natgillin/translations-raw huggingface dataset:
C'est pour cela que les enfants ont besoin d'une forme pharmaceutique différente de celle destinée à l'adulte, non seulement pour qu'elle soit mieux tolérée, mais également pour qu'elle soit davantage efficace.
This is why children need pharmaceutical forms different from those intended for adults, so as to ensure both that the medicines are better tolerated and that they are more efficacious.
L'Union européenne doit ainsi se doter de moyens efficaces pour aider au développement de médicaments pédiatriques, et palier cette carence importante au niveau de la santé publique.
The European Union therefore needs to introduce effective means of promoting the development of paediatric medicinal products, so as to make good this major shortcoming in public health systems.
Pour être efficace, ce règlement doit comporter un plan d'actions qui passe notamment par la mise en place de mesures incitatives précises, réalistes et clairement définies.
In order to be effective, this regulation needs to include an action plan that provides in particular for the introduction of targeted, realistic and clear incentives.
Le développement de produits spécifiques pour les enfants implique des considérations particulières : D'une part, avant de commencer toute étude, il faut répondre à la nécessité du besoin et savoir si le futur médicament bénéficiera ou non aux enfants ?
A number of factors need to be taken into account when developing medicinal products specifically intended for children.
L'une des grandes difficultés dans le développement des médicaments pédiatriques réside dans les études cliniques.
Before any studies are embarked upon, we need to know whether there is a need for them and whether the prospective medicinal product will be of benefit to children or not.
Aussi, il convient d'éviter de refaire des tests qui ont déjà donnés lieu à des résultats, ou d'en réaliser inutilement.
One of the issues of most concern during the development of paediatric medicinal products is that of clinical trials: only trials that are absolutely necessary should be carried out, and trials that have already produced results should not be repeated.
D'autre part, la création du comité pédiatrique constitue le socle de la réussite de ce règlement.
The success of this regulation is dependent on the setting up of a Paediatric Committee.
Il doit donc pouvoir se prononcer pour chaque dossier relevant de la pédiatrie.
The committee therefore needs to give its views on each and every paediatric dossier.
Ce comité sera la pierre angulaire du dispositif, notamment en accompagnant la réalisation des plans d'investigation pédiatrique en partenariat avec les demandeurs.
The committee will be the cornerstone of the system, owing in particular to its involvement in paediatric investigation plans in partnership with the applicants.
Par les amendements proposés, il s'agit de bien identifier les missions de ce comité, de clarifier le dispositif, d'assurer le suivi des plans d'investigation pédiatriques, tout en accordant à ce comité la mission importante d'identifier les besoins spécifiques en pédiatrie.
The amendments tabled seek clearly to establish the committee’s tasks, to clarify the system and to ensure proper monitoring of paediatric investigation plans, while giving the committee the important job of identifying specific needs in the paediatric sector.
La mise à disposition de produits destinés aux enfants ne doit pas entraver le développement de médicaments pour adultes.
However, the development of medicinal products specifically intended for children must not be allowed to hamper the development of medicines for adults.
C'est pour cette raison évidente que le rapporteur propose la possibilité de ne pas rendre effective l'obligation de présenter simultanément le résultat des études pédiatriques et le résultat de celles destinés à l'adulte.
This is why the rapporteur has sought to ensure that the results of the paediatric studies do not necessarily have to be submitted at the same time as those of the studies in adults.
Dans le cas où le demandeur ne dépose pas en même temps ces deux informations, le comité pédiatrique devra faire en sorte de s'entendre avec le demandeur sur un calendrier précis.
In cases where the applicant does not have the results of both ready at the same time, the Paediatric Committee will need to agree on a precise timetable with the applicant.
L'objectif étant l'instauration d'un véritable dialogue entre les deux parties, un dialogue encadré permettant à la fois le suivi et la responsabilisation des partenaires pour ne pas abandonner la recherche.
The aim is to establish a proper, structured dialogue between the two parties with a view ensuring that partners are monitored and reminded of their responsibilities, and thus preventing the research work from being abandoned.
Le rapporteur souhaite également réduire les différents délais administratifs, permettre la diffusion au public de certaines informations, et soulève la question importante du budget alloué à la pharmacovigilance.
The rapporteur has also sought to tighten up administrative deadlines and ensure that the public is given information, and has raised the important issue of the budget allocated to pharmacovigilance.
Enfin, la Commission européenne initie dans son exposé des motifs la possibilité de création du Medicines Investigation for the Children of Europe (MICE) mais n'y fait référence dans aucun article.
