(Yicai) Dec. 24 -- Chinese regulators have turned down marketing applications for more than 100 generic drugs this month after the country tightened up the approvals process with new draft review standards.

China had rejected marketing applications for 102 generic drugs this month as of Dec. 19, double the number for the whole of last month, and that does not include cases where manufacturers voluntarily withdrew their filings.

The rejected applications span a broad range of therapeutic areas, including drugs for which the market is already crowded with generic alternatives. For instance, more than 60 pharmaceutical companies have already been given marketing approval for amlodipine besylate tablets, a widely used antihypertensive treatment.

"After the CDE clarified the generic drug review standards earlier this month, there has been a considerable number of applications affected by the new rules," Zhou Liyun, chairman of pharmaceutical data services provider PharmaCube, told Yicai.

According to the draft document on generic drug review standards released by the National Medical Products Administration's Center for Drug Evaluation on Dec. 3, regulators will no longer communicate with applicants and will make decisions directly not to approve filings.

Examples of major deficiencies listed in the draft rules include inadequate or insufficient bioequivalence studies, defects in analytical testing, faults in statistical methods, insufficient explanations for protocol deviations during trials, and errors or omissions in application materials.

The tightened review standards are aimed at curbing low-level duplication in generic drug research and development and restricting excessive competition among manufacturers, industry insiders said to Yicai.

"For varieties with extensive competition and many generic drugs already on the market, the value of developing more generics is minimal," Zhou noted. "Regulatory policies should indeed guide the direction of firms' R&D investment to reduce unnecessary waste of industry resources.”

Editors: Tang Shihua, Martin Kadiev