QuestionsQuestions (FDA Circular No. 2015-001)
It clarifies and reiterates the regulations governing principal and identical drug products, addressing technical issues on their required “similarity/identity” so that unnecessary duplication of technical dossier evaluation is avoided while still protecting safety, efficacy, and quality.
It requires identical drug formulation having the same name(s) and amount(s) of active medicinal ingredients per dosage unit, excipients, components, and manufacturing process as the principal product.
Color, scoring, imprints, and embossed/debossed marks (among others) must be uniform for both principal and identical drug products.
It means the physical markings on the dosage form cannot include brand names or anything that would clearly indicate or be associated with the brand identity of the principal product, to prevent misbranding of identical drug products.
FDA shall deny the applications outright, and applicants will be advised to file for full registration (regular CPR) under existing rules and regulations.
Starting 30 November 2014.
They must apply for the appropriate variation (e.g., change of capsule color) so that their products are identical with the principal product, either prior to or during renewal of their authorizations.
They must apply for the appropriate variation so that they will comply with the prohibition on brand-identifiable markings on the dosage form.
Until 30 March 2015.
Renewal applications will be disapproved and the products may be withdrawn from the market.
Yes. The definition includes identical name and amount of active medicinal ingredients per dosage unit, excipients, components, and the manufacturing process.
It preserves the alternative pathway for identical drug products (listing with reduced requirements) only when true identity is met; otherwise, full registration is required because technical similarity cannot be assumed.
The pathway is the listing of identical drug products through a Certificate of Listing of Identical Drug Product (CLIDP) based on the identity of manufacturer and pharmaceutical formulation, together with the concept of Principal Certificate of Product Registration (PCPR).
Principal products are covered by the Principal Certificate of Product Registration (PCPR), while identical drug products are covered by the Certificate of Listing of Identical Drug Product (CLIDP).
The applicant must apply for full registration, i.e., obtain a regular Certificate of Product Registration (CPR) in accordance with existing rules and regulations.