natgillin/translations-raw huggingface dataset:
The European Commission Directorate-General for Enterprise and the EMEA published a joint Priority Action Plan in July 2006 for implementation of the regulation, and a dedicated task-force was set up within the Agency to manage this plan.
Generalni direktorat za podjetništvo Evropske komisije in EMEA sta julija 2006 objavila skupni prednostni akcijski načrt za izvajanje uredbe, za upravljanje tega načrta pa je bila v okviru Agencije oblikovana specializirana projektna skupina.
The Agency organised a number of conferences, workshops and training sessions for assessors and inspectors, designed to share competencies and strengthen cooperation among the network of European experts.
Agencija je organizirala več konferenc, delavnic in usposabljanj za ocenjevalce in inšpektorje, ki so bili namenjeni izmenjavi znanja in krepitev sodelovanja znotraj mreže evropskih strokovnjakov.
Management and internal-control systems are part of EMEA governance and are consolidated in an integrated management system at the Agency.
Sistem upravljanja in sistem notranje kontrole sta sestavna dela upravljanja EMEA ter sta povezana v integriran sistem upravljanja v EMEA.
Increasing availability of medicines for rare diseases
Povečanje razpoložljivosti zdravil za redke bolezni
MANAGING THE AGENCY
UPRAVLJANJE AGENCIJE
European Risk-Management Strategy (ERMS) for medicines for human use
Evropska strategija obvladovanja tveganja (European Risk-Management StrategyERMS) za zdravila za uporabo v humani medicini
Six new contra-indications were also adopted, for medicinal products used in fields such as depression, diabetes and infectious diseases.
Sprejetih je bilo tudi šest novih kontraindikacij za zdravila, ki se uporabljajo na področjih, kot so depresija, sladkorna bolezen in nalezljive bolezni.
The launch of the database is a first step towards providing public access to comprehensive and up-to-date information about all authorised medicines in the European Union.
Uporaba zbirke podatkov je prvi korak k zagotavljanju javnega dostopa do celovitih in najnovejših informacij o vseh zdravilih, ki imajo dovoljenje za promet v Evropski uniji.
In particular, major progress was made on adapting the data requirements for products for minor uses and minor species.
Pomemben napredek je bil dosežen pri prilagajanju podatkovnih zahtev za proizvode za manjšo uporabo in manj pomembne vrste.
As part of its implementation of EU pharmaceutical legislation, the EMEA launched a first version of EudraPharm - a new medicines-information database for the EU - on 6 December 2006.
EMEA je v okviru izvajanja farmacevtske zakonodaje EU 6. decembra 2006 začela uporabljati prvo različico EudraPharm, nove zbirke podatkov informacij o zdravilih za EU.
1.2 Improving access to medicines and stimulating R&D Implementing the new framework for scientific advice
1.2 Izboljšanje dostopa do zdravil in spodbujanje raziskav in razvoja Uvedba novega okvira za znanstveno svetovanje
Europe first to approve biosimilars
Evropa prva odobrila biološko podobne izdelke
6.1 Management Board
6.1 Upravni odbor
Reinforcing the scientific expertise of the Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) by co-opting 8 specialised experts.
Krepitev znanstvenega strokovnega znanja in izkušenj delovne skupine za farmakovigilanco (Pharmacovigilance Working Party - PhVWP) Odbora za zdravila za uporabo v humani medicini (CHMP) z vključitvijo osmih specializiranih članov.
The scientific committees were able to speed up the average assessment time for several key procedures, including initial evaluations, orphan designations and scientific advice, thus helping to accelerate the development and availability of new medicines.
znanstveni odbori so pospešili povprečni čas vrednotenja za več ključnih postopkov, vključno z začetnim vrednotenjem, določanjem zdravil sirot in znanstvenim svetovanjem, in tako pripomogli k pospeševanju razvoja in razpoložljivosti novih zdravil.
