Accelerated the drugs listed multinational drug companies will adjust in the r&d strategy

08:50 March 23, 2017

Source: 39 medicine

Automobil pharmaceutical industry network 】 【 on March 17, the state food and drug supervision and administration bureau released the administration of the state food and drug supervision and administration of imported drug registration management related matters about adjusting decision (draft) "(hereinafter referred to as" draft "). Imported drugs domestically listed hurdles will be broken, for examination and approval of drug approval system for the new breakthrough.

On March 17, the state food and drug supervision and administration bureau released the administration of the state food and drug supervision and administration of imported drug registration management related matters about adjusting decision (draft) "(hereinafter referred to as" draft "). "Draft" requirement, to encourage overseas unlisted new drug approval in the domestic and overseas synchronization to conduct clinical trials, publicly listed company shorten the time interval, and satisfy the public demand for new drugs in clinical, for imported drug registration management related matters will be adjusted as follows:

1. The international multicenter clinical trials in China, cancel the clinical trials should be registered outside the People's Republic of China with medicine or has entered the stage II or III clinical trials, vaccine except drugs.

2. For international multicenter clinical trials in China, after completion of the international multicenter clinical drug trial can be directly put forward listing application for registration of pharmaceuticals, Registration and listing shall be implemented by the drug registration management measures "and other related documents.

3. To apply for import of chemical drugs and drug treatment with biological products innovation, cancellation shall obtain overseas pharmaceutical manufacturers in producing countries or regions listed licensing requirements.

4. Prior to release has been accepted for this decision, in the international multicenter clinical trial data without doing the import registration of clinical trials, in conformity with the requirements, can approve the import.

Is still in draft stage, but once the policy effect, the imported drugs registration management style will change completely change.

In the industry point of view, the New Deal for the most directly related to the multinational drug companies, is a major positive. But there were some voice said: international multicenter trial project of into China, will have an impact on domestic drug firms. To this, the personage inside course of study analysis, imported drugs to speed up the market, will encourage Chinese drug companies from research and development of generic drugs to shift towards the direction of the research and development of new drugs.

Hope medicine to buy! Drug approval efficiency needs to be improved

Imported drugs listed slow problem in China has long been plagued domestic patients, especially some haven't capacity for independent research and development of orphan drugs in our country, is to let the patients hope "medicine".

In China, the orphan drugs research and development of the soil is not fertile. Research and development enterprise and cannot enjoy the extra tax breaks and research and development funding. And the vast majority of abroad research and development of drugs into China, after a series of application for examination and approval procedures, and conducting clinical trials. According to regulations, clinical trials have not less than 200 cases of the samples. And a rare disease, may be can find dozens of cases throughout the country.

Clinical trials for the enterprise, also means that new money spent. At the same time, to complete the drugs introduced a full set of application, examination and approval procedures, it usually takes 5-8 years, is also a long wait for patients.

The director of the state administration of food and drug supervision and administration of jingquan thinks, appear this kind of situation reason is various, the system is on the one hand. In China, points out that the existing clinical trials in China for over a period clinical trials abroad, at the beginning of the second phase of clinical trial, can come to China to apply for.

At the same time, domestic approval personnel shortage, also is the bottleneck of objective existence. China's drug approval time is long, weak. Drug approval center 5000 people in the United States, and only at the end of 2016 to 2016 in our country, although the efficiency has improved than before, but there is still a big gap. Therefore, it is necessary through optimizing process, increase strength, improve the efficiency of the examination and approval step by step.

Available to speed up! Multinational drug companies will adjust in the r&d strategy

State administration of food drug safety has been done in terms of speed up the drugs listed many institutional attempt.

At present, drug marketing authorisation holder system pilot in 10 provinces and cities. Under this mechanism, independent public license and production license. This means that drug research and development institutions can apply for drugs listed independently. After a lot of overseas drug firms and through set up r&d centers in China to speed up the drug approval.

As a deputy to the National People's Congress for medicine, Betta Pharmaceuticals Co., Ltd, chairman of butyl, over the years has been paying attention to the reform of the new drug approval system. He thinks, for any one pharmaceutical enterprises, especially some independent research and development of innovative medicine, every day of time is very precious. Clinical examination and approval of foreign can get approval in about two months, domestic there are a lot of room to improve. He suggested, should be from the system optimization, and decentralization, simplify some procedures; At the same time, improve the approval threshold, reduce declared invalid.

The "draft" clearly pointed out that international multicenter clinical trials in China besides vaccine drugs drugs, cancel the clinical trials should be registered outside the People's Republic of China with medicine or has entered the stage II or III clinical trials. For international multicenter clinical trials in China, after completion of the international multicenter clinical drug trial can be directly put forward listed drug registration.

The personage inside course of study says, after the New Deal execution, through the international multicenter, multinational drug companies listed on the one hand can realize the Chinese market faster registration, on the one hand, can also be true for clinical trials to increase China's global resources.

In addition, the New Deal for multinational drug companies will be an important impact on China's overall development strategy, namely, the easing of policy and clear makes multinational drug companies put China and other markets in the same position. Above the personage inside course of study says, multinational pharmaceutical companies in the global clinical trial before the overall design is rarely consider the Chinese market, because of the slow speed restrictions and more. But now, multinational drug companies should readjust in r&d strategy. Clinical trials in the design and implementation scheme, for example, in the early stages when they sent the reporting requirements of China into consideration.

Many domestic pharmaceutical companies will face elimination

Multinational drug companies to put more clinical trials of new drugs into China, will bring direct benefits, there are two: strengthen domestic clinical research ability, let patients get involved in international new drug clinical trials. But in reality is given priority to with generic drugs, many medicine enterprises in our country will face the fate of elimination.

As is known to all, China's new drug research and development for a long time is given priority to with generics, in clinical trials, drug research and development, talent, technology, and international drug firms is put in bigger difference. In 2015, according to relevant data show that the innovation medicine market nearly $600 billion in the world, about 4 trillion conversion into RMB. But occupy the market in China is less than $10 billion, which is approved for the first time in our country the listed 19 innovative products contribute less than $500 million. China's contribution to the global pharmaceutical innovation is less than 5%.

Most innovative drug market was dominated by foreign drug companies, China's pharmaceutical innovation was only the beginning, pharmaceutical research and development level and abroad is still a gap. And the overseas new drugs to speed up the market, is bound to profound influence on the domestic pharmaceutical enterprises.

Ding minister management consulting co., LTD. In Beijing founder Shi Lichen view, if the new rules into practice, will enhance China's drug firms r&d technology, arouse the enthusiasm of research and development of new drugs. This will encourage Chinese drug companies from research and development of generic drugs to shift towards the direction of the research and development of new drugs, and those without money into local drug firms will be larger impact.

Local drug firms should be how to deal with? In 39 medicine king view, innovation is the core essence, the enterprise to achieve sustainable development innovation certainly won't work. In the future, local drug firms need to do the following two points:

First, innovation, enterprise development thinking, ability of large pharmaceutical companies from generics production flow into the original drug research and development, based on the actual, aimed at the advanced platform for innovative talents and team, further innovative drug r&d investment;

Second, strengthen the internal cooperation and the industry at home and abroad, to encourage internal innovation or capital cooperation, merger and acquisition and so on many kinds of ways, absorb advanced research results at home and abroad, strengthen transformation of industrialization.