The Chinese generics industry is undergoing greater scrutiny, as the country focuses on improvements for the new year. Generics evaluation, in particular, is under pressure to implement newly established requirements. Among these are new regulations for biogenerics equivalence testing. Previously, the SFDA (China’s FDA equivalent) regulated biogenerics in line with small-molecule generics. But under more recent provisions, they will be regulated as new drugs. Experts predict that the new system will have a direct impact on pricing, bidding and reimbursements.
Biogenerics Equivalence Testing in China
What is referred to as a generic drug varies from country to country according to regulatory requirements. Although a system for bioequivalence evaluation of generics has been in place in most countries for over 20 years, international standards are still evolving. China’s dominant role in generics manufacturing has been challenged by weaknesses in the system, and the government is under a self-imposed time constraint to make changes.
A recent government report points to several existing problems within the Chinese system, from a lengthy registration process to a lack of pricing and bidding incentives (i.e. about 60% of pharmaceuticals sales in China are regulated). In response to these issues, the Chinese government recently announced intentions to speed up the drug registration process.
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