Lastly, in its explanatory memorandum the Commission mentions the possibility of setting up the Medicines Investigation for the Children of Europe (MICE) programme, but makes no reference to it in the regulation itself.
k návrhu nařízení Evropského parlamentu a Rady o léčivých přípravcích pro pediatrické použití a o změně nařízení Rady (EHS) č. 1768/92, směrnice 2001/83/ES a nařízení (ES) č. 726/2004
on the proposal for a Regulation of the European Parliament and the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004
This regulation, once adopted and implemented, will represent a significant improvement in the rules relating to medicinal products for paediatric use, with the aim of guaranteeing safer and more effective pharmaceutical products for children.
This regulation, once adopted and implemented, will represent a significant improvement in the rules relating to medicinal products for paediatric use, with the aim of guaranteeing safer and more effective pharmaceutical products for children.
The proposal supports the development, and therefore an increase in supply, of medicinal products for children that are specifically authorised and developed for paediatric use on the basis of high-quality research.
The proposal supports the development, and therefore an increase in supply, of medicinal products for children that are specifically authorised and developed for paediatric use on the basis of high-quality research.
The necessity and importance of the Regulation is immediately clear from one simple statistic: over 50% of the medicinal products used in Europe today to treat children are not subject to testing or authorised for paediatric use.
The necessity and importance of the Regulation is immediately clear from one simple statistic: over 50% of the medicinal products used in Europe today to treat children are not subject to testing or authorised for paediatric use.
Your draftswoman, who agrees with the end goals and the main proposals of the Regulation and emphasises that there is broad consensus among the players concerned as regards these proposals, wishes to make the following remarks:
Your draftswoman, who agrees with the end goals and the main proposals of the Regulation and emphasises that there is broad consensus among the players concerned as regards these proposals, wishes to make the following remarks:
Paediatric Committee and Paediatric Investigation Plans (PIPs)
Paediatric Committee and Paediatric Investigation Plans (PIPs)
The creation of the body responsible for evaluating and approving the Paediatric Investigation Plans should be viewed as a positive development.
The creation of the body responsible for evaluating and approving the Paediatric Investigation Plans should be viewed as a positive development.
Your draftswoman considers that the tasks and criteria relating to evaluations and the further responsibilities of the Committee itself should be specified more clearly and in practical terms.
Your draftswoman considers that the tasks and criteria relating to evaluations and the further responsibilities of the Committee itself should be specified more clearly and in practical terms.
However, it is also felt that these precise details should not be decided under this initial Regulation, but rather in the subsequent documents for which it provides.
However, it is also felt that these precise details should not be decided under this initial Regulation, but rather in the subsequent documents for which it provides.
It is therefore recommended that these further points be clearly defined in the 'guidelines'.
It is therefore recommended that these further points be clearly defined in the ‘guidelines’.
Your draftswoman also agrees with the Commission's decision that the objective of the development of new pharmaceutical products (or of therapeutic indications, new pharmaceutical forms or new methods of administration), with a view to the placing on the market of products specifically developed and evaluated for use in children, should be attained through a system of requirements and incentives enabling the appropriate research and tests to be developed, without delaying the placing on the market of pharmaceutical products that are already ready for this.
Your draftswoman also agrees with the Commission’s decision that the objective of the development of new pharmaceutical products (or of therapeutic indications, new pharmaceutical forms or new methods of administration), with a view to the placing on the market of products specifically developed and evaluated for use in children, should be attained through a system of requirements and incentives enabling the appropriate research and tests to be developed, without delaying the placing on the market of pharmaceutical products that are already ready for this.
It should nevertheless be emphasised that this system (which is based on a balancing of rules, requirements and incentives) can only function effectively if the rules are clear and controlled and, above all, incentives are geared selectively and proportionately to the efforts required.
It should nevertheless be emphasised that this system (which is based on a balancing of rules, requirements and incentives) can only function effectively if the rules are clear and controlled and, above all, incentives are geared selectively and proportionately to the efforts required.
An excessively uniform incentive is liable to be too vague and thus ineffective.
An excessively uniform incentive is liable to be too vague and thus ineffective.
In this connection, your draftswoman believes that the incentive concerning the 'six-month extension of the certificate' (i.e. for a fixed period which is the same for everyone) is only acceptable in that to date - i.e. on initial submission of the Regulation - a more selective and proportional procedure is not easily achievable in practical terms, owing both to the lack of significant statistics and to the difficulty of putting such a system into action.
In this connection, your draftswoman believes that the incentive concerning the ‘six-month extension of the certificate’ (i.e. for a fixed period which is the same for everyone) is only acceptable in that to date - i.e. on initial submission of the Regulation - a more selective and proportional procedure is not easily achievable in practical terms, owing both to the lack of significant statistics and to the difficulty of putting such a system into action.
