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The applicable
legislation concerning clinical trials in France, the Huriet-Sérusclat
law of 1988, is currently being revised. The requirements of the European
Directive 2001/20/EC, which are to be implemented by 1 May 2004, are
being integrated.
The French Health Products Safety Agency (AFSSAPS), which was created
in 1998, is the competent authority for safety decisions concerning
health products. Till the beginning of 2004, the AFSSAPS had only
to be notified about the intention to perform a clinical trial. When
the new legislation comes into force, however, an application for
authorisation of the clinical trial must be submitted to the AFSSAPS,
in accordance with the regulations of Directive 2001/20/EC. The clinical
trial protocol and other relevant information have to be submitted
for review. In addition, the favourable opinion of the responsible
Ethics Committee (EC) - "comité de protection des personnes dans la
recherche", CPPR (in the past called CCPPRB) - must be obtained and
forwarded to the AFSSAPS. The clinical trial may not be commenced
until authorisation has been granted.
In November 2003, AFSSAPS started a six-month pilot phase for evaluating
authorisation requests relating to phase I clinical trials, based
on Directive 2001/20/EC.
 French
issue interim guidance on clinical trials
AFSSAPS has recently issued transitional guidance on the conduct of
clinical studies afer May 1st, 2004, because French legislation implementing
the EU Clinical Trials Directive has still not been approved.
AFSSAPS says trials should be split into two categories, ie, beginning
either before or after May 1st. For studies already underway as of
this date, sponsors are advised to continue them under the existing
legislation (the 1988 "Huriet law").
For trials that are scheduled to begin after May 1st, the agency says
sponsors have three choices. Firstly, they can continue and complete
the trial under the Huriet law, applying its provisions to the beginning,
monitoring and completion of the trial.
Alternatively, they can take advantage of a pilot scheme that AFSSAPS
put in place in November last year in preparation for the Directive's
transposition. This essentially means that sponsors apply those provisions
of the Directive that are covered by the scheme. At present it covers
just the start of phase I trials, but it is being extended to cover
all types of trials (phases I-IV) as well as monitoring (side-effect
reporting, modifications etc) and completion.
The third option is to follow the Huriet law but to apply all of the
provisions of the Directive relating to safety reporting.
The implementation will not be effective before the beginning of 2005.
Until that time nothing changes (approval in 2 weeks after submitting
the protocol and investigator brochure to the EC).
After the publication of the decrees (2005), the AFSSAPS plans to
approve phase I clinical studies within 14 days and within 30 days
for later phase studies. Parallel submissions to EC will have the
same timelines.
Trials initiated after the publication of the decrees:
The new public health law and relevant decrees apply from the first
day of the publication.
Trials initiated before the publication of the decrees:
A transition period is planned for ongoing clinical trials. After
a delay (up to one year), all trials must be in accordance with the
new rules.
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| Information/Documents to submit:
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Type
Protocol
Investigator Brochure
Inform Consent Form
Subject Information
Eudract nr + application form
Insurance Certificate
CV of Principal Investigator
Clinical Pharmacology Unit authorisation
List of CA's submitted to
IMP dossier, i.e. Qualified Person declaration; Manufacturer's Licence;
TSE certification; Viral safety study; Import licence (for non- EU
countries); Certificate of analysis.
EC opinions (if available)
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EC
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–
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| For updating: French
Health Products Safety Agency (AFSSAPS)
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2005/or
after publication of the decrees:
Sumary of issues and changes for clinical trials:
- Competent Authority (CA): authorisation in stead of notification
- Reviews by EC and CA in parallel
- English documents accepted (ICF + subject information in French)
- Timelines: between submission and approval
Actual: < 20 days
Future: < 15 days for phase I and <
30 days for other phases
No changes regarding:
- EC submission and process
- Clinical Pharmacology Unit's inspections and authorisation
- Insurance certificate
- Manufacturing inspections/Import permit
New:
- CTA submission to CA (incl. Qualified Person declaration)
- Written authorisation of French Agency
- Notification of study finalisation
- Study safety summary and annual safety report
Important notes:
- No Investigational Medicine Product (IMPD) information to EC
- No submission to the CA needed if study starts before the publication
of the
decrees
France
sets new taxes on biomedical research
Companies applying to the French medicines regulator Afssaps for authorisation to carry out biomedical research must now pay special taxes when submitting their dossiers.
