US, Canada Announce Extensive New Harmonization Efforts

Posted 30 July 2012 | By Alexander Gaffney, RAC 

The White House's Office of Management and Budget (OMB) has announced the next stage in a regulatory harmonization agreement first launched in early May 2012 between the US and Canada, with life science regulations expected to enter into a process of harmonization between the two countries.

The 30 July announcement by OMB includes four regulatory areas scheduled for harmonization: an electronic submission gateway, common monographs for over-the-counter (OTC) drugs, good manufacturing practices and a new animal drug submission process.

In a statement, FDA and Health Canada (HC) said, "A goal of collaboration between HC and FDA is to better align our regulatory systems, reduce unnecessary duplications and differences and, to the extent feasible, better leverage resources to help both agencies meet their public health missions within the parameters allowed by prevailing laws and regulations subject to available human and financial resources."

As part of that collaborative effort, the two agencies said they are in the process of outlining "key elements" to promote a "systemic alignment of regulatory systems, strategies and practices."

OMB said in a separate statement that it expects, "By reducing unjustified disparities and needless red tape, these initiatives will have a positive impact on economic growth," by "cutting red tape."

Electronic Submission Gateway Heralds 'Increased Review Collaboration'

The first planned collaboration between the two agencies involves the expansion of the US' electronic submission gateway (ESG), which is used by industry to submit pharmaceutical dossiers electronically to the agency without having to send a paper version of the same documents to the agency.

Under the new plan, HC and FDA would use the same gateway-renamed the Common Electronic Submission Gateway-which could accommodate the needs of both agencies while, "Catalyzing increased review collaboration between the two regulatory agencies."

While the product remains in the planning stage-and according to regulators, is likely to remain in such a stage for an additional 3-6 months-the arrangement would be part of a "permanent collaboration enabled by the ESG mechanism."

The groups also said they plan to, "Engage industry and the FDA through venues such as the PhRMA ERS Working Group and the Group on Electronic Regulatory Activities (GERA) to identify other potential collaboration opportunities that the ESG may enable." FDA and HC hope to begin a pilot program with industry within the next 6-12 months, they said, with the pilot serving to "verify the functionality, reliability and efficiency" of the proposed ESG program.

Over the long term-12-18 months-both agencies said they also intend to identify other opportunities to work together, including the harmonization of orphan drug and drug master file submission content requirements, and work to harmonize drug review processes and data standard requirements.

The agencies also said they plan to implement an electronic reporting project for adverse drug reactions, with "the goal being alignment to a single solution for ESGs to Health Canada."

OTC Monographs to Potentially Include Identical Labeling

An additional set of proposals put forth by HC and FDA involve harmonizing OTC monographs between the two countries, including labeling requirements, indications, warnings, conditions of use and, "Any other information that may be required for optimal, safe and effective use of the product."

Regulators said the proposal holds the promise of being able to, "Streamline costs for manufacturers and distributors and enhance consumer access to these types of therapeutic products on either side of the border."

To initiate the pilot phase of the project, a single product's monograph will be selected at approximately 3-6 months into the project, with the subsequent 6-15 months being spent finding ways to align the two products in a way that allows for the greatest harmonization and the mitigation of potential problems.

The agencies said they hope to have the project completed within two years.

GMP Inspections Move Toward 'Mutual Reliance'

Good manufacturing practices (GMPs) are the focus of a third proposal by the regulators, who said they wish to enter a phase of "mutual reliance" for inspections within the next 18 months.

Under the plan, HC and FDA would establish a "joint GMP database used as a common repository to foster standardized sharing of GMP inspection reports," and would regularly exchange inspection reports and data to reduce inspection duplication.

The inspection cooperation would extend to third countries, such as those in developing nations, where either regulatory authority would rely on the findings of the other one.

As with the other cooperation programs proposed by HC and FDA, the GMP mutual reliance program will slowly ramp up, with a 6-month planning stage followed by a 6-to-12-month pilot phase during which information will begin to be shared on a limited basis.

Veterinary Drugs to Include 'Simultaneous Review' Process

The fourth and final area of regulatory cooperation proposed between the two agencies involves veterinary drugs, which HC and FDA said could stand to benefit from simultaneous introduction into marketing and a collaborative review process.

"In addition, this initiative will see … the establishment of comparable human food safety standards for veterinary drugs," the regulators added. Within six months, HC and FDA hope to have identified a potential drug candidate for "simultaneous review of [the] Human Food Safety technical section," with approval of the product occurring within 18 months of submission.

In the long term, both agencies said they will be looking to, "Continue working toward simultaneous and collaborative review of submissions for sponsors," and will create a joint Center for Veterinary Medicine (CVM)/Veterinary Drugs Directorate (VDD) working group to draw up the process.

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