Based on past experience, the IVD clinical trial unit selection is basically to the third-class clinical trial organization as a guideline, in the past review process basically does not exist in the clinical trial unit qualification issued to supplement the problem.
But from January 2013, the State Food and Drug Administration Medical Device Evaluation Center issued a supplemental notice of in vitro diagnostic reagent products seem to have started one after another on the qualification of the clinical trial unit requirements. If the three clinical trial units, including non-provincial medical institutions, non-drug GCP units, supplemental notification of clinical trials often need to be supplemented with the submission of "the qualification documents of this clinical trial unit".
For example, municipal CDC, municipal hospitals, special institutions and other non-drug GCP qualification of clinical units need to submit qualification documents, except for military hospitals.
So you must be wondering if you really received the need to supplement the "qualification documents", what exactly to provide?
In fact, it is to prove that this clinical trial unit to meet the "in vitro diagnostic reagents clinical research technical guidelines" inside the relevant clinical research units and personnel requirements, simply summarized as:
1. with clinical medical institutions legal entity qualification;
2. with the appropriate professional technical personnel, instruments, sites, etc.;
3. case resources should be able to meet the test requirements. Be able to meet the test requirements, etc.
After the release of the new Administrative Measures for the Registration of In Vitro Diagnostic Reagents and the Technical Guiding Principles for Clinical Trials of In Vitro Diagnostic Reagents, the requirements for clinical trial organizations have been raised even higher, and clinical trial organizations have been asked to undertake clinical trials of in vitro diagnostic reagents as if they were medicines, and if they are required to undertake clinical trials of in vitro diagnostic reagents, the relevant professional departments need to be professionally accredited, which is estimated to be a major factor for the State Food and Drug Administration to consider. is also taking into account the professional qualification is not a short period of time can be completed things, in this regard, it was issued on August 1, 2014 "on the implementation of" medical device registration management "and" in vitro diagnostic reagent registration management approach "related matters of the notice" (food and drug supervision and management of in vitro diagnostic reagents 〔2014〕 No. 144), the relevant provisions are as follows:
VII. (C) on in vitro diagnostic reagent clinical trials:
Before the State Food and Drug Administration issued the directory of medical device clinical trial organizations, the applicant shall carry out clinical trials of in vitro diagnostic reagents in provincial health care institutions.
For special-purpose products, in vitro diagnostic reagent clinical trials can be carried out at the municipal level or above in line with the requirements of disease control centers, specialized hospitals or inspection and quarantine institutes, drug rehabilitation centers and other institutions.
From the above provisions we can see that the current in vitro diagnostic reagents can also be implemented in accordance with previous requirements for clinical trials. Therefore, for the current period, we call the transition phase, for which, although it seems to be no difference with the previous, but don't forget, we will later submit the product registration information there is a new requirement that must be submitted to the lunli review opinion oh!
Lastly, for the selection of clinical trial units, I suggest that we try to choose the unit with the drug GCP qualification, not only to meet the requirements of the qualification, but also to successfully obtain the lunli review opinion. Because as long as the drug GCP qualification unit, basically have set up lunli committee.