On June 20, the state administration of food and drug administration convened an "ICH news conference". On May 31, 2017, "the international medical registration technology coordinator (ICH) will meet for the first time in 2017" in Montreal, Canada, according to the press conference. The meeting passed the application of the state food and drug administration, and formally approved the administration as its member. On June 14, upon the approval of the state council, the director of the state administration of food and drug supervision and administration, for example management committee chairman Dr Mullin jingquan writing, administration of official confirmation to join, for example, become a member of the eighth regulators around the world.
Meetings, the state drug supervision administration, director-general of the department of international cooperation Yuan Lin said the administration to join ICH will help promote our country's drug regulatory ability, gradually participate in and guide the development of international rules for drug registration, encourage innovation in the safe and effective drugs meet the demand of clinical medicine at home and abroad at an early date. At the same time, also means that China's drug regulators, the pharmaceutical industry and r&d institutions will gradually convert and implement the highest international standards and guidelines, can effectively increase the domestic pharmaceutical industry innovation capacity and international competitiveness.
Yuan Lin is introduced, 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.
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.
It is understood that in November 2014, the general administration of China expressed its willingness to join in the ICH Lisbon conference. In March 2017, the general administration formally put forward a request for membership. At 9:30 a.m. on June 1, Geneva, the first meeting of the ichq in 2017 was held behind closed doors, with a warm applause for the general administration's approval. After three years of hard work, China's food and drug regulation is on the international stage with an increasingly high profile.
For example in 1990 by the United States, the European Union and Japan joint by drug regulatory departments and industry associations, the reform started in 2012, and eventually in December 2015, by a closed international conference mechanism, into a technical non-governmental international organization registered in Switzerland under the civil law. ICH is the basic principle of coordination in the field of drug registration technology and the establishment of international technology on drug safety, effective and quality standards and norms, as the basis of regulators approve drugs listed, thus reducing drug research and development and listing costs, promote the innovation of safe and effective drug for patients at an early date health services. After 20 years of development, for example technical guidelines have been released to the world's major national drug regulators accept and transformation, has become one of the core mechanism of international rules in the field of drug registration.
At present, what is the current status of ICH technology guidelines in our country's drug registration? What's next?
Yuan Lin points out, for example built a regulator with industry to discuss drug registration of scientific and technical problems 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.
What are the opportunities and challenges for Chinese companies in the development of pharmaceutical r&d and drug registration?
State drug supervision administration drug registration department deputy director li fang said, for example the 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.
What will be the speed with which global innovation drugs will be approved in China after China becomes a member of the ICH?
Yuan Lin, said in August 2015, the state council issued by the drug review of medical equipment examination and approval system on the reform of opinion "(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. |