A base tax must be paid whether or not the agency approves the research proposal. An additional tax applies when an ethics committee must give its opinion on a study or advise on the collection of biological samples.
Further taxes are charged if a research project is substantially modified, if an ethics committee must be consulted a second time or if human tissues, organs or blood products are to be used for a purpose other than the one for which they were collected.
Public sector researchers, including universities and hospitals, pay just 10% of the tax.
| Application and ethical review: |
Tax (€)
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| Medicinal product |
4,000
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| Experimental medicine (first in man) |
3,000
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| Therapeutic biological product |
4,000
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| Transplants or first-in-man biologicals |
3,000
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| Medical device |
4,000
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| Cosmetics (including tattoo products) |
4,000
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| Substantial change in research proposal |
500
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| Second ethics committee review |
2,000
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| Ethics committee
review (only) of: |
| Comparative clinical practice study |
3,000
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| Collection of biological samples |
2,000
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| Change in use of biological samples |
2,000
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Health
Care System
The French healthcare system is a branch of the social security system
and is funded to a large extent by obligatory contributions from employees
and employers. Medical treatment costs are normally covered only partially
(about 80%) by social security. For this reason the majority of the
population have supplementary private insurance. Serious illnesses,
however, are covered 100%.
In France, people are free to consult any doctor or specialist; referral
from a GP is not necessary in order to see a specialist.
Clinical
Trials Management
ECRON/Biotrial’s clinical staff has developed professional experience
in the management of phase II-IV clinical trials. We have covered
a large range of therapeutic areas, particularly in the CNS and cardiovascular
fields. In a study, 250 Alzheimer patients were enrolled within 6
months at 23 active sites. In this particular disease, 10 large phase
II-III studies have been carried out by Biotrial in recent years.
Senior Clinical Research Associates (CRAs) and a ECRON/Biotrial Clinical
Project Manager with experience in the field of investigation are
assigned to each trial. Our CRAs are trained in the techniques of
US and European GCPs. They work on-site with personnel to ensure compliance
with SOPs and GCPs.
Phase
I Trials
The phase I units (Rennes-92 beds and Paris-24 beds) provide comprehensive
clinical pharmacology services covering all stages of drug evaluation.
Brittany
Oncology Trial Centre
Aware of the specific constraints of clinical oncology studies, Biotrial
and the Eugene Marquis Cancer Institute (EMCI) have set up a joint
venture to provide fast and flexible support to pharmaceutical companies
involved in anticancer drug research.
This organization commonly known as Brittany oncology Trial Center
(BOTC), offers a rare combination of services for the adequate carrying
out of oncology studies. The close proximity of ECRON/Biotrial and
the EMCI allow the joint management of BOTC to follow the progress
of the study on a day-by-day basis, and to meet whenever required.
The nursing staff of Biotrial is available to perform key sampling
and examinations required by the protocol. ECRON/Biotrial’s nurses,
trained to ensure the quality of studies conducted in healthy volunteers,
go to the cancer institutes or to the patient’s residence in case
of studies performed in outpatient.
Local
office/staff
ECRON / Biotrial
1, Rue Charles Drot, 92502 Rueil Malmaison (Paris), Stell Clinic,
France
Phone: +33 (1) 47 328 400 Fax: +33 (1) 47 328 419
Rue Jean-Louis Bertrand, Technopole Atalante Villejean, 35000 Rennes
Phone: +33 (2) 99 599 191 Fax: +33 (2) 99 599 199
Email: bd@ecronacunova.com
Authorities
Ministry of Health
French Health
Products Safety Agency (AFSSAPS)
Agence Francaise de Sécurité Sanitaire des Produits de Santé
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Jean-Marc Gandon,
PharmD
President Biotrial, France |
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FRANCE
