Impact of Mutual Recognition Agreement between countries

Mutual Recognition Agreements (MRAs) are trade agreements which prompt two or more countries to accept one another’s conformity assessment certificate.

MRAs not only include drugs and Medical devices. It also includes Telecommunication equipment, electromagnetic compatibility, electrical safety, recreational craft, and so on.

Advantages:

– This trade agreement can have greater impact on international harmonization of regulatory standards or processes

– MRAs avoid duplication of regulatory inspections, thereby saving time and money. Also facilitates easy market access.

Challenges:

– MRA requires certain level of trust between two regulatory bodies which requires certain time to build

– Over dependence on external regulatory authority might pose threat to public health

– Coordination of post market surveillance processes and activities can be challenging. To overcome this, having a single platform for sharing the information might be helpful

– Knowledge flow and peer learning

Factors to consider before MRA:

– Regulatory domains which are science-driven,

– Strong commercial/trade motivations,

– Areas where regulators may benefit from sharing information and knowledge on safety, health, environment and consumer protection aspects,

– Areas where regulators in potential partner countries struggle with similar problems,

– Domains with similar objectives for safety, health, environment and consumer protection and/or similar standards,

– Countries where economic, social, political, technological conditions are assessed as comparable,

– Regulatory domains where, upon regulatory rapprochement, sharing of testing, certification, inspection would be acceptable,

– Domains for which regulatory authorities have ex ante confidence in the regulatory/technical skills in each other,

– Domains for which some bi-or multilateral frameworks exist, including international standards.

Major MRAs between regulatory agencies are given below:

– MRA was signed between European community and United States of America (US-EU MRA) in 1998

– MRA is in place between Australia and European community, which provides for the mutual acceptance of conformity assessment of medical devices