Vakuru veEU vanobvuma matanho matsva ekutsigira kuwanikwa kwemishonga ye#COVID-19 denda #EMA

Kuenderera mberi kwekuwanikwa kwemishonga, kunyanya iyo inoshandiswa kune varwere vane COVID-19, ndeyekunetsa kwakanyanya kune EMA pamwe nevanodyidzana nayo muEuropean mishonga inodzora network nekuda kwenjodzi yekurapa yaunzwa nedenda. Zviremera zveEU saka zviri kuisa mamwe matanho ekudzikamisa kukonzeresa denda pakutengesa kwemishonga nenzira yakarongeka.

Huwandu hwekushomeka kwemishonga hwakawedzera mumakore mashoma apfuura uye nyaya iri kuwedzera mudenda iri nezvinhu zvakawanda zvakasiyana, semuenzaniso kuvharika mumafekitori nekuda kwekuvharirwa, nyaya dzezvirongwa zvinokonzerwa nekuvharwa kwemiganhu, kurambidzwa kunze kwenyika, kuvharika munyika dzechitatu dzinopa mishonga. kuEU, yakawedzera kudiwa nekuda kwekurapwa kwevarwere veCCIDID-19, kuunganidzwa mune zvimwe zvipatara, asiwo kuunganidzwa kwemunhu nevagari pamwe nenyika dzeEU. Kudzivirira kushomeka nekuda kwekuunganidza, dzimwe nyika dzenhengo dzakatemera zvirambidzo pahuwandu hwemapakiti anogona kunyorerwa varwere kana kutengwa nevagari.

Kubatsira kudzikisira kukanganiswa kwekupa, EU Executive Steering Boka paKushomeka kweMishonga Kunokonzereswa neZviitiko Zvikuru, iyo inopa hutungamiriri hwekuita nekukurumidzira uye kurongeka pakushomeka mukati meEU mudenda iri, parizvino iri kumisa, neindasitiri yemishonga, hurongwa. , iyo i-SPOC (industry single point of contact) system, kukurumidza-track kuwirirana pane kushomeka pakati peindasitiri neEU Executive Steering Group.

Nehurongwa uhu, kambani yega yega yemishonga inozivisa zvakananga kuEMA, ese emishonga yakatenderwa nepakati uye yakatenderwa nyika, kushomeka kuri kutarisirwa kana kushomeka kwazvino kwemishonga yakakosha inoshandiswa mumamiriro ezvinhu eCCIDID-19. Zvinofanira kusimbiswa kuti, pamwe chete, makambani aya acharamba achimhan'ara kushomeka kwakadai kuvakuru venyika vane hunyanzvi.

Iyo i-SPOC sisitimu, yakafanana neyeimwe nzvimbo yekuonana (SPOC) network iyo yakavambwa muna 2019 pakati peEMA nevatungamiriri venyika vane masimba kuti vagovane ruzivo nezvekushomeka kwemishonga, yakavakirwa pakugadzwa kwei-SPOC mu. kambani yega yega yemishonga, inozopa ruzivo nezve kushomeka kwazvino kana kunofungidzirwa kwemishonga ine chekuita neCCIDID-19 kuEMA. Muchina mutsva uyu unobvumidza kutariswa kuri nani kwezvinhu zvirikuenderera mberi zvisineyi negwara rerezinesi uye nekukasira kuyerera kweruzivo neindasitiri yemishonga nechinangwa chekudzikisa uye, kana zvichibvira, kudzivirira kushomeka mumamiriro emishonga yeCOVID-19.

Mumamiriro ezvinhu edenda, EMA nenetiweki yeEU vari kufunga matanho ekuderedza senge zviito zvekudzora kutsigira kuwedzera kwekugadzira, semuenzaniso kuburikidza nekumhanyisa kubvumidzwa kwemutsara mutsva wekugadzira kana saiti. Nhaurirano dzirikuenderera mberi neindasitiri yemishonga kuti iwedzere kugadzirwa kwemishonga yese inoshandiswa mumamiriro eCCIDID-19, uye kunyanya yemishonga ingangove panjodzi yekushomeka kwezvekushandisa.

Pamusoro pezvo, EU Executive Steering Group iri kufunga nezvenzvimbo idzo mitemo yekudzora inogona kushandiswa nekushanduka-shanduka panguva yedenda kuchengetedza kupihwa kwemishonga yakakosha.

Kunyange hazvo kushomeka kwemishonga kuchigadziriswa padanho renyika nevakuru venyika vane masimba, EMA yakakumbirwa kuti itore basa remurongi wepamusoro kuti atsigire zviito zvekudzivirira nekutonga kwenhengo dzenhengo panguva iyi yedambudziko rehutano. Urwu rudzi rutsva rwechiito chisingakwanise kushandisa nzira dziripo uye zvinoreva kuti iyo Agency inofanirwa kuisa itsva ad hoc maitiro uye kukoshesa zviwanikwa kune chiitiko ichi. Sangano rave, semuenzaniso, richiunganidza ruzivo kubva kunhengo dzenhengo kuti dzitarise kana kutarisira kushomeka kweEU-level muzvipatara. Yakabatanawo nenyika dzenhengo maererano nekuti kurambidzwa kwekunze kwezvinhu gumi nemana (APIs) kwakapihwa nevakuru veIndia kunokanganisa sei kuwanikwa kwemimwe mishonga munyika dziri nhengo. Pamwe chete nevabatsiri vayo mune network yekutonga, EMA iri kutarisa mamiriro ezvinhu zvakanyanya.

EU Executive Steering Group paKushomeka kweMishonga Kunokonzerwa neZviitiko Zvikuru inotungamirwa neEuropean Commission. Nhengo yaro inoumbwa nevamiriri kubva kuEuropean Commission, iyo Heads of Medicines Agencies (HMA), EMA, masachigaro emapoka eCoordination for Mutual-recognition uye Decentralized Procedures yemishonga yevanhu neyemhuka (CMDh neCMDv), zvakare. senyanzvi dzekutaura nengozi.
Ruzivo pamusoro pekushaikwa kwemishonga kuri kuramba kuchiitika muEU rinowanikwa mumarejista akakodzera ekushomeka kwenyika uye bhuku rekushomeka kweEMA.