On June 20, 2017, May 31, 2017, the international medical registration technology coordinator (ICH) will hold its first meeting in Montreal, Canada, on June 1, 2017.
The meeting passed the application of the state administration of food and drug administration, which became an official member of the international medical registration technology coordination committee.
▍ : why do you want to join, for example? What is the point?
ICH since its inception, has been gradually developed into the most core in the field of drug registration mechanism of technical rules, us, Europe and Japan drug regulatory departments shall, in accordance with the technical guide for the review, for example, the rest of the world drug regulators are accepted in whole or in part based on the example technical guide to carry out the review.
Join administration of ICH is actively implement the "four most strict" requirements of "the most rigorous standards" major step, is also the international community recognition and support of China's ongoing reform the important embodiment of for examination and approval of drug approval.
Join administration of ICH is conducive to draw lessons from the international latest regulatory science achievements, absorb advanced international regulatory concept, and promote our country's drug regulatory ability and level, gradually to participate in and guide the formulation of international rules, strengthening the voice in international organizations;
To join, for example to encourage international innovative pharmaceutical enterprises will be the Chinese market into its global drug development strategy, promoting international innovation drugs into China, meet the demand of clinical drug use.
Join ICH will be conducive to the Chinese medicine research and development and registered with the international rules, step by step to improve China's pharmaceutical industry innovation capacity and international competitiveness.
▍ join ICH mean that international recognition? What impact will this have on our pharmaceutical industry?
The United States, the European Union and Japan has a mature and perfect drug regulatory system and the pharmaceutical industry, dominated by the ICH coordinated worldwide for a long time about the drug quality, safety and efficacy of technical specifications, promote drug registration technical requirements of the rationalization and consistent, has become a top rules of the international drug registration technology mechanism. These standards are universally applicable in developed countries and are widely accepted in developing countries, including China. Some of the drugs are poorly regulated and even accept or recognize the results of the ICH membership.
China's state food and drug supervision and management of administration to join, for example, marked the international community to the reform of the Chinese government for examination and approval of drug approval and recognition of Chinese medicine industry, means that the international community is willing to accept Chinese regulators, the pharmaceutical industry and research institutions to join the highest international rules and standards setting process. This has a positive and positive impact on our regulatory system and the international recognition of the pharmaceutical industry.
But at the same time we must also see clearly that, after joining example also need our further and long term hard work, in the process, not only needs the government in the implementation of technical guidelines into and a lot of work, also need to industry, academia, make unremitting efforts in executing these guidelines.
▍ at present, for example technical guidelines in the application status of drug registration in China? What's next?
ICH built a regulator with industry to discuss drug registration of scientific and technical issues of the international platform, its technical guidelines has become a general drug registration on behalf of the international advanced level of technical requirements. Currently, ICH has published 76 technical guidelines.
We always pay close attention to and research, for example technical guidelines, administration organization in recent years make many technical guidelines issued by the reference in different degrees in the process of drafting the ICH related guidelines, with, for example on the content and technical requirements technical guidelines very close.
On August 5, 2016, administration of human medicinal center on the reference use of the WHO, ICH guide drug development technologies such as notice, clear of drug research and development institutions may refer to the world health organization (WHO), international people with drug registration technical requirements to coordinate (for example), the United States food and drug administration (FDA) and European drug regulatory agency (EMA), release all kinds of technical guidelines for drug development.
Next, the administration will actively participate in ICH related work, more Chinese sound in the world, at the same time will further promote the ICH technology transformation and implementation of the guiding principle in domestic.
▍ after China officially became a member of, for example, for Chinese enterprises in drug development and drug registration internationalization will meet what are the opportunities and challenges?
ICH's main job is to make people use drug registration of international technical requirements, after China's entry into, for example, can participate in the process of making the ICH guidelines, at the same time also need to gradually in the domestic implementation of ICH guidelines, this means that the Chinese drug registration technical requirements in line with international standards of the road has been fully open, drug research and development and the registration has entered the era of globalization.
Realizing the coordinated, consistent, and drug registration technical requirements to carry out the international registration of the pharmaceutical companies, will be in the same technical requirements to multiple national or regional regulatory filing, greatly save the cost of research and development and registration. It could lead to new drugs to enter the Chinese market, foreign production also is advantageous to the international market, China's products to promote more and more Chinese enterprises to join international registration.
By implementing ICH guidelines, will deepen China's pharmaceutical enterprises in drug registration of international understanding of technical requirements, the r&d work little detours, improve the success rate of international registration.
But the addition of ICH means that China's pharmaceutical industry will compete in the global landscape. The pharmaceutical industry in our country has a wide gap with the developed countries, such as Europe, the United States and Japan, especially in the capacity of innovation and development. Domestic companies to seize the opportunity, actively study and understanding of ICH guidelines, and blend in these technical requirements to the enterprise product research and development, registration, and the production of each link, really into their own rules, to improve the quality of product safety, improve the core competitiveness.
ICH is regulators with the participation of the pharmaceutical industry, non-governmental international organization, is the regulators and industry to discuss the exchange, mutual promoting development, finally reached a consensus process. As regulators, I also need to further enhance the regulatory capacity, improve service levels, strengthen policy guidance, work together with industry, to safeguard and promote public health, improve the accessibility of drugs continue to work hard.
▍ after China officially became a member of, for example, the speed of global innovation drugs approved in China will have what kind of?
In August 2015, the state council issued the opinions about drug review of medical equipment examination and approval system reform "(guo fa [2015] 44), marked the YaoXie review for examination and approval system reform started in an all-round way. After more than a year of time, I in improving drug approval standards, encouraging drug research and development innovation, improve the efficiency of review for examination and approval, standardize clinical trials take series of measures, actively yet prudently proceed with work of reform.
Among them, in order to speed up with clinical value of new drugs and urgent clinical needs of generic drugs, meet the demand of the public administration, implemented priority review policy of examination and approval, has significant clinical value, 17 kinds of situations, the three categories of drug registration application for priority review for approval. Priority review policy has obtained the good effect of examination and approval, in 2016, antitumor drug GeFei, slice, pei azole panitan pieces the treatment, pieces and a number of public expects drug approval successively by priority review into the market.
The rapid growth of the China's huge market capacity of pharmaceutical products and drug approval for examination and approval system reform policy of dividend showing, attractive to pharmaceutical companies is self-evident. Technical requirements after China's entry into, for example, with the international differences will shrink or even disappear, Chinese enterprises in the innovation medicine development to include them in the path of the global development plan will be more smooth, will further improve the enthusiasm of innovative drug r&d in China and registered, and can be expected, in the near future, there will be more innovative drug on the market in China, to better meet the demand of the public administration. |
