(Yicai Global) Dec. 26 -- Generic injectable drugs must go through a therapeutic equivalence assessment, the China Food and Drug Administration said.

This requirement, along with the CFDA's previous one for solid oral preparations, may affect the structure of the pharmaceuticals industry, the 21st Century Business Herald reported.

These evaluations will check the quality, consistency and efficacy of pharmaceuticals.

The scale of China's injectable drug market was CNY757.7 billion (USD115.8 billion) last year, and sales of generics accounted for 72 percent of that figure, per Sinohealth data.

Therapeutic equivalence assessments for oral solid preparations aim to improve quality and effectiveness, whereas the goal of generic injection assessments is solving safety problems, industry insiders said.

Injections, especially intravenous ones, are high-risk medicines and must be strictly regulated, said CFDA Director-General Bi Jingquan.

Almost all generic injections will go through therapeutic equivalence assessments, meaning companies will need to invest in them.

A therapeutic equivalence assessment for oral solid preparations may go for CNY5 million to CNY8 million. Small solid oral pharmaceutical companies' annual profits are often less than CNY5 million and many may withdraw from this market or shut down due to costs.