CDER Plots Established Conditions Pilot
Regulatory News | 14 February 2019 |
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Thursday announced a new pilot program where sponsors can propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).
Building off a draft guidance issued in 2015 on ECs and reportable chemistry, manufacturing, and controls (CMC) changes, and the International Council for Harmonisation’s (ICH) draft Q12 guidance, FDA said the pilot is meant to build the agency’s experience in receiving, assessing and engaging with applicants regarding proposed ECs.
“FDA will accept nine requests submitted before May 30, 2019 from applicants intending to submit NDAs, ANDAs, or BLAs, either original applications or prior approval supplements, with proposed ECs,” the agency said in Thursday’s Federal Register. The submission of the application should be planned for receipt by FDA no later than 1 July 2019.
Background
In the 2015 FDA guidance, the agency defines ECs as “the description of the product, manufacturing process, facilities and equipment, and elements of the associated control strategy as defined in an application, that assure process performance and quality of an approved product.” Changes to such ECs must be reported to FDA.
The definition aligns with ICH’s Q12 guidance, which notes that: “ECs are legally binding information (or approved matters) considered necessary to assure product quality. Consequently, any change to ECs necessitates a submission to the regulatory authority.”
In addition, the ICH Q12 guidance describes how an applicant can identify and propose so-called “explicit” ECs in which the EC itself or the reporting category for the EC, if changed, differs from existing requirements as described in regulations and guidance.
“Such explicit ECs should be supported by an appropriate justification that takes into consideration the applicant’s development approach and risk to product quality. FDA recognizes that this process will be new for both applicants and Agency staff. Therefore, FDA is proposing this pilot program,” the Federal Register notes.
Pilot
FDA notes four objectives for the pilot: gaining experience in assessing explicit ECs, engaging with applicants during a review cycle to refine such ECs, ensuring user fee timeframes are accounted for in such assessments and identifying agreed-upon ECs at the time of approval.
FDA further encourages applicants who are accepted into this pilot to pursue pre-submission meetings with the agency.
And although FDA’s Center for Biologics Evaluation and Research (CBER) is not involved in the pilot, FDA said the center intends to leverage CDER’s experience as CBER assesses explicit ECs in future submissions. To learn more about how to participate in the pilot, see the Federal Register notice below.
Federal Register
Building off a draft guidance issued in 2015 on ECs and reportable chemistry, manufacturing, and controls (CMC) changes, and the International Council for Harmonisation’s (ICH) draft Q12 guidance, FDA said the pilot is meant to build the agency’s experience in receiving, assessing and engaging with applicants regarding proposed ECs.
“FDA will accept nine requests submitted before May 30, 2019 from applicants intending to submit NDAs, ANDAs, or BLAs, either original applications or prior approval supplements, with proposed ECs,” the agency said in Thursday’s Federal Register. The submission of the application should be planned for receipt by FDA no later than 1 July 2019.
Background
In the 2015 FDA guidance, the agency defines ECs as “the description of the product, manufacturing process, facilities and equipment, and elements of the associated control strategy as defined in an application, that assure process performance and quality of an approved product.” Changes to such ECs must be reported to FDA.
The definition aligns with ICH’s Q12 guidance, which notes that: “ECs are legally binding information (or approved matters) considered necessary to assure product quality. Consequently, any change to ECs necessitates a submission to the regulatory authority.”
In addition, the ICH Q12 guidance describes how an applicant can identify and propose so-called “explicit” ECs in which the EC itself or the reporting category for the EC, if changed, differs from existing requirements as described in regulations and guidance.
“Such explicit ECs should be supported by an appropriate justification that takes into consideration the applicant’s development approach and risk to product quality. FDA recognizes that this process will be new for both applicants and Agency staff. Therefore, FDA is proposing this pilot program,” the Federal Register notes.
Pilot
FDA notes four objectives for the pilot: gaining experience in assessing explicit ECs, engaging with applicants during a review cycle to refine such ECs, ensuring user fee timeframes are accounted for in such assessments and identifying agreed-upon ECs at the time of approval.
FDA further encourages applicants who are accepted into this pilot to pursue pre-submission meetings with the agency.
And although FDA’s Center for Biologics Evaluation and Research (CBER) is not involved in the pilot, FDA said the center intends to leverage CDER’s experience as CBER assesses explicit ECs in future submissions. To learn more about how to participate in the pilot, see the Federal Register notice below.
Federal Register
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