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CFDA bursts of four new medical examination and approval, clinical trials such as large open

CFDA bursts of four new medical examination and approval, clinical trials such as large open

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[Abstract]:
In May 11th, the State Administration of food and Drug Administration issued a total of four major reform policies (Draft), for public opinion.
Respectively:
1. Relevant policies on encouraging the in

In May 11th, the State Administration of food and Drug Administration issued a total of four major reform policies (Draft), for public opinion.

 

Respectively:

 

1. Relevant policies on encouraging the innovation of pharmaceutical and medical devices and implementing the lifecycle management of pharmaceutical and medical devices (Draft for comment);

 

2. Relevant policies on encouraging the innovation of pharmaceutical and medical devices and protecting the rights and interests of innovators (draft);

 

3. Relevant policies on encouraging the reform of clinical trials of drugs and medical devices innovation (Draft for comment);

 

4, the relevant policies on encouraging the innovation of pharmaceutical and medical devices, speeding up the review and approval of new medical device listing (draft).

 

Four "the draft" refers to the same goal: to encourage innovative drugs and medical devices.

The administration's hand considerable efforts, innovation is expected to usher in a major positive domestic yixie. Among them, there are a number of important initiatives, including:

 

1, large opening of clinical trial institutions

Qualification of clinical trial institution changed to record management. Cancellation of accreditation of clinical trial institutions. The medical institutions with clinical trial conditions can be accepted by the applicants for clinical trials after registration and registration on the designated websites of the food and Drug Administration departments. Encourage social capital investment to set up clinical trial institutions and provide professional services for clinical trials."

 

Large opening of clinical trial institutions is expected to break through the existing bottlenecks. But at the same time, after the record management, clinical test data inspection work will be strengthened, in order to maintain authenticity, put an end to fraud.

 

2, hospitals and doctors participate in clinical trials big release

"Support medical institutions, medical research institutions, medical colleges and universities to participate in clinical trials, the conditions and ability of clinical trials into medical institutions grade evaluation, important indicators of clinical key disciplines identified. To encourage three grade a medical institutions, provincial and higher undergraduate medical colleges affiliated hospital to undertake clinical trials. Encourage medical institutions to set up full-time clinical trials departments, equipped with professional clinical trial personnel. Encourage clinicians to participate in drug and medical device technology innovation activities. Medical staff who carry out clinical trials are equally treated with clinicians in terms of job promotion and Title promotion. To improve the income level of clinical trial researchers by improving the incentive mechanism of distribution of performance pay."

 

3. Release of clinical trial review procedure

Before carrying out the clinical trial of medical devices which need to be examined and approved, the applicant should be formally applied and accepted after the meeting of the applicant and the review institution. 60 working days after the inspection organ from the date of acceptance, not to give negative or question review comments deemed to carry out clinical trials, the applicant may submit the plan in accordance with the."

 

Without approval, the approval of clinical trials is expected to speed up again.

 

4, domestic clinical trial data liberalization

"Receiving clinical trial data abroad". The clinical trial data obtained by the applicant in line with the relevant requirements of the Chinese drug and medical device registration can be applied for the registration application in China after on-site inspection. The applicant in the overseas listing of medical devices, in addition to the third types of medical equipment clinical trial approval, clinical trial data submitted in the overseas listing, can be used as a clinical trial data for medical devices registered in the Chinese declaration."

 

It is conducive to the simultaneous listing of innovative medical devices at home and abroad.

 

5, clinical urgent need and scientific and technological innovation, medical equipment approval release

"Drug and medical device for the treatment of life-threatening diseases without effective treatment and is of great significance to solve the clinical requirement of drugs and medical devices, clinical trials in early stage of indicators can predict the curative effect and clinical value of the conditional approval. We should encourage the development of innovative drugs and medical devices, and give priority to the review and approval of innovative drugs and medical devices that are included in the national science and technology major projects and the national key research and development plan."

 

Clinical urgent need and national recognized scientific and technological innovation of medical devices, approval of the listing speed.

 

6, rare disease treatment, medical equipment R & D and approval release

Supporting the development of rare disease drugs and medical devices. The rare disease catalogue was published by the health and family planning department, and the registration system for rare patients was established. Rare disease treatment drugs and medical device applicants can submit a clinical trial application, speed up the approval of rare disease medical equipment review and approval. For foreign rare drugs and medical devices that have been approved for sale, they can be conditionally approved for listing and make relevant research within the prescribed time after listing."

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