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. The agreement, initially announced in 2017, represents a three-year cooperation between the FDA and the EU and will allow all partners to recognise inspections carried out by each other. One of the benefits of the EU-US Mutual Recognition Agreement (MRA) is fear. Fear. Sleepless nights. Terror of disrespect. Do you remember the thoughts that crossed your mind when you heard that a regulator was going to inspect your facility? Then multiply that by 10, when you learned that not only are the members of the US FDA coming to inspect your facility, but that inspectors from one of the Member States of the European Medicines Agency (EMA) arrive for an inspection only a week after the fda ends. Breathe deeply, life is getting better! Finally, the implementation of a historic agreement between the FDA and the EMA means that these days are behind you. Differences of opinion on the effectiveness of the proposed new treatments were the main causes of divergence in final licensing decisions on both sides of the Atlantic. Some differences were also observed in the evaluation of clinical data, often due to the difference in the date of their submission: in general, applications were submitted to the FDA at trial and subsequent use at the EMA may include data from additional clinical trials or, particularly for oncology drugs, more mature data from the same clinical trial.
As a result, it was found that the EMA was more likely to issue a standard authorization, a broader indication or the use of a drug as a first-line treatment. “The strong convergence in the marketing authorization of new drugs by the EMA and the FDA is the result of increased investment in dialogue and cooperation since 2003 and has fostered harmonisation between the EU and the US with respect to marketing authorisation decisions, while both agencies assess applications independently” said Zaide Frias, head of the EMA division for the evaluation of medicines for human use. “Our cooperation clearly helps the two agencies achieve a common goal of maximizing patients` access to safe, effective and quality medicines in both regions,” she added. So while the arrival of an inspector is always stressful, you can be sure that only one agency will probably appear on your doorstep for a GMP inspection. In addition, the MRA facilitates the importation into the EU of commercial and test drugs from the United States, removing the requirement to verify information relating to the manufacture of medicines, including batch registration, testing and GMP compliance verification by a PQ. Access to clinical trials in European Member States is now more streamlined than ever. If you intend to use MRA and conduct clinical trials across the European Union, Pearl Pathways specialist advisors can support the submission of control files to your company`s EMA Member States. Contact us today for a free consultation. 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.