Chemistry, Manufacturing, and Controls (CMC) refers to the methods, facilities, and materials involved in the development of a final drug substance and drug product. In most major FDA applications, detailed reports of these processes are a requirement for being approved. For most drug developers, the CMC component of the drug development process can serve as a major hurdle to overcome, as agency requirements for these processes are highly detailed and require full reporting of all steps involved. Thus, the CMC portion of an application can be a potential source of pitfalls for a sponsor.
CMC Function
The CMC procedure ensures the consistency, purity, and stability of each batch of drug product created. These aspects are vital for maintaining a reliable safety and efficacy profile which is consistent for all batches of the drug. This also includes verifying whether the “chemistry and composition of the drug substance, drug product, or the manufacture of either might suggest any possible human risks.” Any inherent risks should be detailed, and there should be a plan included for addressing such safety issues. In addition, if there is a discrepancy between the drug product planned for use in clinical studies and the product used in animal toxicology studies, then those differences must be described.
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CMC Regulatory Strategy
A proper CMC regulatory strategy will provide all the necessary information for approval at every stage of the application process. A successful IND application includes the CMC information for:
- The drug substance
- The drug product
- The placebo
- Labeling information for the labeled products relevant to the investigational drug, if applicable
- An environmental analysis for assessment of the effects of the investigational new drug or biological product on the environment
*See FDA IND Applications for Clinical Investigations: Chemistry, Manufacturing, and Control (CMC) Information table
This information will be submitted within the IND application and must be sufficient to assure the proper identification, quality, purity, and strength of the investigational drug. The precise content required to make that assurance will vary depending on the stage of investigation, the formulation in question, and the duration of the investigation.
A proper CMC strategy requires in-depth knowledge of current CMC regulatory practices. Accurate presentation of information, verification of experts, and a plethora of supporting documents are just a few aspects of the CMC approval process. Recruiting professional guidance is often paramount for an expeditious and untroubled approval. However, sponsors can also investigate the several documents the FDA produces aimed at guiding the approval process.
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Current CMC Guidance Documents for FDA Approval
These FDA Guidance documents for Industry documents provide nonbinding recommendations for conducting successful drug approval.
- Guidance for Industry cGMP for Phase 1 Investigational Drugs can assist in applying current good manufacturing practice (CGMP) in the manufacturing of most investigational new drugs used in phase 1 clinical trials.
- Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information guides sponsors through the CMC requirements during phase 2 and phase 3 studies.
Guidance for Industry IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information primarily covers the three types of meetings that may be held between sponsors and the FDA as related to CMC.
FDA Meetings for CMC Review
These meetings are conducted primarily between the sponsor and one of the two evaluatory divisions at the FDA: the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). A quality CMC submission rests in part on the success of these meetings. It is vital for application approval that these meetings are adequately prepared for.
Pre-investigational new drug application (pre-IND)
The purpose of pre-IND meetings is to discuss CMC issues as they relate to the safety of an investigational new drug proposed for use in initial clinical studies. While pre-IND meetings may be uncomplicated (regarding CMC processes) when the product is straightforward, this does not mean pre-IND meetings don’t require preparation.
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End-of-phase (EOP) Meeting
The purpose of the EOP meeting, with respect to CMC information, is to allow the sponsor and the applicable FDA division to:
- Evaluate the results of the drug development program to date
- Discuss the sponsor’s plans and protocols relative to regulations, guidances, and Agency policy;
- Identify safety issues, scientific issues, and/or potential problems and resolve these, if possible, prior to initiation of phase 3 studies
- Identify additional information important to support a marketing application.
Pre-new drug application (pre-NDA) or pre-biologics license application (pre-BLA)
The purpose of the pre-NDA and pre-BLA meeting is to discuss any filing and format issues and ensure a complete submission as it relates to CMC.
Achieve CMC Success with BioPharma Global
BioPharma Global’s team of industry experts assist companies and individual clinicians in navigating the CMC process in multiple applications. Lack of expertise and attention to detail during this process can result in delayed applications and can cost your organization time and money along with derailing treatment. This situation is avoidable; schedule your free consultation today.
