Key Benefits:
The Minister of Health and Solidarity,
In view of the Public Health Code, including articles L. 1123-10 and R. 1123-53;
On the proposal of the Director General of the French Agency Health product health security,
Stop:
The safety report for biomedical research on cell therapy preparations is established in accordance with the decree of 19 May 2006 laying down the modalities for the declaration, form and content of the Safety report of biomedical research involving a drug for human use.
For biomedical research involving blood components, organs, tissues of human or animal origin, the safety report referred to in Article R. 1123-53 of the Public Health Code Is transmitted to the French Health Products Safety Agency and to the protection committee of the persons concerned, by electronic means or by mail.
The security report shall be sent within 60 days after the date of the The end of the period covered by this report known as the closing date.
When the sponsor conducts a single search, the closing date of the security report is the anniversary date of the start of the search.
When the proponent conducts several searches on the same product in France or in the European Community, it transmits only one safety report, except where the sponsor is a promoter mentioned at 12 ° Section L. 1123-14 of the Public Health Code and presents serious reasons that prevent it from providing this unique report.
The closing date of this unique safety report is the anniversary of the beginning of the first Research in France.
This unique safety report includes, on the one hand, a global analysis of the security profile of the product on which the research takes into account all the new relevant safety data associated with its Use, as well as an analysis of their possible consequences for the research subject to this report and, on the other hand, a safety report for each of the relevant research as defined in Article 4 of the present Stopped.
There are three parts to the security report:
I. -A security analysis of the
people who are suitable for searching
It includes a concise description of all known safety data from the sponsor, an analysis of their impact on the safety of these individuals, The safety profile of the product on which the research relates and the report of the benefits and risks of the research and a description of the measures taken or to be taken where appropriate. This analysis includes, in particular:
A description of the relevant new data, brought to the attention of the sponsor during the period covered by the report, relating to the safety of the products on which the research relates, others Treatments used in research or diagnostic procedures or investigations conducted during the research. The conclusions and recommendations of the independent monitoring committee referred to in Article L. 1123-7 of the Public Health Code are, where appropriate, attached and commented on.
New relevant product data Those not included in the reference document in effect at the beginning of the security report period, that is, in the investigator's brochure.
An analysis of the product's safety profile and its impact on the Population treated. This analysis shall take into account all relevant safety data available, including the anticipated exit from the search for safety reasons and the results of any biomedical or non-clinical research and Any data related to the use of this product. It shall specify the number of persons who have received the product on which the research is carried out and, where appropriate, outside the research covered by this report.
When medically relevant, this analysis takes into account, inter alia:
a) A relationship of effects with dose, duration, and timing of treatment;
b) Reversibility of effects;
c) Highlight of previously unknown risk;
d) Increased frequency of occurrence Adverse reactions;
e) overdose and its treatment;
f) Any interaction or other risk factor identified;
g) Any safety data specific to certain categories of persons, such as Older subjects or minors;
h) Any information available, positive or negative, relating to the use of the product on which the research is being conducted during pregnancy or breast-feeding;
i) Any risks that may be related to Investigations or diagnostic procedures used in biomedical research;
j) Any risks that might be related to a quality defect in the research product.
An analysis of the impact of this information on Persons who lend themselves to the research, including a description of the measures taken or to be taken in order to reduce the risks identified, as well as the description and reasons for the modifications to the protocol, to the document Information for those who are suitable for research, how to collect their consent, or the brochure for the investigator, if any.
An up-to-date assessment of the benefits and risks of the research.
II. -The list of all suspected serious adverse reactions in France and outside the national territory in the research concerned, during the period covered by the report
The list is identified by a reference number or Date and time of printing
These suspected serious adverse reactions are organized according to a classification by system or body.
For each suspicion of serious adverse reaction, the list contains the information
a) The identification of biomedical research;
b) The code number identifying the person who is ready for the research in which the adverse reaction was found;
c) The reference number of the suspicion of effect Adverse reaction attributed by the sponsor;
d) The country in which the suspected adverse reaction occurred;
e) The age and sex of the person who is willing to conduct the research in which the suspected adverse reaction has been identified ;
f) If applicable, the quantity of the product administered and, where relevant, its route of administration;
g) The start date of the suspected adverse reaction or, if not available, the most appropriate estimate The time elapsed between the graft or the administration of the product and the occurrence of the effect;
h) The dates of the graft or administration of the product and, where applicable, the estimate of the duration of the treatment;
i) The description of the product The adverse reaction as reported to the sponsor and, as appropriate, as interpreted by the sponsor; where appropriate, the diagnosis can replace the signs and symptoms;
j) The development of the serious adverse reaction (s): Healing, in the process of improvement, having caused sequelae, unknown evolution, death. In the case of multiple adverse reactions, the proponent shall mention the most serious development;
(k) Any relevant comments on the suspicion of serious adverse reaction, including:
-the assessment of causality, particularly in the case of Disagreement between the sponsor and the investigator;
-the direct effect of the product being investigated or the effect of the interaction with another treatment;
-the medical condition or condition treated with the product (s) Suspected;
-results of the suspected stop of the treatment or its possible re-introduction;
l) If applicable, the result of the unblinding.
If applicable, can be established for the same search on separate lists Serious adverse events, based on other duly justified criteria.
III. -Summary tables containing all the signs and symptoms or diagnoses of serious adverse events since the beginning of the research allowing a global view of the test
These tables specify the number of cases identified:
-for each physiological system or organ concerned;
-for each adverse effect name, specifying its expected or unexpected character;
-where applicable, for each treatment group after the unblinding: product on Which carries the search, reference product or placebo;
-if applicable, for the product administered or grafted before unblinding.
When the sponsor conducts a biomedical research whose duration does not exceed six months, the sponsor transmits the safety report within ninety days after the end of the research, with the Declaration of the end of the research referred to in Article R. 1123-59 of the Public Health Code.
The Director General of the French Health Products Safety Agency is responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
Done at Paris, December 15, 2006.
For the minister and delegation:
The head of the
health policy service and the health system quality,
D. Eyssartier
