Data Requirements for Old ProductsGenerics Bioequivalence A Perspective

Data Requirements for Old Products/Generics, Bioequivalence. A Perspective from Argentina 6 th VICH Outreach Forum MV Carlos FRANCIA CAPROVE – Cámara Argentina de Productos Veterinarios

Introduction • How is a product registered in almost all CAMEVET? – The veterinary medicines register system is based on the «new product» concept. Every product, innovative or not, are under the same kind of requirements. – To register a “new product”, the owner has to submit a complete application form.

Introduction

Application form • The application form is a detailed list of requirements that must be fulfilled. • It has four parts – Administrative data – Quality – Efficacy – Safety

Innovative vs. Old products • Innovative products – New API combination – New formulation with different PK • “Old products” – Old and well known API (or API combination) – Well known formulations

All products • Administrative data includes (imported products) – FSC – Establishment license – GMP certificate • Quality data must be referred to the proposed product.

Old Products Requirements • Efficacy and Safety – The information needed can be obtained from technical published works – If the product is included in national erradication programs (like mange or bovine ticks), local efficacy and safety tests could be mandatory. Some of these tests are performed by the regulatory authorities

Bioequivalence • Proposed uses – Significant changes in formulation (excipients or process) that could affect bioavailability – New administration route for a registered product • Under discussion – Avoid efficacy or safety trials in products that are pharmaceutical equivalents

Bioequivalence • Residue trials? – If the bioequivalence study covers all the time required for depletion (withdrawal), bioequivalence could be a useful tool to avoid unnecessary trials that require animal’s death.

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