Mutual Recognition Agreements

Requires FDA support of efforts to move towards the acceptance of mutual recognition agreements between the European Union and the United States. 

Australia and the EC have entered into a Mutual Recognition Agreement (MRA) on conformity assessment of medicinal products. The TGA will accept a certificate of GMP compliance of a manufacturer issued imder this MRA by the official inspection services of the EU countries. This follows on from Australia s work over many years with the Pharmaceutical Inspection Convention, now known as the PIC/S. 

Globalization, harmonization, standardization, uniformity, and mutual recognition agreements are all prevailing trends that significantly affect compliance in the pharmaceutical, medical device, and biotechnology industries. 

Japan. EU-Japan Mutual Recognition Agreement, 1 January 2002. Sectoral Annex on Good Laboratory Practice (GLP) for Chemicals, http //www.mofa.go.jp/region/ europe/eu/agreement-glp.pdf... 

AU this makes good business sense and should eliminate the need for corrective work because of misunderstood validation requirements. Similar harmonization would appear to be occurring on the topics of electronic records and electronic signatures. Mutual Recognition Agreements (MRAs) between various national regulatory authorities such as the FDA, MHRA, TGA, and MHLW and the work of the International Conference for Harmonization (ICH) offer an opportunity to formally consolidate harmonized computer validation requirements. 

Qther interesting features of the Canadian system include its 1998 mutual recognition agreement with the EU, prohibition of prescription drug advertising to consumers, a 20-year patent exclusivity period, and the establishment of the PMPRB to ensure fair pricing of medications. ... 

Canada also initialed a Mutual Recognition Agreement with the EU covering good manufacturing practice (GMP) audits. Accordingly, once the equivalency of the Canadian and European GMP audit procedures have been established, products can enter the respective markets without the need of mutual inspections of the producing facilities in each other s territories. 

There are no formal mutual recognition agreements with other national or multinational regulatory bodies in areas such as mcirketing authorizations, good manufacturing practice (GMP) and batch control. 

Under the EUs Mutual Recognition agreement, apphcant companies can achieve multistate clearance within Europe after just one member state approves their product. This decentralized approach enables apphcants to choose which national authority will handle preregistration documents and to designate where and when subsequent marketing authorization will be sought (specified countries versus the pan-European mandate). 

A current prerequisite to NDA approval in the United States is to have successfully passed a FDA PAI. In the future, the Mutual Recognition Agreement (MRA), if agreed on, may eliminate the need for FDA inspections in Europe and Japan. 

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