China\’s Quality and Therapeutic Equivalence Evaluations of Generic Drugs

Background

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 evaluations expanded to chemical injections.Quality and therapeutic equivalence evaluations push pharmaceutical companies to develop and produce generic drugs of higher quality. If the generics with high levels of quality and efficacy pass equivalence evaluations, 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 the quality and therapeutic equivalence evaluation, its market impacts, and the data on accepted and approved applications for equivalence evaluations.

1. Regulatory Requirements of Quality and Therapeutic Equivalence Evaluations of Generic Drugs

1.1 The equivalence evaluation\’s aim, application scope, research contents, and time limits

1.2 The equivalence evaluation\’s procedure and timeline

1.3 How to select a reference listed drug

1.4 Bioequivalence study and clinical efficacy trial

1.5 Drugs deemed to pass the equivalence evaluation

2. How Equivalence Evaluations Impact Pharma Market

2.1 R&D: improving generic drugs\’ quality

2.2 Market share: lower share for originator drugs, higher share for generics

2.3 Procurement: volume-based procurement at low prices

2.4 Social healthcare insurance: less pressure on the healthcare insurance fund

2.5 Payment: diagnosis-related group (DRG) reimbursement

3. Data on Equivalence Evaluations

3.1 Accepted applications for equivalence evaluations

Total of the accepted applications
Shares of different dosage forms

3.2 Approved applications for equivalence evaluations

Total of the approved applications
Top 10 companies with approved equivalence evaluation applications
Top 10 generics with approved equivalence

Schedule

Date	Time (GMT +8)	World Clock	Language
2022-09-20	21:00 ~ 22:00	London: 13:00-14:00 New York: 9:00-10:00	English

Speakers

Grace Wang

ChemLinked Regulatory Analyst

Grace Wang is a regulatory analyst and editor specializing in pharmaceutical regulations and market trends. She provides news and 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.

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