CPhI & BaiPharm Event: Generic Drug Application Procedures in China

by Grace Wang Jun 21, 2022

On June 22, BaiPharm is going to co-organize a webinar with CPhI China on the topic of Generic Drug Application Procedures in China.

Time: 3:00pm ~ 4:00pm, 22 June 2022 (UTC+8 China Time)

Language: English

Registration link: https://www.pharmasources.com/vec2022/program/detail/82

Background

China has become a powerhouse that manufactures and imports generic drugs. These years, China Center for Drug Evaluation (CDE) has approved substantial abbreviated new drug applications (ANDA) for generics.

In 2021, CDE completed reviewing 1,791 chemical ANDAs, accounting for 19.4% of all the 9,231 drug applications that entailed technical review.

In China, the competition is spiraling up for generics as the drug regulators mandate consistency evaluation for generic products and slash prices through negotiation for volume-based procurement (VBP). Nevertheless, the Chinese market still has huge potential for generic drug products, especially for generics that overcome technical barriers.

Contents

In this webinar, we will introduce how to apply for generic drug registration in China and answer the following questions:

  • What are the definitions and registration classifications of generics in China?

  • How are RLDs regulated and how the RLD choice affects the ANDA pathway?

  • What is the main requirements for Quality and Therapeutic Equivalence in China?

  • Will overseas clinical/bioequivalence (BE) data be accepted by China CDE?

  • What is the key point in China to prepare ANDA dossier?

  • The timeline and registration fee for ANDA.

Speaker

L. Xia, Master of Pharmaceutical Chemistry and Technology (CTF), University of Milan

Ms. Xia has a deep understanding of the regulations on pharmaceutical products, APIs and excipients in China and Europe. She once worked in Industriale Chimica SRL and Flamma Spa in Italy for years and joined a Chinese pharmaceutical company Zhejiang Hengkang Pharmaceutical Co., Ltd. as RA manager in 2016. With her extensive experience on both RA and QA positions, she is familiar with submitting registration applications for domestic and imported finished drug products, APIs, and pharmaceutical excipients to China NMPA, and CEP applications to EDQM, etc.

CPhI & P-MEC China

CPhI & P-MEC China is Asia's premier pharmaceutical event. It offers an alternative for global pharma professionals to boost business online, adding valued services and infinite opportunities to connect, source, learn, trade and grow.

Register to Attend the Event

Grace Wang
ChemLinked Regulatory Analyst
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