Thereafter, subject to budgetary capacity, it is hoped to extend the system to the decentralised and mutual-recognition procedures.
Če bodo na voljo proračunska sredstva, se bo sistem predvidoma razširil tudi na decentraliziran postopek in postopek medsebojnega priznavanja;
First Article 78 procedure
Prvi postopek na podlagi člena 78
The availability of an adequate pharmacovigilance-signals-detection system is important to the Agency's efforts for monitoring the safety of medicines.
Razpoložljivost ustreznega sistema za odkrivanje signalov farmakovigilance je pomembna za prizadevanja Agencije za spremljanje varnosti zdravil.
Efforts to improve public access to information about medicines
Prizadevanja za izboljšanje dostopa javnosti do informacij o zdravilih
The number of procedures for arbitrations, referrals and Article 5(3) opinions started in 2006 was 79% greater than in 2005.
Število postopkov za arbitražo, napotitev in mnenj po členu 5(3), ki so se začeli leta 2006, je bilo za 79 % višje kot leta 2005.
No opinions were adopted on products evaluated through compassionateuse or accelerated-assessment procedures.
Sprejeto ni bilo nobeno mnenje o proizvodih, vrednotenih s postopki za sočutno uporabo zdravil ali postopki za pospešeno ocenjevanje.
In addition to initial notifications, the Agency received 2,201 notifications of a change, representing a 120% increase compared to 2005 (1,018).
Poleg začetnih obvestil je Agencija prejela 2.201 obvestilo o spremembi, kar pomeni 120-odstotno povečanje v primerjavi z letom 2005 (1.018).
Mobilising and coordinating scientific resources from throughout the EU to provide high-quality evaluation of medicinal products, to advise on research and development programmes, to perform inspections for ensuring fundamental GxP1 provisions are consistently achieved, and to provide useful and clear information to users and healthcare professionals.
zbiranjem in usklajevanjem znanstvenih virov iz vse EU zaradi zagotovitve visoke kakovosti vrednotenja zdravil, svetovanje o raziskovalnih in razvojnih programih, izvajanje inšpekcijskih pregledov za zagotavljanje doslednega izvajanja temeljnih določb GXP1 ter zagotovitev uporabnih in jasnih informacij uporabnikom in zdravstvenim delavcem.
Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals.
nadziranjem varnosti zdravil za ljudi in živali, predvsem z mrežo farmakovigilance in določitvijo varnih mejnih vrednosti ostankov v živalih, namenjenih proizvodnji hrane;
Applications withdrawn prior to opinion Negative opinions
Vloge, umaknjene pred sprejetjem mnenja Negativna mnenja
Planning of development work on a production system, following two successful prototypes in 2006, was ongoing at the end of the year.
Konec leta je potekalo načrtovanje razvojnega dela na proizvodnem sistemu po dveh uspešnih prototipih leta 2006.
In addition, the EMEA worked on the development of a pharmacovigilance strategy for antivirals in case of a pandemic-influenza outbreak, taking into account the initiatives taken at industry level.
EMEA je poleg tega delala na razvoju strategije farmakovigilance za protivirusna zdravila, da bi bila na razpolago v primeru izbruha pandemije influence, pri čemer je upoštevala pobude, sprejete na ravni panoge.
For medicinal products that do not fall under any of the above-mentioned categories companies can submit an application for a centralised marketing authorisation to the EMEA, provided the medicinal product constitutes a significant therapeutic, scientific or technical innovation or the product is in any other respect in the interest of patient or animal health.
Za zdravila, ki ne spadajo v nobeno od zgoraj navedenih kategorij, lahko podjetja vložijo vlogo za centralizirano dovoljenje za promet z zdravilom na EMEA, če je zdravilo bistvena terapevtska, znanstvena ali tehnična inovacija ali je proizvod na kakršen koli drug način v interesu zdravja bolnika ali živali.
A further increase in the number of requests for scientific advice was registered in 2006, with 33% more requests received than in 2005, indicating that interest in this assistance from the EMEA remains high.
