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CPHI China PMEC China CPHI & PMEC Shenzhen

On-demand Webinar

China’s Quality and Therapeutic Equivalence Evaluation of Generic Drugs

Co-organized with BaiPharm

4:00pm-4:40pm CET / 10:00am-10:40am EST

Introduction

Generic drugs account for more than 90% of the marketed drugs in China. In 2012, China initiated the equivalence evaluation plan to require that generics should be equivalent to originator drugs in quality and efficacy. In 2016, China started implementing equivalence evaluation requirements for chemical drugs’ oral solid dosage forms. In 2020, the evaluation expanded to chemical injections.

Quality and therapeutic equivalence evaluation pushes pharmaceutical companies to develop and produce generic drugs of higher quality. If the generics with high levels of quality and efficacy pass the equivalence evaluation, they will be deemed clinical substitutes for originator drugs. With lower prices, the generics have more advantages than originator drugs in public medical institutions’ volume-based procurements. Thus, generics grow to take higher market shares.

This webinar aims to help pharmaceutical companies understand China’s regulatory requirements for quality and therapeutic equivalence evaluation, its market impacts, and the data on accepted and approved applications for the equivalence evaluation.

Speakers

Grace Wang

Regulatory Analyst
BaiPharm

Grace Wang is a regulatory analyst specializing in pharmaceutical regulations and market trends. She provides insights to help international pharma companies with China market access. Her areas of focus include DMF filing, new drug application, pharmacovigilance, and the volume-based procurement policy.

Outline

Regulatory Requirements of Quality and Therapeutic Equivalence Evaluations of Generic Drugs
How Equivalence Evaluation Impacts Pharma Market
Accepted Applications for Equivalence Evaluation
Approved Applications for Equivalence Evaluation