FDA welcomes joiners to API regulatory sharing scheme

By Natalie Morrison

- Last updated on GMT

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FDA welcomes joiners to API regulatory sharing scheme
The FDA says it expects more boards to join an inter-regulatory API (active pharmaceutical ingredient) inspection programme after simplifying the sign-up process.

Working collaboratively with five other regulatory bodies across Europe and Australia, the FDA (US Food and Drug Administration) has been hatching a scheme since 2008 which will see inspection duties for API manufacturing facilities shared​.

Now after publishing the terms of reference​ – detailing the requirements to join as well as solidifying the purpose of the programme – the board says joining the force is easier and quicker.

Sarah Clark-Lynn, from the FDA office of public affairs, told in-PharmaTechnologist that the most recent member, the World Health Organization (WHO), joined this year​ as a direct result of the terms of reference’s creation.

She said: “The API programme was in the pilot phase until about a year ago. During that time, the participants discussed how best to include other parties, ultimately agreeing on an application process to help ensure transparency and consistency.

“Once the participants agreed on the terms of reference and the WHO provided the required information, the approval process was actually expeditious.”

WHO was the fifth addition to the team of regulators, joining the EMA (European Medicines Agency), the European Directorate of the Quality of Medicines and Healthcare (EDQM), Australia’s Therapeutic Good Administration (TGA), as well as the FDA.

Now the boards hope improved clarity of the system will attract more member states.

When asked if there was a need to involve more Eastern regulators such as the SFDA (Chinese state FDA) or Indian body the CDSCO (Central Drugs Standard Control Organization), Clark-Lynn replied: “There are various advantages to inter-agency collaboration, including reduction of duplicative inspections.

“The API programme participants span three continents and reach hundreds of API manufacturers across the world.

“The terms of reference were created in part to propose the requirements for inclusion, and all regulatory agencies who meet these requirements are invited to apply.”

The secret obstacle

Those behind the effort to globalise regulation of drugs manufacturing have warned the Trade Secrets Act could put the blocks on sharing manufacturing information with other regulators.

Speaking at a Congress subcommittee hearing to discuss generic and biosimilar user fees earlier this year​, senior policy advisor to the FDA, Peter Beckerman, said: “It’s critical to be able to share information with regulatory partners if we want to take advantage of their regulatory reach and be as efficient as possible”.

He added that sharing information about manufacturing processes with other boards is not like sharing the “secret formula for Coke”,​ and said the added capabilities would be “crucial”​ to the pharma industry.

When in-PharmaTechnologist asked if there is any progress in changing the law, the FDA simply said it cannot comment on whether Congress would act.

However, contrary to Beckerman’s belief that the Act is a brick wall for development, Clark-Lynn told us it has not “significantly”​ limited the collaboration so far.

“When we share regulatory documents with partners who have confidentiality agreements in place with the FDA, we have to make only very limited redactions, such as of trade secret information,”​ she said.

“Redaction of trade secret information takes time and reduces substantive content but this has not significantly limited our collaboration.”

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