Medical network - May 15, May 11, sending 3 draft to the CFDA, respectively "about to encourage pharmaceutical medical equipment innovation to speed up the new medical equipment listed for examination and approval of the review of relevant policy" medical device innovation reform about encouraging drug clinical trial management related policy "and" about medical equipment innovation encourage drugs drugs in whole life cycle of medical equipment management policy ". 

 

The three policy, show the CFDA nearly two years in the solution of the state council to speed up the drug approval listed medical device review related problems on how to further deepen the review for examination and approval system reform, promote the pharmaceutical medical equipment industry structure adjustment and technology innovation, enhance the competitiveness of industry, to meet clinical needs a new direction, the public means of pharmaceutical management of medical equipment is going to enter the new era total life cycle management. 

 

Drug article 

 

The review rule is clear again! 

 

Good clinical needs, rare diseases, international medicines 

 

First, two types of drugs are not marketed in advance 

 

To speed up the innovation medicine for examination and approval of the review, in the "about medical equipment innovation to speed up the new medical devices encourage drugs listed for examination and approval of the review of relevant policy" explicitly mentioned two kinds of drugs can be conditional relief clinical listed in advance: one is to treat severe life-threatening disease and there is no effective treatment of medicine medical apparatus and instruments, and other solutions are of great significance to the clinical requirement of medicine medical apparatus and instruments, early and mid-term clinical trials indicators curative effect and can predict the clinical value of; Second, the rare medical treatment drugs and medical devices that have been approved by foreign countries. Although the above drug can obtain the treatment of early public offering, but the research content that still wants to undertake according to the requirement according to the requirement, benefit more is to go public time. 

 

For the ongoing clinical trials for the treatment of severe life-threatening disease and there is no effective treatment of medical apparatus and instruments, in the medical device innovation reform about encouraging drug clinical trial management related policy "was allowed to support development in clinical trials, namely the drug primary observation may benefit by the clinical trials, and meet the requirements of the ethics, the informed consent can be used for other patients, after its safety data can be used to support review of the examination and approval. This provision once again ensures the feasibility of early listing of such drugs from the process. However, to expand the use of the use of the test drug is limited, only in conducting Ⅱ, Ⅲ period clinical trial institution to use, and use the number of clinical trials may not exceed the stipulated number of subjects. 

 

Strong copy can be given priority review 

 

Two types of drugs are mentioned allowing priority review and approval: 

 

One is included in the national science and technology major projects and national key research and development plans to support innovative drugs and medical devices, this one was in February 2016, the "administration about addressing drug registration for priority review backlog of examination and approval opinions" priority review mentioned range of examination and approval of one of the seven items. 

 

Secondly, the major threat to public security situation, is a new, "according to the relevant provisions of the patent law of the People's Republic of China, to protect public health, in public safety threatened by major cases, the applicant may apply for compulsory license to the intellectual property department, the intellectual property department decided to implement the drug patent compulsory license, drug approval agency to get the registration priority review compulsory licensing examination and approval." The situation of public safety and the process of starting compulsory license are specified by the ministry of health and family planning, which provides the legal basis for "strong copy". 

 

The dosage form is strictly controlled 

 

Improved medicine aspect, in November 2015, the state food and drug supervision and management of the administration of drug registration for examination and approval of the review several policy announcement "modified type specification mentioned when review of examination and approval of new drugs," to change the original drug dosage forms, acid radical, such as the base and method for drug registration, the applicant to prove its technological innovation and has obvious advantages in clinical value compared with the original varieties; cannot prove that has these advantages, shall not be approved. Changing types and specifications of children except for drug registration ". The 2017 consultation will be in line with the clinical treatment guidelines requested by the NHFPC, which will give priority to oral preparations and strictly control the approval of the injection. This will change the scale of the current clinical terminal injection from the supply side of the product. 

 

The products are expected to be free of clinical use 

 

After the approval of data from overseas clinical trials, the applicant will reduce some clinical trials and speed up the examination and approval. Draft that meet the requirements of the relevant Chinese medicine medical device registration, after site inspection can be used in the Chinese filing an application for registration of clinical trial data with 4 categories: 1) the applicant in the clinical trial data sources outside; 2) clinical trial data of international multicenter clinical trials conducted by overseas enterprises in the international multi-center clinical trials in China; 3) the data on the biometric equivalent of approved generic drugs in the European drug administration, the United States and Japan; 4) the applicant approed for sale in foreign medical apparatus and instruments, in addition to the need for clinical trials to the approval of the third class medical apparatus and instruments, outside submitted when an approed for clinical trial data. 

 

Data can be directly used in clinical trials in China, according to the registered public good in the short term in two types of products: one is already listed drug administration in Europe, America and Japan were allowed to generic drugs of domestic enterprises, or has imported generic drug company of real estate in our country, the factory is expected to be free of clinical approved listed and approved by the qualification of consistency evaluation; Second, new drugs are being listed in China. 

