Mutual recognition agreements (MRAs) promote trade in goods between the European Union and third countries and facilitate market access. These are bilateral agreements designed to facilitate industry access to compliance assessment. Trade agreements are trade agreements designed to facilitate market access and promote greater international harmonization of compliance standards while protecting consumer safety. The agreement, which came into force on 1 January 2002, is Japan`s first bilateral mutual recognition agreement. In April 2016, the Sector Annex on Good Drug Manufacturing Practices (GMP) was amended. In July 2018, the operational scope of the drugs was agreed to include product categories such as chemicals, pharmaceutical active substances, biologics and herbal medicines, etc., under certain conditions agreed by both parties. Mutual recognition agreements set out the conditions under which a party (non-member state) accepts compliance assessment results (for example. B tests or certifications) conducted by the compliance assessment agencies (CABs) designated by the other party to demonstrate compliance with the requirements of the first part (non-member) and vice versa. The EU-Australia Agreement covers the following areas This publication is www.gov.uk/government/publications/uk-japan-exchange-of-letters-on-mutual-recognition/uk-japan-exchange-of-letters-summary The scope of this agreement has been extended to sterile medicines, certain biologic drugs, including vaccines and immunologies, as well as to the pharmaceutical principles (API) of all drugs containing medicines.

This means that the EU and Japanese authorities have agreed that they have an equivalent regulatory and procedural framework for manufacturer inspections of these products and that they can therefore rely on inspections of the other. The new agreement extends it to certain biologic drugs, including immunologies and vaccines, which no longer need to be verified once delivered to each other`s territory. 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 United States, for example, has been particularly interested in extending its mutual agreements with the EU. This announcement builds on a previous agreement signed in May 2004, in which the European Union (EU) and Japan recognise inspections of good manufacturing practices (GMPs) on the territory of the other country. The text of the Protocol on Mutual Recognition of the Results of the Compliance Assessment is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada, on the one hand, and the European Union and its Member States, on the other hand, mutual recognition is a growing trend between different nations, since the benefits of non-compliance with inspection reports reduce the burden on both regulatory authorities, as mentioned in the EMA DECLARATION, and for industry. 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.