales of new medicines. » (European Commission). Because inspections comply with strict EU and US standards, there is an influence on the distribution of products sold in the two largest markets. Since websites fall under the jurisdiction of both markets, companies will face strict enforcement measures if they are found to be non-compliant. The Mutual Recognition Agreement (MRA) between the FDA and the European Union allows drug inspectors to rely on information from anti-drug inspections carried out within the other country`s borders.

Under the Drug Safety and Safety Act passed in 2012, the FDA has the authority to enter into agreements on the recognition of drug inspections by foreign regulators when the FDA has found that these authorities are able to conduct inspections in accordance with U.S. requirements. The FDA and the EU have been cooperating since May 2014 to assess how they control drug manufacturers and assess the risk and benefits of mutual recognition of inspections.