Question & AnswerQ&A (FDA Circular No. 2015-001)
Its primary purpose is to address concerns of unnecessary duplication of technical dossier evaluation in the registration of identical drug products, allowing an alternative registration pathway with reduced requirements based on the principal product's assured safety, efficacy, and quality.
Identical drug products are defined as having identical drug formulation and manufacturer/source of finished product with that of the principal product.
It means having the same names and amounts of active medicinal ingredients per dosage unit, excipients, components, and manufacturing process as the principal product.
PCPR is the main certificate for the original product registration. CLIDP is a certificate granted to identical drug products allowing their registration with significantly reduced documentation requirements.
They must ensure compliance with the provision that identical drug formulations (including color, scoring, imprints, embossed/debossed features) are uniform with the principal product; branded principal products must not have brand names or markings identifiable to the brand on the tablet/capsule surface.
Such applications will be denied outright and applicants will be advised to apply for full registration via a regular Certificate of Product Registration (CPR).
They are required to apply for appropriate variations, such as changes to capsule color, to ensure identity with the principal product before or during renewal of their authorizations.
They must apply for the appropriate variation to comply with the uniformity requirement.
The deadline is until March 30, 2015.
Failure to comply will mean disapproval of renewal applications and subsequent withdrawal of the products from the market.
To avoid misbranding of identical drug products, ensuring that the identical drugs do not reflect brand marks that can confuse the market.
Misbranding refers to marketing a drug product with marks or branding that cause confusion, especially when identical drugs are involved, compromising product uniformity and regulatory clarity.