China R&D Reader

On November 30th, China’s MoHRSS (Ministry of Human Resources and Social Security) released the 2009 version of the National Drug Reimbursement List, which includes 260 new drugs, bringing it to a total of 2151 products. In the new list, all 307 members of the Essential Drug List are automatically included in the A class, which [...]

【《财经网》/北京】国家药监局有关分析称，中国药品注册逐渐回归正常，《药品注册管理办法》达到预期目标。
低水平重复申报，曾是中国制药企业新药研发、申报的弊病。2005年，国家药监局批准了11086个药品申请，其中改剂型药1198个，仿制药多达8000多个。为此，国家药监局于2007年发布了新修订的《药品注册管理办法》，力图改进药品审评审批制度，提升药品的准入门槛。
在9月8日的国家药监局新闻发布会上，药品注册司司长张伟表示，从2007年10月1日至2009年6月底，国家药监局共受理药品注册申请4403件。其中，创新药84个，仿制药1682个。同品种申报的比例从2006年的1：6下降为2009年的1：3，“中药已经几乎没有重复申报现象”。
2009年上半年，国家药监局批准新药临床申请173件；批准新药生产申请238件，其中一类新药8件；仿制药申请1074件；进口药申请388件。
张伟认为，药品申报数量大幅减少，申报质量不断提高，申报机构更加趋于理性，药品注册逐渐回归正常，《药品注册管理办法》的实施达到了预期目标。
与此同时，国家药监局还开展了药品研制环节的专项整治工作，以规范药品注册秩序，清除“历史遗留问题”。通过对3.3万个药品开展注册现场核查，撤回了7999个药品注册申请；通过开展药品批准文号清查注销了4337个批准文号；通过开展过渡期品种集中审评处理了2.5万积压品种，其中不批准1.5万个品种。
（《财经》记者 刘京京）

You all know what AstraZeneca CEO David Brennan said last week about big mergers: Not for us; we don’t need it. So what does it need to do to overcome the litany of challenges that face every drugmaker these days? In an interview with The Economist, Brennan says AstraZeneca will cut costs–he doesn’t need a [...]

A workshop held recently in Beijing presented an overview of the current ethical considerations and procedures for effectively designing, conducting and registering clinical trials in China. A key focus was clarifying the working procedures and challenges for ethics committees, also called institutional review boards, in China.
The workshop, called “Ethics in Chinese Clinical Trials: A Roadmap [...]

Merck & Co. has turned to India’s Nicholas Piramal (NPIL) for its latest research collaboration, as the preclinical offshoring trend persists.
NPIL will assist Merck in creating new drugs for two of the pharma giant’s chosen oncology targets, in a deal worth up to $175m (€119m) per target in milestone payments, as well as royalties on [...]

China and India have joined a World Health Organization (WHO)-run international database of clinical trials. Both countries had already recently established their own databases but had to align those registries with a set of standard criteria set forth by a team of experts at the United Nations.
The database was established following an international summit on [...]

French contract research organisation (CRO) Porsolt & Partners Pharmacology has signed a co-marketing deal with Singapore-based start-up Maccine to co-promote their respective preclinical service offerings to pharma and biotech companies.
Maccine has expertise with primate research while Porsolt & Partners specialises in the provision of other animal pharmacology research services.
“We have seen a growing demand for [...]