“We welcome the implementation of this agreement, which means that authorities on both sides of the Atlantic can now count on the results of each other`s inspections. This step is proof of the importance of our strategic partnership with the United States. It will make the most of our inspection capabilities so that patients can count on the quality, safety and effectiveness of all medicines, regardless of where they were manufactured,” said Guido Rasi, Executive Director of the EMA. During a transitional period, the authorities assess each other`s pharmaceutical legislation, guidelines and regulatory systems under the agreement. These agreements benefit regulators by reducing dual controls in any other area, allowing for a greater focus on sites likely to be at higher risk and increased coverage of global supply chain inspections. Restrictions: Capacity determination applies to routine inspections. In the future, the following types of products and inspections may be included in the scope of the agreement until further reflections are carried out: the US Food and Drug Administration (FDA) and the EU European Medicines Agency (EMA) have announced Slovakia`s addition of a Mutual Recognition Agreement (MRA) for inspections of good manufacturing practices (BPF) in the European Union. Slovakia was the last of the 28 EU Member States to be recognized as capable of carrying out inspections of production facilities that met FDA requirements. The MRA allows the FDA and EMA to use inspection reports and other related information obtained by the other authority during inspections of production facilities. Each agency may require additional inspections or other measures when necessary to protect the public. The recognition of European drug supervisory authorities as capable of conducting fda-compliant inspections is part of the implementation of the modified pharmaceutical schedule in the U.S. – EU.U. MRA of 1998.
The current scope of the agreement covers only medicines for human use, with the exception of vaccines and plasma products. Among the products covered by the agreement, it should be noted that the prevention of double measures during the inspection of a particular pharmaceutical production site will reinvest the financial resources needed to increase the number of controlled sites in other major producing countries. During the first phase of implementation, the agreement applies only to inspections carried out in the affected areas and not in EU or third country subscribers (although this possibility is provided for in Article 3.1 of the GPF sector annex to the MRA). But this provision, EMA warns in a recently published Q-A document, is not yet active and further guidelines will be published in the future to direct this type of activity. As of 1 November 2017, European NCAs will not duplicate inspections already carried out by the FDA and the US authority is not expected to carry out double inspections by a recognised EU authority. Exceptionally, EU agencies and the FDA reserve the right to inspect each other at any time in each other`s territory. The European Union (EU) has signed Mutual Recognition Agreements (MRA) with third-country authorities on the assessment of compliance of regulated products. These agreements contain a sectoral annex on mutual recognition of good manufacturing practice inspections (GMPs) and certification of batches of medicines for human and veterinary use. The transition period for human-use medicines under the agreement ended on 11 July 2019: the FDA`s recognition of Slovakia as the last European country to be authorised under the US-European Union (MRA) Mutual Recognition Agreement 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 only apply to medicines for human use, but authorities on both continents are
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