CMC regulatory affairs provides regulatory leadership and strategy to achieve approval of drug formulations. It ensures the proper characterization, quality, purity and potency of drugs through testing and compliance with regulatory requirements. CMC regulatory submissions contain detailed information on manufacturing, analytical methods, quality control and stability testing to support clinical trials and marketing applications for drugs. Regulatory agencies like the FDA and EMA evaluate CMC data at various stages of IND and approval processes to ensure patient safety.

1. CMC(CHEMISTRYMANUFACTURINGANDCONTROL)
The results of preclinical testing are used by experts in
pharmaceutical methods to determine how to best formulate the
drug for its intended clinical use. Regulatory agencies require
testing the characteristic such as chemical composition, purity,
quality and potency of the formulated drug.
CMC regulatory affairs is a specific area with RA that has
ultimate responsibility for providing CMC regulatory leadership and
strategy required to achieve regulatory approvals.

2. CMC RA provides knowledge, understanding, interpretation and
utilization of regulatory guidance and regulations, as well as
industry and government agency best practice and trends.
CMC RA is a high value added function within a company that
is critical to successful development, registration, approval and
lifecycle management of pharmaceutical product.
Example: CMC regulatory submission may contain information
associated with API and the finished dosage form including,
Names and location of manufacturing and testing sites.
Characterization of the API and composition of the dosage form.

3. Raw materials used to manufacture the API and finished dosage
form.
Description of the product and process development.
Description of the manufacturing process.
Analytical methods and specifications used for testing and release
of raw materials, in process controls, container and closure system,
API and dosage form.
Quality testing, bio equivalence testing.
Release and stability testing data for both API and the dosage form.

4. CMCREGULATIONAFFAIRS:
Government regulatory agencies involved in the approval process
are:
1. The food and drug administration (FDA)
2. European medicines agencies (EMA)
3. Japanese pharmaceutical and medical devices agencies (PMDA)
 As a strategic function, CMC RA collaborates closely with
multiple scientific, technical, quality, and commercial areas
within a company or with external contract manufacturing
organization (CMOs)

5. Information regarding CMC for drug is important and detailed
section in a dossier to support clinical studies and marketing
applications and this information should be updated throughout
drugs lifecycle.
REGULATION
21 CFR 312.23 (a)(7)(i)
Appropriate for the particular investigation covered by IND, a
section describing the composition, manufacture and control of the
drug substance and the drug product sufficient CMC information to
assure the proper identification, quality, purity and strength of
investigational drug.

6. CMCREVIEWATINDSTAGES:
 Primary objectives is to assure the safety of patients, during all
phases of the IND
 PHASE 1 CMC evaluated mainly from the point of risk to
patient.
 PHASE 2 and 3 CMC evaluates and additionally the linkage of
the clinical test product to be marketed product.

7. CMCREGULATORY SERVICES:
Preparation and review of regulatory submission including;-
Investigation new drug (IND)
Clinical trial authorization (CTA)
Investigational medical product dossier (IMPD)
New drug application (NDA)
Marketing authorization application (MAA)
Abbreviated new drug application (ANDA)
Authority of annual reports, drug master files dossier amendments
and supplements.
Preparation publication and submission of eCTD application
(electronic common technical documents).
Direct interaction and negotiation with US, FDA, EMA and
national agencies.