Leta 2006 je bilo evidentirano nadaljnje povečanje števila zahtevkov za znanstveno svetovanje, pri čemer je bilo prejetih 33 % več zahtevkov kot v letu 2005, kar kaže, da interes za to pomoč EMEA ostaja velik.
On 15 December 2005, the EMEA launched an ‘SME Office' to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs), with the aim of promoting innovation and the development of new human and veterinary medicinal products by SMEs.
EMEA je 15. decembra 2005 ustanovila Urad za mala in srednje velika podjetja, ki mikro, malim in srednje velikim podjetjem nudi finančno in administrativno pomoč ter tako spodbuja inovacije in razvoj novih zdravil za humano in veterinarsko uporabo v teh podjetjih.
Risk-management input was also provided in the early phase of the evaluation of new applications, through the peer-review process at CHMP level.
Vložek v obvladovanje tveganja je bil zagotovljen tudi v začetni fazi vrednotenja novih vlog s postopkom strokovnega pregleda na ravni CHMP.
Total initial notifications received Payable initial notifications received Total initial notices issued
Skupno število prejetih začetnih obvestil Prejeta plačljiva začetna obvestila Skupno število izdanih začetnih obvestil
Two avian-influenza vaccines approved
Dve odobreni cepivi proti aviarni influenci
Of the post-authorisation opinions adopted in 2006 for type-II variations, 79 related to special warnings and precautions for use.
Med mnenji po izdaji dovoljenja, sprejetimi leta 2006 za spremembe tipa II, se jih je 79 nanašalo na posebna opozorila in previdnostne ukrepe za uporabo.
The number of requests is expected to continue to grow as more marketing-authorisation applications are submitted.
Pričakuje se, da bo število zahtevkov še naprej naraščalo, saj se vlaga več vlog za izdajo dovoljenja za promet z zdravilom.
Staff breakdown by nationality, December 2006
Razčlenitev osebja po državljanstvu, december 2006
PRIORITIES IN 2006
PREDNOSTNE NALOGE V LETU 2006
Notably, the Agency finalised safety reviews of:
Zlasti pomembne so naslednje presoje varnosti, ki jih je zaključila Agencija:
EudraCT (database of information on the content, commencement and termination of clinical trials in the EU).
EudraCT (zbirka podatkov o informacijah o vsebini, začetku in zaključku kliničnih preizkušanj v EU).
The EMEA's mission is, in the context of a continuing globalisation, to protect and promote public and animal health by:
Glede na nenehno globalizacijo je poslanstvo EMEA varovati in spodbujati zdravje ljudi in živali z:
New medicinal products (non-orphan)
Nova zdravila (ki niso zdravila sirote)
2.2 Scientific advice and protocol assistance Number of requests for scientific advice continues to rise
2.2 Znanstveno svetovanje in pomoč pri protokolu Število zahtevkov za znanstveno svetovanje še naprej narašča
In addition to the good performance in core operational areas, the EMEA also made a strong contribution to a number of important European public-health initiatives, such as pandemic-influenza preparedness, the European paediatric initiative, the European risk-management strategy, provision of better information for patients, and tackling antimicrobial resistance to veterinary medicines in foodproducing animals.
Poleg dobre učinkovitosti na ključnih operativnih področjih je EMEA bistveno prispevala tudi k številnim pomembnim evropskim pobudam javnega zdravja, kot so pripravljenost na pandemijo influence, evropska pediatrična pobuda, evropska strategija obvladovanja tveganja, zagotavljanje boljših informacij za bolnike in obravnavanje protimikrobne odpornosti na veterinarska zdravila pri živalih, namenjenih proizvodnji hrane.