Provision should therefore be made for the results obtained to be assessed, after an initial period of implementation of the Regulation, to check that the incentives are suitable and correspond to the objectives, and to schedule a possible review of the Regulation.
Provision should therefore be made for the results obtained to be assessed, after an initial period of implementation of the Regulation, to check that the incentives are suitable and correspond to the objectives, and to schedule a possible review of the Regulation.
Dissemination of information and statistics
Dissemination of information and statistics
It is important that the studies and trials provided for and put into effect under the PIPs should not solely be notified to the entity responsible for authorising the placing on the market of pharmaceuticals (on the basis of those studies).
It is important that the studies and trials provided for and put into effect under the PIPs should not solely be notified to the entity responsible for authorising the placing on the market of pharmaceuticals (on the basis of those studies).
They should also be notified to the Paediatric Committee, which will have approved the proposal relating to them, and to all organisations operating in the field of research and clinical trials, in order to maximise the results of research, and of course to avoid duplications of effort, thereby enhancing the availability of information on the use of paediatric medicines in general.
They should also be notified to the Paediatric Committee, which will have approved the proposal relating to them, and to all organisations operating in the field of research and clinical trials, in order to maximise the results of research, and of course to avoid duplications of effort, thereby enhancing the availability of information on the use of paediatric medicines in general.
Timing and procedures
Timing and procedures
Observations have been made by some of the parties concerned by the Regulation on the timing in the Commission proposal.
Observations have been made by some of the parties concerned by the Regulation on the timing in the Commission proposal.
It has been pointed out in particular that the Paediatric Committee is involved at too early a stage with respect to the development of the product.
It has been pointed out in particular that the Paediatric Committee is involved at too early a stage with respect to the development of the product.
Your draftswoman does not believe it appropriate to bring forward amendments on this point at this stage in the consideration of the Regulation.
Your draftswoman does not believe it appropriate to bring forward amendments on this point at this stage in the consideration of the Regulation.
On the other hand, your draftswoman considers it necessary to speed up the PIP assessment phase and to shorten, with an eye to accelerating the process, the times laid down for the various stages involved.
On the other hand, your draftswoman considers it necessary to speed up the PIP assessment phase and to shorten, with an eye to accelerating the process, the times laid down for the various stages involved.
Support for research
Support for research
It is absolutely essential for there to be strong and widespread support for research in the field of child pharmacology.
It is absolutely essential for there to be strong and widespread support for research in the field of child pharmacology.
Everyone is quite clear that child health is a primary objective both from a social standpoint and from that of protecting the rights of consumers - consumers who in this case are particularly susceptible and vulnerable and to whom extra attention should be awarded precisely because they cannot speak for themselves and only through their parents and family.
Everyone is quite clear that child health is a primary objective both from a social standpoint and from that of protecting the rights of consumers - consumers who in this case are particularly susceptible and vulnerable and to whom extra attention should be awarded precisely because they cannot speak for themselves and only through their parents and family.
Furthermore, this objective also coincides with that of supporting innovation in the pharmacological field, and dovetails with the major commitment the Commission will enter into in the field of research with the launch of the Seventh Framework Programme.
Furthermore, this objective also coincides with that of supporting innovation in the pharmacological field, and dovetails with the major commitment the Commission will enter into in the field of research with the launch of the Seventh Framework Programme.
For these reasons, your draftswoman views the Commission's proposal relating to Medicines Investigation for the Children of Europe (MICE) as too vague (the proposal simply states that "the Commission intends to examine the possibility of setting up a paediatric study programme") and calls for that instrument to be laid down in this Regulation, or at least for a more precise and explicit commitment to be made and for procedures, timing and resources to be defined.
For these reasons, your draftswoman views the Commission’s proposal relating to Medicines Investigation for the Children of Europe (MICE) as too vague (the proposal simply states that "the Commission intends to examine the possibility of setting up a paediatric study programme") and calls for that instrument to be laid down in this Regulation, or at least for a more precise and explicit commitment to be made and for procedures, timing and resources to be defined.
Výbor pro průmysl, výzkum a energetiku vyzývá Výbor pro životní prostředí, veřejné zdraví a bezpečnost potravin jako příslušný výbor, aby do své zprávy začlenil tyto pozměňovací návrhy:
The Committee on Industry, Research and Energy calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:
Dosud nezveřejněné v Úředním věstníku.
Not yet published in Official Journal.
B od odůvodnění 8
RECITAL 8
Tento Pediatrický výbor by měl být odpovědný zejména za posuzování a schvalování plánů pediatrického výzkumu a v souvislosti s nimi za systém prominutí a odkladů a měl by rovněž hrát ústřední roli při různých podpůrných opatřeních obsažených v tomto nařízení.
