The drug cosmetics registration division: accept overseas clinical trial data listed efficiency

Administration of state food and drug supervision and administration of today ( On October 9) Held a press conference to introduce drug review of medical equipment examination and approval reform encourage innovation work, interpretation of the relevant documents. Was asked: 'about deepening the review for examination and approval system reform to encourage drug's opinions on the innovation of the medical apparatus and instruments offered to accept outside of clinical trial data, the data include what? The significance of this to encourage innovation what directly? Pharmaceuticals, cosmetics manufacturer, director-general of the department of registration Wang Lifeng answered and said to them, in innovative ideas, and put forward the multi-center clinical institutions overseas clinical trial data, to meet the requirements of drug registration in China, can be used to declare registration in our country. Purpose is to reduce the repeated trials, reduce development costs, improve the efficiency of the public, some new drugs into our country listed abroad there is a delay period, in order to shorten the delay time, improve the availability of drugs, in China, we put forward such a measure. This is also an international practice. In the past we asked to our listing of drug clinical trials must be carried out in our country, its purpose is to ensure the safety of these medicinal on Chinese can effectively. The proposed accept overseas clinical trial data is conditional, first of all should conform to the requirements of the registration related in our country, at the same time should also prove that there is no racial difference, because westerners and easterners in medicine have some differences, so you need to avoid this kind of difference. Was acceptable, on the other hand, must have the conditions, to provide a safe and effective in Chinese some of the data. Synchronization for international multicenter clinical trial in our country, is this a project in China already do, also do in a foreign country. Accept overseas clinical data not only is advantageous to the foreign enterprise, but also to domestic innovative companies, this is a win-win situation. Walked out of the abroad, there were a number of innovative enterprises abroad, especially in the United States, Japan, the European Union to carry out the drug registration, they registered abroad, clinical trial data can also be used for drug registration in our country, so it can reduce duplication of clinical trials, improve efficiency, reduce development cost, also can reduce the period of some foreign medicines on the market in China. We will perfect the guiding principle of clinical trial data management, thinning, clear what is acceptable and what is not acceptable, so everyone can see it clearly. At the same time, to strengthen the supervision and examination of the clinical trials, is not only to accept, and they sent inspectors to the overseas clinical trial institution to do so. Through the establishment of overseas examination mechanism of clinical trials, and gradually stepped outside of clinical trials of inspections and ensure the clinical trial data accurately. Clinical trials to entrust agreement and clinical trials researchers is the first responsibility of the clinical trial data, the reliability of the clinical trials need to assume legal responsibility.
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