There were more positive opinions in favour of new medicines for human use than in any previous year, contributing to the availability of 51 new medicines, 11 of which are intended for the treatment of rare diseases.
izdanih je bilo več pozitivnih mnenj za nova zdravila za uporabo v humani medicini kot v prejšnjih letih, tako da smo dobili na voljo 51 novih zdravil, izmed katerih jih je 11 namenjenih zdravljenju redkih bolezni;
All variations concerning immunologicals related to quality changes.
Vse spremembe v zvezi z imunološkimi zdravili so se nanašale na spremembe kakovosti.
One medicinal oxygen intended for oxygen supplementation and as a carrier gas during inhalation anaesthesia.
medicinski kisik, za dodajanje kisika in kot nosilni plin med inhalacijsko anestezijo;
Applications processed more quickly
Vloge hitreje obdelane
The Committee for Medicinal Products for Veterinary Use (CVMP) finalised guidelines for quality-, safety- and efficacy-testing of such products, and published for consultation a similar guideline regarding immunological products.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je dokončal smernice za preizkušanje kakovosti, varnosti in učinkovitosti takih proizvodov in podobne smernice v zvezi z imunološkimi proizvodi objavil za namene posvetovanje.
Areas relating to veterinary medicines included the establishment of acceptable daily intakes for the purpose of setting maximum residue limits and withdrawal periods, and efficacy of veterinary medicinal products.
Področja, ki so se nanašala na veterinarska zdravila, so vključevala opredelitev sprejemljivih dnevnih vnosov za namen določitve najvišjih mejnih vrednosti ostankov in karence ter učinkovitost veterinarskih zdravil.
The PCWP will build on the work already undertaken by the former EMEA/CHMP Working Group with Patients' and Consumers' Organisations.
PCWP se bo opirala na delo, ki ga je že opravila nekdanja delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov in potrošnikov.
Commission decisions
Odločbe Komisije
Sixty percent of orphan products designated in 2006 were for conditions that affect children, including 14% intended exclusively for paediatric use.
Leta 2006 je bilo šestdeset odstotkov zdravil, določenih za zdravila sirote, namenjenih za bolezni, ki prizadenejo otroke, vključno s 14 % zdravil, namenjenih izključno za pediatrično uporabo.
1.6 Pandemic-influenza preparedness
1.6 Pripravljenost na pandemijo influence
The core system was in testing as at the end of 2006.
Temeljni sistem je bil konec leta 2006 v postopku preizkušanja.
The European Medicines Agency in 2006
Evropska agencija za zdravila v letu 2006
More scientific advice and protocol assistance was provided in relation to gene and cell-therapy products than in previous years, reflecting progress made in the field.
V primerjavi s prejšnjimi leti je bilo zagotovljeno več znanstvenega svetovanja in pomoči pri protokolu v zvezi s proizvodi za gensko in celično zdravljenje, kar izraža napredek, ki je bil dosežen na tem področju.
A mock-up vaccine is not intended for use outside a declared pandemic-influenza situation, but can be used to speed up the availability of a final vaccine in the event of a pandemic, once the pandemic strain has been identified.
Modelno cepivo ni namenjeno za uporabo izven razglašenih razmer pandemije influence, vendar ga je mogoče uporabljati za pospešitev razpoložljivosti končnega cepiva v primeru pandemije po identifikaciji pandemičnega seva.
The same applies to all human medicines intended for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative disorders and for all designated orphan medicines intended for the treatment of rare diseases.
Isto velja za vsa zdravila za uporabo v humani medicini, namenjena zdravljenju HIV/AIDS, raka, sladkorne bolezni, nevrodegenerativnih obolenj, in za zdravila sirote, namenjena zdravljenju redkih bolezni.
Actual and estimated numbers of EU and non-EU adversedrug-reaction reports transmitted to the EMEA, 2004-2006
Dejanska in ocenjena števila poročil o neželenih učinkih zdravil iz EU in tistih, ki niso iz EU, predloženih agenciji EMEA v letih 2004-2006
One of the main policy issues tackled by the CVMP during 2006 was limiting the impact on public and animal health of the development of antimicrobial resistance caused by the use of veterinary medicinal products.
