CFDA for comments: the review time limit needs to be refined health insurance policy urgently need to be matched

On May 11, the State Administration of Food and Drug Administration issued three drafts for comments on policies to encourage innovation in pharmaceutical medical devices to speed up the review and approval of new drug medical devices (No. 52 of 2017), relevant policies to encourage innovation in pharmaceutical medical devices to reform clinical trial management (No. 53 of 2017), and Policies to encourage innovation in pharmaceutical medical devices to implement the full life cycle management of pharmaceutical medical devices (No. 54 of 2017).
reporter learned that the focus of the current industry discussion is mainly focused on article 53. Article 5 of Article 53 states that "Before conducting clinical trials of Phase I. and III drugs, formal applications and acceptances shall be made after communication between the applicant and the review body." Before carrying out clinical trials of medical devices requiring approval, formal applications and acceptances must be made after communication between the applicant and the review body. After 60 working days from the date of acceptance, the review body shall be deemed to have agreed without giving a negative or challenged examination opinion, and the applicant may conduct clinical trials in accordance with the proposed scheme. Seven good official landing
said an industry authority expert who did not want to be named, 52, 53, 54 text brought a lot of good information, including six good news if officially landed, will further improve China's current drug innovation environment. Article 2 of Article 52 states support for the development of drugs and medical devices for the treatment of rare diseases. The Department of Health and Family Planning publishes a catalogue of rare diseases and establishes a registration system for patients with rare diseases. Applicants for rare disease treatment drugs and medical devices may apply for waiver of clinical trials to expedite the review and approval of medical devices for rare diseases. For foreign approved rare disease treatment drugs and medical devices, can be conditions approved for listing, after the listing within a specified time to do the relevant research.
Article 6 of Article 52 of the National Law, medical institutions are encouraged to give priority to the procurement and use of new drugs with clear efficacy and reasonable prices. Research and improve the dynamic adjustment mechanism of medical insurance drug catalogue, explore the establishment of medical insurance drug payment standard negotiation system, and support innovative drugs to be included in the scope of basic medical insurance payment according to regulations. According to the needs of disease prevention and control, local organizations in the provinces (autonomous regions, municipalities directly under the Central Government) as a unit of centralized procurement.
the industry's long-awaited clinical trial institutions "qualification" to "filing management." Article 1 of Article 53 states that clinical trial institutions are disqualed. Medical institutions with clinical trial conditions may accept the applicant's commission to conduct clinical trials after registering on the designated website of the food and drug regulatory department. Encourage social capital to invest in the establishment of clinical trial institutions to provide clinical trial professional services. The main researchers in clinical trials must have senior professional title and have participated in more than 3 clinical trials. Clinical trial applicants may engage a third party to assess and certify the qualifications of the clinical trial institution.
the question of the interoperability of clinical data at or outside China, the answer is given in Article 6 of Article 53. If the clinical trial data obtained by the applicant abroad meet the relevant requirements for the registration of pharmaceutical medical devices in China, they can be used to declare the registration application in China after on-site examination. If an international multi-center drug clinical trial conducted by an overseas enterprise in China meets the relevant requirements for drug registration in China, it may directly apply for listing after completing the international multi-center clinical trial. For medical devices that are first listed in China, applicants should provide clinical trial data that do not differ racially. If the bioethic equivalent test data of the applicant approved for listing generic drugs in the European Medicines Administration, the United States and Japan meet the relevant requirements for drug registration in China, they can be used to declare the registration of generic drugs in China after on-site examination. The clinical trial data submitted by the applicant upon approval for listing abroad may be used as clinical trial data for the registration of medical devices in China, except for the third type of medical device that requires clinical trial approval.Many experts in the
industry believe that the greatest advantages of the release of Article 54 are two: First, Article 1 proposes to summarize the pilot experience of drug market licensing holders, combined with the revision of the Drug Administration Law of the People's Republic of China, the system of listed license holders will be widely implemented among drug and medical device licensing (registration) people nationwide;More thanquestions remain to be answered
At the "Future Leaders Summit of China's Pharmaceutical Industry" on May 12th, participants also noted that there are measures to speed up the development of new drugs into clinical trials in the consultation document. For example, can a clinical trial application for an original innovative drug eliminate full on-site verification by the provincial bureau on the basis of "risk-based regulation"? Or specify the different requirements for on-site verification of clinical trial applications (INDs) and new drug product applications (DAs) and provide clear timelines to avoid additional filing times that can sometimes last up to several months.
