Why Mutual Recognition Agreements Matter in Pharmaceutical Regulatory Affairs

pharmaceutical regulatory affairs

Mutual Recognition Agreements, or MRAs, help streamline the regulation of pharmaceuticals by establishing better cooperation between governments. This cooperation means that countries and regions can rely on one another’s testing and regulations of pharmaceutical products, instead of each region repeating the same processes on identical drugs. It’s a more efficient use of time and resources.

Canada has a regulatory authority called the Health Products and Food Branch (HPFB) of Health Canada. The HPFB regulates MRAs that Canada is a part of. MRAs ensure Good Manufacturing Practices (GMPs) are followed and make it easier for people around the globe to access medicine.

Read for more about MRAs and how they will matter for your studies and your career!

Why Pharmaceutical Regulatory Affairs Students Should Know About the HPFB

The HPFB is a scientific, regulatory branch of government, focused on health products along with foods. Within this branch, directorates focus on areas of regulation. The Marketed Health Products Directorate works to:

  • Regulate human health products based on assessment
  • Make information about product risks available to Canadians

This ties into MRAs because the assessments used can sometimes overlap. Inspections and results from different authorities that duplicate each other end up wasting time and resources. With an MRA, this duplication can be minimized.

MRAs help prevent duplicate inspections that are inefficient and unnecessary

MRAs help prevent duplicate inspections that are inefficient and unnecessary

An example of this overlap comes from outside of Canada. Before their agreement, EU and US authorities would occasionally inspect the same manufacturing facility twice within one year. This was inefficient and took time away from other inspections. As a Pharmaceutical Regulatory Affairs student, you can likely guess that this situation meant that inspections weren’t prioritized as well as they could be. An MRA agreed to between the EU and US allows these two authorities to:

  • Reduce waste and inefficiencies
  • Share information
  • Prioritize inspections

How GMPs were Included in the Canada-EC MRA

Learning about GMPs is part of regulatory affairs programs because using them prevent problems from arising and catches potential risks early during production of a drug. These are problems that can’t be dealt with in final testing and need to be minimized sooner, such as:

  • The amount of the active ingredient in a drug
  • Accidental or unforeseen contamination
  • Errors in labelling and packaging
An MRA between Canada and Europe monitors Good Manufacturing Practices

An MRA between Canada and Europe monitors Good Manufacturing Practices

GMPs were included in an MRA that was agreed to between Canada and Europe for these very reasons. That MRA has since been incorporated into the Comprehensive Economic and Trade Agreement (CETA) between Canada and the EU.

The inclusion of GMPs in MRAs is important for the global pharmaceutical market. This market is expected to continue growing, having done so at a rate of 6.3% from 2014 to 2018. According to the World Health Organization (WHO), most countries will only import drugs that follow GMPs that are internationally recognized, which is why MRAs help to foster growth in the global pharmaceutical market.

Why Everyone with Careers in Regulatory Affairs Benefits from MRAs

MRAs mean that more drugs can be trusted, as products that weren’t manufactured in Canada are following the same guidelines. This also benefits authorities of regulatory affairs, as the more countries involved in an agreement, the more access to information there is. For example:

  • Relationships are developed between regulatory authorities
  • Evaluation of standards is done cooperatively
  • Ongoing communication between authorities creates mutual accountability that keeps standards and compliance high

Overall, MRAs raise industry standards, increase efficiency and facilitate relationships across borders. They improve the global market and can result in better quality and safety of products. If you’re considering working in regulatory affairs, you’ll want to keep an eye on the development of new and existing MRAs.

Agreements between governments help build relations among global regulatory agencies

Agreements between governments help build relations among global regulatory agencies

Are you interested in programs for careers in regulatory affairs?

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