China's Quality and Therapeutic Equivalence Evaluations of Generic Drugs
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[Tuesday , 20th Sep 2022]
China's Quality and Therapeutic Equivalence Evaluations of Generic Drugs
Grace Wang
BaiPharm
FREE
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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 injectable chemical drugs.

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, generics have more advantages than originator drugs in public medical institutions' volume-based procurements. Thus, generic drugs gradually 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.

Contents

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 having generics with approved equivalence

  • Top 10 generics with approved equivalence

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.