Tga Mutual Recognition Agreement

April 12, 2021

The table below contains the countries and regulatory authorities with which we currently have a Mutual Recognition Agreement (MRA) or an equivalent agreement/arrangement. The registration process for BMP for manufacturers controlled by these regulators depends on the fact that the inspection was carried out within or outside their borders: Australia and the United Kingdom (United Kingdom) have signed an MRA on compliance assessment, certificates and markings in anticipation of the UK`s exit from the European Union. This MRA also includes recognition of the medical device compliance assessment certification. Australia has a Mutual Recognition Agreement (MRA) with the European Community (EC) and the European Free Trade Association (EFTA), which includes Iceland, Liechtenstein and Norway. The MRA includes compliance assessments for veterinary products. The TGA has concluded several international agreements and agreements with other countries and regulatory authorities to support international regulatory cooperation. Some of these agreements and agreements allow us to use the inspections carried out by these regulators as part of the GMP release procedure instead of our own on-site inspection. In some cases, we may also recognize audit reports and final instructions from the relevant authorities who are members of the Inspection/Cooperation Agreement (external link) (PIC/S). This recognition is done on a case-by-case basis.

Since different legal and regulatory requirements apply between MRA partners, the MRA does not create a direct equivalence between Australian and EU legislation. On the contrary, the MRA allows mutual recognition of test results and other compliance assessment documents, including certifications. 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.

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