When clinical trial applications are submitted, little or no data exist concerning reproductive toxicity. This is particularly the case for early phase clinical trials. At a time where a benefit to the mother is not yet firmly established, damage to the unborn child must absolutely be avoided.
This document is intended for ALL clinical trials that are submitted. Sponsors are asked to pay attention to this document and to clearly justify their strategy for contraceptive measures during clinical trials.
One of the main sessions during the Belgian Pharmaceutical Conference Terhulpen, 17th of April covered clinical research in Belgium. An important topic, because clinical research is more then just a way to gather evidence for future medicinal products : it is also an important job creator almost For patients, the participation to clinical trials can mean an early access to innovative medicines.
The results of this investigation were presented — the presentation can be downloaded HERE. Federal Agency for Medicines and Healthproducts. Research and development department. Special requirements: In view of the particular nature of the production method, it is possible to grant a "conditional approval" for the annual update of flue vaccines that have already been authorised.
The law of 7 May has been modified several times see below Note: the laws, royal decrees and circulars are except for a few not translated in English. Laws Law dated 7th May French version related to experiments on human people.
Royal Decree dated 30th June French version determining the measures for carrying out the law dated 7th May French version relating to experiments on human people concerning clinical trials of medicines for human use, modified by the Royal Decree dated 18th May French version Royal Decree dated 15th July French version determining the fees to be paid for a request for an opinion or for authorisation to conduct a clinical trial or an experiment.
Orientation documents Exploratory clinical trial: guidance version 3 - June Eudralex Volume Notification of adverse reactions or incidents. Give your opinion on a genetically modified medicine for the treatment of various types of advanced cancer. Limited availability of RoActemra Roche : new situation update. Request A Demo. Please fill out the form below and one of our team members will get back to you as soon as possible!
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FAMHP organises two information sessions to provide all sponsors and applicants for clinical trials with as much information as possible about the new Regulation. BeCRO is actively involved in the organisation of these workshops. The first information session took place on 23 September An intro to the legal situation for regulatory, pricing and reimbursement in Belgium.
In particular, the FAMHP is in charge of controlling the quality, safety and efficacy of those products. For drugs and biologicals, the general framework, including in relation to the authorisation, of drugs, biologicals and medical devices can be found in the following laws and regulations:.
Specific provisions relating the pricing of medical products and certain medical devices are found in:. The procedure to obtain an authorisation for medical devices is quite different.
To put a medical device on the market, it needs to bear the CE marking. The fees for the MA of the medicines are the following, depending on the type of procedure chosen by the applicant:. MAs are valid for five years. An application for renewal of a national MA must be submitted through the national procedure or the mutual recognition procedure at least nine months prior to the expiring date of its validity.
After the first renewal, MAs are valid for an indefinite time. Since 1 January , the use of the electronic form for the submission of a MA renewal application has become mandatory. Generic products can be authorized through a so-called abbreviated procedure, meaning that the applicant is not required to submit a complete file to receive a MA and can rely on the documents already submitted for the brandname product.
The presentation of pre-clinical and clinical trials is not required if the applicant can demonstrate that the medicine for human use is a generic of a reference medicine for human use which is or has been authorised for at least eight years in Belgium or in another Member State i. Once this period of data exclusivity has expired, the MA application can be submitted, as well as the pricing and reimbursement application.
However, an additional two or in some cases three year period is required before the generic drug can be marketed i. There is no specific regulation for combined products. However, it is important to emphasize that even if biologic products are classified as medicines, they are subject to different rules than the medicines in general.
The FAMHP is responsible for monitoring the correct application of the laws and decrees in force in the field of medicines. To this end, the FAMHP is legally authorised to carry out inspections, searches, analyses, interrogations, seizures, etc.
The regulatory regime is based on the EU directives on medicines and medical devices and is in line with the European Medicines Agency expectations and requirements. In the event of a violation of one of the above-mentioned provisions, the FAMHP may impose various sanctions such as: imposing an administrative fine, withdrawing or adapting official documents, taking a health measure or introducing a ban.
Any person residing in Belgium is subject to a regime of compulsory insurance. Any Belgian resident over 25 years whether they are employees, self-employed, unemployed, retired, students, etc. Indeed, the health insurance funds allow the insured party to be reimbursed in whole or in part for certain medical intervention and medicines. These funds are managed by the NIHDI, which is the federal body that organises, manages and controls health care in Belgium, which in turn distributes the funds received between the various health insurance funds.
The public healthcare system is the mandatory system under Belgian law and it reimburses treatment at an official price per intervention.
Still, there is a difference for what the type of healthcare professional, conventionalised or not, is concerned. The health insurance fund comes to an agreement with the healthcare professionals, inter alia regarding the prices. Healthcare professionals who agree with the official prices, are conventionalised and obliged to charge the official prices only.
Partially conventionalised healthcare professionals charge the official prices in certain facilities e. Non-conventionalised healthcare professionals always charge their own prices.
Once the marketing authorisation is granted, the pharmaceutical firm can only market the product following the setting of a maximum price by the FPS Economy. Within 90 days and after the latter has issued an opinion, the Minister of the Economy takes a ministerial decree indicating the maximum authorised price for the medicine.
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