Eno izmed glavnih političnih vprašanj, ki jih je obravnaval CVMP v letu 2006, je bilo omejevanje vpliva razvoja protimikrobne odpornosti, ki jo povzroča uporaba veterinarskih zdravil, na zdravje ljudi in živali.
These monographs were released for public consultation prior to being finalised.
Pred dokončnim oblikovanjem so bile te monografije objavljene za namene javnega posvetovanja.
Areas covered relating to medicines for human use included the use of biomarkers in medicines development, slowing the progression of neurodegenerative diseases, investigation of medicinal products in children and neonates, and obesity in children.
Obravnavana področja, povezana z zdravili za uporabo v humani medicini, so vključevala uporabo biomarkerjev pri razvoju zdravil, upočasnitev napredovanja nevrodegenerativnih bolezni, preiskovanje zdravil pri otrocih in novorojenčkih ter debelost pri otrocih.
** A new method has been used as of 2006 to present the number of ICSRs received/expected over time.
** Od leta 2006 se uporablja nova metoda za predstavitev prejetega/pričakovanega števila varnostnih poročil o posameznih primerih v določenem času.
Routes for authorisation of medicinal products in the European system:
Postopki za izdajo dovoljenja za promet z zdravilom v evropskem sistemu:
Further progress was made with regard to signal-detection in EudraVigilance through: implementing a new data-analysis system; drafting guidance on the use of statistical signal-detection methods in the data-analysis system; and initiatives undertaken to address identified problems in relation to compliance with expedited reporting and the quality of the submitted data.
Dosežen je bil dodatni napredek pri izvajanju EudraVigilance v zvezi z odkrivanjem signalov prek: izvajanja novega sistema za analiziranje podatkov, priprave smernic o uporabi statističnih metod za odkrivanje signalov v sistemu za analiziranje podatkov in pobud, sproženih za obravnavo opredeljenih težav v zvezi s pospešenim poročanjem in kakovostjo predloženih podatkov.
In 2006, the EMEA received and validated 3 new applications for maximum residue limits (MRLs)the same number as in 2005, and 2 fewer than were forecast for the year.
Leta 2006 je EMEA prejela in potrdila tri nove vloge za najvišje mejne vrednosti ostankov (maximum residue limits - MRL), kar je enako kot leta 2005, in dve vlogi manj, kot sta bili predvideni za zadevno leto.
Positive opinions
Pozitivna mnenja
After consulting its stakeholders, the EMEA put in place procedures to publish information on the withdrawal of applications prior to opinion and on the refusal of marketing authorisations.
EMEA je po posvetovanju z zainteresiranimi stranmi vzpostavila postopke za objavljanje informacij o umiku vlog pred sprejetjem mnenja in zavrnitvi izdaje dovoljenj za promet z zdravilom.
EudraVigilance and clinical trials
EudraVigilance in klinična preizkušanja
The CHMP concluded that the benefits associated with the use of these dermatological medicinal products outweigh the risks, but that they should be used with greater caution in order to reduce potential risks of skin cancer and lymphoma as far as possible.
CHMP je sklenil, da koristi, povezane z uporabo teh dermatoloških zdravil, prevladajo nad tveganji, vendar je treba izdelke uporabljati previdneje, da se čim bolj zmanjšajo morebitna tveganja za nastanek kožnega raka in limfoma.
Six related to safety issues or benefit/risk evaluation, of which 3 were for pharmaceuticals and 3 were for vaccines.
Šest se jih je nanašalo na vprašanja varnosti ali presojo koristi in tveganja, od tega so se tri nanašale na farmacevstke izdelke in tri na cepiva.
In the veterinary sphere, the EMEA held a very successful Infoday with IFAH-Europe, in November, at which a number of topics were intensely debated, including benefit-risk assessment, user-safety guidelines and environmental-risk assessment.