, many industry experts have also raised questions about the new practice of "convening meetings of review bodies". In their view, according to the current technical level of china's drug review and the number of personnel, the time limit for convening a review body meeting is difficult to determine. The original innovation drug review and approval is mainly "card" in the review and approval slow problem, how to ensure that the time limit for convening the review body meeting needs to be further clarified, otherwise it is difficult to fundamentally solve the problem of slow review and approval of innovative drug.
data on "Global Innovative Drugs 2010-2016" given by Yu Kun, Director of Market Access at Gilead Scientific Central Government, show that there are three main characteristics of innovative drug research and development: longer cycles, greater investment and higher risk. In 2016, three-and-a-four of the world's new chemical structure drugs were first approved by the FDA, with the European Union, Japan and other countries and regions catching up quickly, but China is still zero.The release of the
" three drafts does inject new vitality into China's new drug review and approval, but a number of policies, such as health care, urgently need to keep pace with the pace of reform, in order to attract more multinational companies to bring new products to China for registration and declaration. Yu Kun believes that China should open up reimbursement ratios for different categories of drugs according to the severity of the disease: the more serious the disease, the higher the reimbursement ratio, such as drugs for cancer and AIDS. At the same time, according to the drug ASMR rating, the better the ASMR rating, the higher the reimbursement ratio.
, Yu suggested that China could learn from the experience of Japan and Taiwan on the pricing of new drugs. First, similar to the drug effect comparison method. Newly marketed drugs are compared with similar drugs already on the market, combined with the innovative pricing of pharmaceuticals. Second, the cost pricing method. For listed drugs that cannot be compared with existing drugs, reasonable profits and expenses are added through production costs. Third, the price method. On the basis of calculating the price of new drugs according to the above method, the price coefficient between the international average price and specification is adjusted.Sysm>>>Asason Pharmaceuticals Chairman and CEO Dr. Yang Dajun:
" this time issued three documents, which encourage drug research and development more than we think, policy-making and international standards are obvious.
company's top concern is the Policy on Encouraging Drug Medical Device Innovation and Reforming Clinical Trial Management (Draft for Comments). Article 1 of its documents changes the qualification of clinical trial institutions to filing management. This is the basis of innovative drug research and development of pharmaceutical companies, clinical trial reform without the support of clinical institutions can not be done. Now to the record, the qualifications of researchers have been stipulated, the drug supervision department to carry out on-site inspection and disclosure, in a certain mechanism to ensure openness and transparency.
, it is important to emphasize the responsibilities of the bid. Whether a clinical trial institution is qualified, companies can do so by hiring a third party, or by hiring a third party, or if they are qualified, they can do so themselves. The industry will be worried about whether clinical trial institutions will be in a state of disarray without regulation if they are filed, so it is important to clarify the responsibilities of the bidders.
, of course, in our view, the biggest impact is the "optimization of clinical trial review procedures" provision. It provides that after 60 working days from the date of acceptance, the review body does not give a negative or challenged examination opinion is deemed to be consent, the applicant may carry out clinical trials in accordance with the submitted program.
this initiative and international regulations, is conducive to the orderly progress of research and development, without waiting too long and miss opportunities.
and in accepting data from overseas clinical trials, we are also looking forward to the landing of the official document. As an innovative pharmaceutical company with very close international cooperation, it is an international practice to accept data from overseas clinical trials where there are no racial differences. On the one hand, to ensure the rights and interests of patients, on the other hand, it is also conducive to enterprises to carry out international strategic cooperation, improve research and development and product launch efficiency, improve competitive advantage in international competition. Reding pharmaceutical related person in charge said:
" last night, the State Bureau of the three drafts on encouraging drug innovation, our company is very concerned, clearly feel the General Administration to speed up the clinically urgent need for the review and approval of new drug medical devices reform of firm determination and practical measures, for all serious drug enterprises are a major advantage. Of course, some of the reforms may involve more authorities than the CFDA, and may require a higher level of coordination.
The relevant policy on encouraging innovation in pharmaceutical medical devices to speed up the review and approval of new drug medical devices on the market mentions that in accelerating the clinically urgently needed products, the encouragement measures are very strong and will guide enterprises to adjust their research and development strategies and directions, pay more attention to clinical needs to develop products, not just to make a new compound.
reform measures, which focus on independent research and development and cooperative development, will enable us to face international competition and cooperation more directly, with opportunities and challenges coexisting. We will pay more attention to China's clinical needs, for the domestic clinical urgent need to develop new drugs, such as platinum sensitive relapse ovarian cancer maintenance treatment, there is no effective treatment drugs. (Medical Economics)