The Center for Drug Evaluation (CDE) released the “Marketed Chemicals Pharmaceutical Changes Study Technical Guidelines (Trial)”, “Marketed Chemicals and Biological Products Clinical Changes Technical Guidelines”, and “Chemicals Changes Acceptance and Review (Trial)” guidance. The documents relate to pharmaceutical changes including changes in the formulation of auxiliary materials, changes in the production process of active pharmaceutical ingredients (APIs) and formulations, changes in production sites, changes in production batches, changes in suppliers of APIs used in formulations, changes in registration standards, changes in packaging materials and containers, changes in expiry dates and storage conditions, increased specifications, and others.
Changes are divided into major, medium, and minor. Major changes are divided into category A (changes in drug safety and efficacy information) and category B (changes in information related to the safety of drug inserts). Category A changes are related to the medication population, efficacy, safety, dosage, and administration of the drug. Category B changes will not change the approved indications or usage and dosage. Moderate change refers to the revision of the instructions according to the announcement or approval from the National Medical Products Administration (NMPA). Minor changes amount to the revision of the administrative information in the drug insert, with safety and efficacy information left intact.
Drug information change filings shall be accepted for review by the CDE. The applicant is advised to submit electronic and paper filings via the submitting software mandated by the NMPA. For drugs with conditional approvals, MAHs shall complete clinical trials and other studies within certain periods and submit the change filings as a supplementary application. For changes to marketed chemical drugs, the applicant shall carry out a comprehensive evaluation based on relevant technical guidelines and select the appropriate changes.
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