DIA: Global initiative to standardize CMC quality data gaining steam

Regulatory NewsRegulatory News | 22 June 2022 |  By 

CHICAGO – Several initiatives in the works among regulators and the pharmaceutical industry are gaining momentum to harmonize chemistry, manufacturing, and controls (CMC) information submitted in the Common Technical Document (CTD). One such effort is the formation of an industry consortium that is seeking to develop a structured content cloud-based CMC Module 3 template with input from regulators.
 
These plans were discussed on 20 June 2022 during the Drug Information Association’s annual meeting in Chicago, during which officials discussed some of the current challenges related to the submission of Module 3 CMC data.
 
“The problem statement is that even though many companies are global and have a common product … the fact that there are differing regulatory requirements means that there is not a single global dossier. Additionally, once a dossier is submitted, the number of information requests that come in that necessitate changes in one of more of the CTD components, mean there are a lot of maintenance activities that have to be conducted by the marketing authorization holders in the different markets,” said Nina Cauchon, director of regulatory affairs CMC at Amgen, who moderated the session.
 
Greg Rullo, senior director of regulatory affairs CMC at AstraZeneca, concurred. “You are all probably aware that many drug products come out of a few manufacturing sites,” yet these products have to meet different CMC requirements. “We have regulators who have different interpretations of what those standards might be and this leads to a very difficult postapproval environment,” he added.
 
Consortium formed
 
To address some of these challenges, a consortium of pharmaceutical companies was recently established to standardize the CMC information submitted in Module 3.
 
Sheetal Gaiki, a senior scientist with Janssen, called the initiative “a novel CMC content model to provide structured and standardization for CMC data requirements.” Called Accumulus, this initiative is being developed with input from global trade associations and health authorities.
 
Pharmaceutical industry members include Amgen, Astellas, AstraZeneca, GSK, Johnson & Johnson and Roche. Industry members have already met with health authorities and global trade associations to hammer out a structured content model.
 
Global trade association members include the European Federation of Pharmaceutical Industries and Association (EFPIA), the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO), the Product Quality Research Institute (PQRI), DIA Europe and the Parenteral Drug Association (PDA).
 
The effort is being launched under the umbrella of Accumulus Synergy, a global, non-profit organization established in 2020 that develops data exchange platforms and works to improve collaborations between biopharmaceuticals companies and global health authorities.
 
The initiative aims to standardize the information in Module 3 of the CTD such as a common PQ/CMC data information format covering batch or lot information, manufacturing process information, and pharmaceutical quality specifications.
 
The end result will be a product that “will help present content in a structured format in line with the eCTD or future pathways,” said Gaiki.
 
“Accumulus will create reference maps to link the narrative and raw data while allowing each to flow independently, structuring the content, when necessary,” she said.
 
The template would include a core content block, with sub-content blocks for the sponsors, with regulators having a similar core content and sub-content blocks. The information will be stored in the cloud and can be accessed in real-time.
 
FDA making inroads in CMC standardization
 
Complementary efforts are also being undertaken at the US Food and Drug Administration (FDA) to standardize data reviews for CMC information under the agency’s PC/CMC initiative.
 
FDA’s Geoffrey Wu said that this standardization will ensure that industry and FDA are using the same data. “For industry, the benefit provides a consistent format for internal and external data management. For FDA, this initiative ensures the agency receives consistent high-quality data that can be consumed by computer systems without data entry and interpretations.”
 
Currently, all Module 3 information is submitted in a PDF format with unstructured quality information, causing reviewers to hunt and peck through applications for the quality information they need. This format “significantly hinders the efficiency of data exchange, data assessments, quality assessments and lifecycle knowledge management,” Wu said.
 
The ultimate goal is for this data to feed into FDA’s internal review template KASA, Wu said, adding that “This initiative is a significant enabler for KASA.” (RELATED: FDA taking incremental approach to launching KASA reviews, Regulatory Focus 5 November 2021)
 
Phase 1 of the PC/CMC initiative was completed at the end of 2020. In this phase, FDA standardized about 33% of Module 3 data. Under Objective 2, which began in January 2022, FDA is developing a data exchange standard for submission of PQ and CMC data.
 
DIA annual meeting

 

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