Na veterinarskem področju je EMEA novembra organizirala zelo uspešen informativni dan z IFAHEvropa, na katerem so intenzivno razpravljali o številnih temah, vključno z oceno koristi in tveganja, smernicami za varnost potrošnikov in oceno okoljskega tveganja.
In order to further progress the direct electronic reporting of adverse reactions into the EudraVigilance Veterinary database, a simplified electronic reporting tool was made available, designed particularly for use by smaller companies in the veterinary industry.
Za dosego nadaljnega napredka pri neposrednem elektronskem poročanju o neželenih učinkih v zbirko veterinarskih podatkov EudraVigilance je bilo dano na voljo poenostavljeno poročevalsko orodje, ki je bilo oblikovano predvsem za uporabo manjših podjetij v veterinarski industriji.
Marked increase in expedited reporting of suspected adverse reactions
Opazno povečanje pospešenega poročanja o sumih na neželene učinke
Opinions for extrapolations
Mnenja za ekstrapolacije
EudraVigilance (web-based information system to support the pharmacovigilance obligations laid down by Community legislation).
EudraVigilance (spletni informacijski sistem za podpiranje obveznosti farmakovigilance, ki jih določa zakonodaja Skupnosti).
Use of special authorisation procedures
Uporaba posebnih postopkov za izdajo dovoljenja
Preparing for the establishment of the European Network of Centres of Pharmacoepidemiology and Pharmacovigilance (ENCePP) - a network of academic centres for intensive drug monitoring.
Priprave na vzpostavitev evropske mreže centrov za farmakoepidemiologijo in farmakovigilanco (European Network of Centres of Pharmacoepidemiology and Pharmacovigilance - ENCePP)mreže akademskih centrov za intenzivno spremljanje drog.
A total of 257 scientific-advice, protocol-assistance and follow-up requests were finalised in 2006, compared to 191 in 2005.
Leta 2006 je bilo zaključenih skupaj 257 zahtevkov za znanstveno svetovanje, pomoč pri protokolu in spremljanje v primerjavi s 191 zahtevki v letu 2005.
Negative opinions
Negativna mnenja
Opinions adopted in 2006
Mnenja, sprejeta leta 2006
The cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) stemming from new clinical and pharmacoepidemiological study data.
kardiovaskularne varnosti neselektivnih nesteroidnih protivnetnih zdravil (NSAID), ki izhaja iz novih podatkov iz kliničnih in farmakoepidemioloških študij.
The marketing-authorisation holder and the manufacturer are currently undertaking an extensive corrective-action plan to restore GMP compliance at the site of manufacture, and the matter is under close monitoring by the CHMP.
Imetnik dovoljenja za promet z zdravilom in proizvajalec trenutno izvajata obsežen načrt korektivnega ukrepanja za ponovno vzpostavitev skladnosti z dobro proizvodno prakso na kraju proizvodnje, zadevo pa podrobno spremlja CHMP.
The small number of new MRL applications is consistent with the comparatively greater interest currently seen for the development of new veterinary medicines for companion animals than for food-producing animals.
Majhno število novih vlog za najvišje mejne vrednosti ostankov je skladno z razmeroma večjim interesom, ki ga trenutno opazimo za razvoj novih veterinarskih zdravil za hišne živali in ne živali, namenjene proizvodnji hrane.
In addition, the Agency made proposals for topics of public-health interest, such as pharmacovigilance, to be included in the project.
Agencija je poleg tega pripravila predloge za teme, ki jih je treba vključiti v projekt in so v interesu javnega zdravja, kot je farmakovigilanca.
All applications for new MRLs and for extension or modification of existing MRLs were processed within the 120-day legal timeframe.
Vse vloge za nove najvišje mejne vrednosti ostankov in za razširitev ali spremembo obstoječih najvišjih mejnih vrednosti ostankov so bile obdelane v 120-dnevnem zakonskem obdobju.