The revised MRA covers the vast majority of pharmaceutical products, including investigational drugs; marketed prepared medicinal products (including medical gases, radiopharmaceuticals, herbal products regulated as medicinal products and homeopathic products); certain biologics placed on the market (including products derived from therapeutic biotechnology and allergenic products); in-process materials and intermediate products; and active pharmaceutical substances or bulk-drugs. Veterinary medicinal products, vaccines and plasma-derived products do not immediately fall within the scope of the agreement, but the document calls for these products to be included at a later date. Therefore, the impact of MRA on a given company may depend in part on the location of its facilities. Production sites in the US and the 28 EU Member States are likely to be subject to fewer double inspections, reducing the costs of preparing for inspections, both by the FDA and by an EU inspection. The agreement could also speed up the results of inspections and speed up the introduction of authorised products in several legal systems. Mutual Recognition Agreements/Understandings (AMAs) are possible trade measures between governments aimed at adopting a comprehensive approach to conformity assessment. (These agreements should not be confused with mutual recognition agreements between accreditation bodies) Government agreements can be cross-sectoral agreements, as in the context of the IRM between the US and the EU, and cover more than one product category. Agreements can also be multilateral, as in APEC Tel MRA, and provide a framework for all member states (countries) that can follow them. In each of the agreements, the participating countries undertake to accept the results of tests and/or product authorisations carried out by the conformity assessment bodies (CSFs) of the other country.
While the framework of the agreement is firmly anchored, some important milestones need to be reached before it is fully implemented. In particular, before relying on the results of the inspection, the agreement calls on the FDA and the EU to carry out preliminary checks by the supervisory authorities of the other and to determine whether the regulatory systems are equivalent before the results of the inspection are recognised. “Capable” does not mean that EU and US supervisory authorities have identical procedures. On the contrary, the EU and the FDA determine that the country: one of the main objectives of MRIs is to lighten the burden on manufacturers and reduce the costs and time to market of products by implementing transparent conformity assessment processes while ensuring that products placed on the market comply with FCC rules. NRAs only address the issue of acceptance of conformity assessment results and do not seek to harmonise regulatory requirements or technical standards. Brexit has the potential to complicate matters. The UK is due to leave the EU on 30 March 2019. While the benefits of the MRA are maintained until that date, how the institutions will be treated with the UK as the EU`s reference member state as soon as the withdrawal from the EU is official, given that the UK will then be outside the scope of the agreement.