The Paediatric Committee should be primarily responsible for the assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof , and it should also be central to various support measures contained in this Regulation.
Při vší své práci by Pediatrický výbor měl brát v úvahu potenciální významné léčebné přínosy studií prováděných u dětí, včetně nutnosti zabránit zbytečným studiím.
In all its work the Paediatric Committee should consider the potential significant therapeutic benefits of studies in children including the need to avoid unnecessary studies.
Měl by rovněž hrát ústřední roli při různých podpůrných opatřeních obsažených v tomto nařízení.
It should also be central to various support measures contained in this Regulation.
The Paediatric Committee must perform its duties autonomously and in the interests of the paediatric population.
The Paediatric Committee must perform its duties autonomously and in the interests of the paediatric population.
It is therefore important to emphasise its independence from the pharmaceutical industry.
It is therefore important to emphasise its independence from the pharmaceutical industry.
B od odůvodnění 10
RECITAL 10
Proto by měly být plány pediatrického výzkumu předkládány v rané fázi v průběhu vývoje přípravku, aby byl před předložením žádostí o registraci čas na provedení potřebných studií u dětí a ve všech případech, kdy je to možné .
Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in children , and, wherever possible, before marketing authorisation applications are submitted.
The timing set to submit the paediatric investigation plan, i.e., at the completion of the human pharmaco-kinetic studies in adults, is too early and is too specific a milestone in the medicinal product development cycle.
The timing set to submit the paediatric investigation plan, i.e., at the completion of the human pharmaco-kinetic studies in adults, is too early and is too specific a milestone in the medicinal product development cycle.
At this stage, it is premature for most products to require producing a detailed paediatric investigation plan.
At this stage, it is premature for most products to require producing a detailed paediatric investigation plan.
It would only be possible to develop a vague paediatric plan because of the lack of in-depth safety evaluation of a new molecule in adults generally required before considering the conduct of studies in children.
It would only be possible to develop a vague paediatric plan because of the lack of in-depth safety evaluation of a new molecule in adults generally required before considering the conduct of studies in children.
B od odůvodnění 11a (nový)
RECITAL 11 a (new)
Je nezbytné zavést MICE (Zkoumání léčivých přípravků pro děti v Evropě).
It is necessary to establish the MICE (Medicines Investigation for the Children of Europe ).
It is essential to provide funding under Community research programmes to encourage research on and testing of medicinal products for paediatric use.
It is essential to provide funding under Community research programmes to encourage research on and testing of medicinal products for paediatric use.
Without a specific financial instrument the pharmaceutical industry would have no incentive to conduct studies into paediatric applications for pharmaceutical products not covered by a patent or a Supplementary Protection Certificate.
Without a specific financial instrument the pharmaceutical industry would have no incentive to conduct studies into paediatric applications for pharmaceutical products not covered by a patent or a Supplementary Protection Certificate.
B od odůvodnění 21
RECITAL 21
V e zvláštních případech ovlivněných administrativními průtahy by měly být příslušné orgány schopny povolit výjimky z tohoto ustanovení.
The competent authorities should be able, in specific cases affected by administrative delays, to grant derogations from this provision.
Takové výjimky musí být patřičně zdůvodněny.
Any such derogations should be justified on duly substantiated grounds.
The placing of a product on the market may be delayed due to the time taken by the administrative procedures which determine the setting of prices and level of reimbursement.
The placing of a product on the market may be delayed due to the time taken by the administrative procedures which determine the setting of prices and level of reimbursement.
All this is beyond the control of the marketing authorisation holder who is, nevertheless, required to take all the necessary steps prior to marketing the product.
All this is beyond the control of the marketing authorisation holder who is, nevertheless, required to take all the necessary steps prior to marketing the product.
B od odůvodnění 22
RECITAL 22
Mezitím by bylo žádoucí sestavení evropského pediatrického formuláře, který by se mohl využít při shromažďování všech dostupných údajů z jednotlivých členských zemí o určitém přípravku, který by měl být uveden na trh v rámci celé Unie, ale v dané chvíli je v prodeji pouze v daném státě .
In the meantime, it would be desirable for a European paediatric form to be drawn up to serve as a reference for the collection of all the data available in the various Member States on a pharmaceutical product desired to be marketed in the Union but at that moment placed on the market only at national level.
It would be useful to include a procedure that standardises the sets of forms in use in the Member States and paves the way for the introduction of the optional procedure referred to in the recital.
It would be useful to include a procedure that standardises the sets of forms in use in the Member States and paves the way for the introduction of the optional procedure referred to in the recital.