FDA Rules on Principal and Identical Drug Products

Administrative Order No. 2005-0031 establishes the Guidelines and Procedure for the Issuance of the Principal Certificate of Product Registration and the Listing of Identical Drug Products based on the identity of manufacturer and pharmaceutical formulation.
The circular clarifies compliance requirements under the principal certificate of product registration (PCPR) and certificate of listing of identical drug product (CLIDP) framework created by Administrative Order No. 2005-0031.
The circular addresses technical concerns affecting similarity between principal and identical drug products in relation to the listing pathway.

FDA Circular No. 2015-001 is issued to clarify rules governing principal and identical drug products.
The circular targets concerns that listing identical drug products could lead to inadequate technical assurance if the principal and identical products are not truly identical in formulation and presentation.

Identical drug formulation means having the same name(s) and amount(s) of active medicinal ingredients per dosage unit, excipients, components, and manufacturing process as the principal product.
Identical drug formulation compliance covers uniformity of product presentation features, including color, scoring, imprints, and embossed/debossed markings.

The circular applies to all marketing authorization holders (MAHs) and applicants of principal and identical drug products.
The circular governs CLIDP filings and the continued compliance of previously approved CLIDPs.
The circular also covers principal products bearing brand-related surface markings that could cause misidentification or misbranding.

For all principal and identical drug products, an identical drug formulation must be complied with as defined by Administrative Order No. 2005-0031 and clarified in FDA Circular No. 2015-001.
Presentation elements must be uniform between the principal and identical products, including color, scoring, imprints, and embossed/debossed features.
Branded principal products must not have tablet/capsule surface brand name or markings that are identifiable or synonymous to the brand name on the tablet/capsule surface when the identical drug product is involved, to avoid misbranding.

Incoming applications for CLIDP starting 30 November 2014 must ensure compliance with the uniformity and identical formulation provisions reiterated by FDA Circular No. 2015-001.
If a CLIDP application does not comply with these provisions, the application is denied outright.
Denied CLIDP applicants must be advised to apply for full registration, meaning a regular Certificate of Product Registration (CPR) under existing rules and regulations.

Previously approved CLIDPs must apply for the appropriate variation (e.g., change of capsule color) to make the identical product identical with the principal product.
Previously approved CLIDPs must complete the variation prior to or during the renewal of their respective authorizations.
Principal products bearing the brand name or any markings identifiable or synonymous to the brand name on the tablet/capsule surface must apply for the appropriate variation.

Variation applications must be filed until 30 March 2015.
Failure to comply with the variation requirement by 30 March 2015 results in disapproval of renewal applications.
Failure to comply by 30 March 2015 results in subsequent withdrawal from the market.

MAHs and applicants must implement the clarified requirements for principal and identical drug products for strict compliance.
Regulated parties must ensure that CLIDP applications beginning 30 November 2014 meet the uniformity and identical formulation standards before submission.
Regulated parties must ensure that renewal and authorization continuity is not impaired by missing the required variations by 30 March 2015.

FDA Circular No. 2015-001 is signed by Atty. Nicolas B. Lutero III as Assistant Secretary of Health, OIC, Food and Drug Administration.