 

The classification of traditional Chinese medicine is subject to adjustment 

 

From the draft, the reform of the CFDA chemical-based medicine gradually extended to the traditional Chinese medicine (TCM) : "innovation kind of traditional Chinese medicine (TCM), in accordance with the" new curative effect "on the assessment standard for examination and approval; modified form, of new drug of TCM should be able to reflect the clinical applications of advantage; classic square kind of traditional Chinese medicine, according to the simplified criteria for examination and approval of the review; natural medicines, according to modern medicine standard review approval". This means that the classification of traditional Chinese medicine is also likely to be rearranged like a drug. 

 

The listed injection will be reevaluated 

 

In the case of the listed drugs, the consensus evaluation of the generic pill will continue, and the main target is the injection. "According to the injection drug scientific progress, has approved the injection to evaluate safety, efficacy and quality controllable. Production enterprise shall be approved at the time of the study situation, post-marketing follow-up research and so on carries on the comprehensive analysis of research on product composition, mechanism and clinical trials, and to evaluate its security, effectiveness and quality control. Strive to use 5 ~ 10 years was basically completed injection again already on the market evaluation. Through evaluation again, enjoy chemical generics oral solid preparation quality and curative effect evaluation of relevant policy consistency". 

 

It is estimated that the three types of safety risk, such as injection of chemical injection, Chinese medicine injection and multi-component biochemical injection, are the most affected. Medical devices, too, face re-evaluation. 

 

Clinical organization 

 

The clinical establishment is no longer a rumor! 

 

Will the cost of the trial be drastically reduced? 

 

Release have been rumors of clinical institutions, medical device innovation reform about encouraging drug clinical trial management policy "has been clear about the clinical trial institution qualification instead of filing management. 

 

Preparation management means that the number of clinical trial institutions can be increased, and the cost of clinical trials is expected to return to reasonable market competition. Cost of clinical trials, however, is not only the cost of agency, also includes the rest of the cost, according to the present compliance development direction, the fees is difficult to drop dramatically. Given this, companies tend to choose clinical institutions that have good records in the past. 

 

Clinical trials for the reform of the management, mainly for the process details, especially for the perfection of mechanism of ethics committee, to enhance the efficiency of ethical review, ethical review platform construction, the reform of the drug clinical trial sample test system, etc. 

 

Compliance, 

 

Detail concrete! 

 

Legal compliance requirements for academic promotion 

 

Guangzhou, nanjing occurred more than a medical representative recently, much attention has been paid to arrest event industry especially confused on the future direction of medical representatives "about medical equipment innovation encourage drugs drugs in whole life cycle of medical equipment management policy" will be the promotion plan included in the total life cycle management category. 

 

The medical representative will be responsible for the academic promotion of new drugs, introduce the knowledge of new drugs to clinicians, and listen to the clinical use of new drugs. Medical representatives are forbidden to take drug sales task, banning private contact with doctors, medical representatives to ban anyone to a medical representative of medical institutions, pharmaceutical production management enterprise to provide the individual doctor prescribe medicines. 

 

The system will execute medical representatives: marketing authorisation holder (pharmaceutical production enterprise) should be a medical representative list the site specified in the food and drug regulator for the record, to the public. Where a pharmaceutical business is conducted in the name of a pharmaceutical representative in the name of a medical representative, the relevant departments shall, in the name of the medical representative, be concerned with the illegal handling of the drugs. 

 

Medical representatives in medical institutions should make public the academic promotion activities and file the records in the designated department of medical institutions. 

 

These aspects of innovation, carry out marketing activities for academic means that pharmaceutical companies in the future will be more and more compliance, related costs will be more and more transparent, artificially high price of drugs bill legal risk will increase. 

 

The review system of medical devices for medicines also requires compliance. On the one hand, the examinators are forbidden to communicate with the applicant. On the other hand, the evaluation process of the project should be established to communicate the communication system with the applicant, so that the applicant can have the opportunity to communicate with the examinators in public. During the review period, the applicant may request to arrange the meeting. New drug Ⅰ period clinical trial before the declaration after the clinical trials, Ⅱ Ⅲ period before the start of clinical trials, and Ⅲ before declaring production listed after the stage of clinical trials, the three important node, the applicant and review member meeting must be fully discussed. This fully demonstrates that the communication and communication of legitimate and reasonable compliance is permitted and encouraged. 

 

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The three policies will affect the development of the pharmaceutical industry at different levels. Clinical demand, rare diseases, internationalization is consistently positive direction, drug supply side reform injection and clinical trial institution change is a new bright spot of access. Full compliance will be no longer a requirement for the internal management of import companies, but a new subject that the entire industry must cope with.