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Indian pharma sees US FDA’s remote regulatory assessment to reduce delays in approvals

Nandita Vijayasimha, Bengaluru
Monday, February 12, 2024, 08:00 Hrs  [IST]

The Indian pharmaceutical industry is of the view that the US FDA’s remote regulatory assessment (RRA) will reduce delays in approvals. The global regulatory authority which issued a draft guidance titled ‘Conducting Remote Regulatory Assessments’ has sought industry comments before March 31, 2024. It has noted that it was the Covid pandemic that brought in this to ensure approvals for new drug and medical devices that could be approved in a time-bound manner. RRA is implemented for a virtual assessment of production plant compliance with applicable FDA requirements.
 
Digital technologies adopted in the remote conduct of inspections proved valuable in the protection of public health during the pandemic. Yet there are observations that such virtual meetings between industry and the regulatory authority to be not so conducive in terms of information sharing. This is because of postponements of remote inspections took place because of concerned personnel being absent and leading to no access to documents. Even with these experiences, US FDA now has noted the value of RRAs and concluded that it should be used for certain scenarios outside the Covid-19 pandemic and for all types of FDA-regulated products.
 
To this end, the draft guidance is developed to provide answers to frequently asked questions related to RRAs. When finalized, this guidance is intended to help enhance industry’s understanding of RRAs, thereby facilitating the global regulator to conduct this.
 
According to Indian pharma, RRAs are welcome. They are time saving and makes the industry efficient in terms of manpower presence and documentation submission. If done right will bring in transparency, accountability and trust of the global regulator.
 
Kaushik Desai, a pharma consultant, said, “This is an excellent positive learning from the experience of the Covid times and is expected to expedite the process benefiting pharma industry in deliverables.”
 
Many a time it is seen that global regulator’s enforcement wing mandate records to be submitted in advance of a live remote interaction or inspection. These cover Foreign Supplier Verification Programme (FSVP) records, voluntary RRAs involving remote requests for interactive evaluations such remote live-streaming video of operations, teleconferences, and screen sharing. Here FDA stated that it has helped in verifying corrective actions taken in response to inspections of previously compliant.
 
It should be noted that some regulatory agencies are currently evaluating whether to utilise remote approaches going forward. Nevertheless US FDA has indicated that remote approaches could continue to be a tool in the inspection ‘toolkit’ of regulatory authorities, post pandemic.
 
FDA uses a variety of tools for oversight of its regulated products and establishments.

Further RRAs have also provided information about deficient practices, leading to take regulatory actions as well as informing future inspection planning.

RRAs were used to help support review and promote timely approval or authorization of marketing submissions Based on these experiences, FDA has determined that RRAs are valuable and should be continued to assist it to protect public health, oversee regulated industry, and ensure all types of regulated products comply to provide further transparency to stakeholders.

Large Indian pharma is of the view that they are ready for RRAs over the medium-small enterprises which need to come a long way because it is more of a data-driven process where data analytics identify deviations.

As part of the RRA process, FDA intends to ordinarily prepare a report consisting of a narrative and supporting documents that communicate the summary of information reviewed, conditions and practices found, and the observations identified.

 




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