A New Drug GMP Mutual Recognition Agreement Model

A pilot between three drug regulators aims to target aspects of good manufacturing practice (GMP) inspections to include better coverage of what each regulator would like to see evaluated. A feature of this pilot not common to most Mutual Recognition Agreements (MRAs) is a planning phase to ensure the regulator performing the inspection covers the systems and products the other two want assessed.

This “single inspection program pilot” has just begun and is the result of an agreement between Health Canada, Australia’s Therapeutic Goods Administration (TGA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

As with any inspection MRA, a primary goal is to reduce the number of inspections at manufacturing sites thus decreasing the burden on the facilities being inspected and the agencies inspecting them and avoiding duplication of effort.

Two of the regulators – Health Canada and TGA – also announced a Memorandum of Understanding (MoU) that decreases the regulatory burden for companies seeking approval of products marketed in both Canada and Australia.

At the 48th annual International GMP Conference held in early March 2024 at the University of Georgia in Athens, Georgia, Health Canada Acting Associate Director of Health Products and Licensing Divisions Teresa Forlini and MHRA Senior GMP Inspector and Manager of Inspectorate Risk, Control and Governance Ian Jackson commented on the new inspection pilot program.

New Pilot Could Be a Model for Other Regulators

Forlini explained that for a company to market a drug product in Canada or be part of the drug supply chain – for example, a wholesaler, packager, importer, or contract lab – the company must have a Drug Establishment License (DEL). At present, there are roughly 950 active DELs in Canada and about 50 to 55 Health Canada inspectors to cover them.

“Canada needs to be able to have the proper oversight over all the buildings that are involved in the supply chain for Canadian drugs,” she emphasized. To help accomplish that, “we continue to rethink the way we do business with our partners.”

To aid its small inspectorate in inspecting all the players in its market, Health Canada has worked with TGA and MHRA to design and launch a new “single inspection program” initiative. It is the result of discussions between the agencies on ways to collaborate and share the inspection workload.

What are the key features of the pilot? “It is a coordinated effort,” Forlini said. “These three regulators will find sites of common interest. What we have agreed to do is that only one of the regulators will go onsite to do the inspection, but they will cover the scope or the products of the other two regulators.”

When the inspections are complete, “we are assured that the products have been fully inspected and we will accept everything as done.”

Although Health Canada has had a Mutual Recognition Agreement with TGA since 2006 and with post-Brexit MHRA since 2022, “sometimes we could not depend on an inspection report because it did not cover the Canadian product,” Forlini explained. “If it was not sold in their market, they would not inspect it.”

She characterized the new single inspection pilot as “a huge accomplishment for us. We are very happy to be working with them. And we hope it is going to be useful in the future for other opportunities.”

During a Q&A session at the Georgia conference, MHRA Senior GMP Inspector and Manager of Inspectorate Risk, Control and Governance Ian Jackson participated virtually and also commented on the pilot.

“It really talks to the vision of what a global inspection means,” he said. “It is about planning for the inspections, knowing who is going where, and discovering each other’s needs and common interests.”

He further commented that “the GMP standards are the same.”

See the related story on the MoU between Health Canada and TGA that simplifies the approval of products marketed in both countries.