Iyo FDA yakapa chiziviso chine musoro unoti "kunyoreswa kwechishandiso uye runyorwa" pawebhusaiti yayo yepamutemo musi wa23 Chikumi, iyo yakasimbisa kuti:

FDA haiburitse Zvitupa zveKunyoresa kune zvivakwa zvemidziyo yekurapa.FDA haibvumire kunyoreswa uye kunyorwa
ruzivo rwemafemu akanyoresa uye akanyorwa.Kunyoresa uye Kunyorwa hakurevi kubvumidzwa kana kubvumidzwa kwekambani
kana midziyo yavo.

Nyaya dzatinoda kutarisisa mukunyoresa kweFDA ndedzinotevera:
Mubvunzo wekutanga: ndeipi sangano rakapa FDA chitupa?

A: hapana chitupa chekunyoresa FDA.Kana chigadzirwa chakanyoreswa neFDA, nhamba yekunyoresa ichawanikwa.FDA ichapa munyoreri tsamba yekupindura (yakasainwa nemukuru weFDA), asi hapana chitupa cheFDA.

Kuziviswa kweFDA kwechiziviso chakadaro panguva ino chiyeuchidzo chakasimba!Nekuda kwekuvandudzwa kwemazuva ano kwedenda muUnited States, kudiwa kwezvigadzirwa zvekudzivirira chirwere chekurapa zvinotengeswa kuUnited States kwawedzera zvakanyanya, uye kudiwa kwekunyoreswa kunze kwenyika kwawedzerawo.

Kana mamwe mabhizinesi achitevedzera FDA kuti ape zvitupa kune vagadziri, mamwe mabhizinesi ekugovera anogona kuwana emanyepo "FDA zvitupa" pakubvunza vagadziri.
Mubvunzo wechipiri: FDA inoda marabhoritari yakasimbiswa here?

A: FDA isangano rekuchengetedza mutemo, kwete sangano rebasa.Kana mumwe munhu akati irabhoritari yeFDA certification, vanenge vachirasisa vatengi, nekuti iyo FDA haina basa reveruzhinji.

Zvepabonde certification agency uye marabhoritari, hapana inonzi "yakatemerwa marabhoritari".Semubatanidzwa wezvemitemo wezvemitemo, FDA haifanirwe kuita zvinhu zvakaita sekuve mutambi nemumhanyi.FDA inongoedza sevhisi

Hunhu hweGMP hwerabhoritari huchazivikanwa, uye uyo anokodzera achapihwa chitupa, asi "hachizodomwa" kana kukurudzirwa kune veruzhinji.
Mubvunzo 3: kunyoreswa kweFDA kunoda mumiriri weUS?

A: Ehe, bhizinesi rinofanirwa kugadza mugari weUS (kambani / Sangano) semumiriri waro painonyoresa neFDA.Mumiririri ane basa rekuita masevhisi ari muUnited States, inova midhiya yekubata FDA neanonyorera.

Kukanganisa kwakajairika mukunyoresa kweFDA

1. Kunyoreswa kweFDA kwakasiyana neEC certification.Yayo certification modhi yakasiyana neyeEC ​​certification chigadzirwa chekuyedza + yekuzivisa chitupa modhi.Kunyoreswa kweFDA kunotora nzira yekuzivisa yekuvimbika, kureva kuti, une kutenda kwakanaka kwekuzivisa maitiro kune zvako zvigadzirwa.

Zvinoenderana neakakodzera zviyero uye kuchengetedza zvinodiwa, uye yakanyoreswa muUS Federal webhusaiti, kana paine tsaona nechigadzirwa, saka inofanirwa kutakura mutoro unowirirana.Naizvozvo, FDA kunyoreswa kwezvizhinji zvigadzirwa, hapana kutumira sampuli bvunzo

Uye chirevo chechitupa.

2. Nguva yechokwadi yekunyoreswa kweFDA: Kunyoreswa kweFDA kunoshanda kwegore rimwe.Kana inopfuura gore, inoda kuendeswa zvakare kuti inyoreswe, uye mari yegore inobatanidzwa inoda kubhadharwa zvakare.

3. Ko FDA yakanyoreswa nechitupa here?

Muchokwadi, hapana chitupa chekunyoreswa kweFDA.Kana chigadzirwa chakanyoreswa neFDA, nhamba yekunyoresa ichawanikwa.FDA ichapa munyoreri tsamba yekupindura (yakasainwa nemukuru weFDA), asi hapana chitupa cheFDA.

Chitupa chatinowanzo kuona chinopihwa neanomiririra agency (registration agency) kumugadziri kuratidza kuti abatsira mugadziri kupedzisa "kunyoreswa kwenzvimbo yekugadzira uye kunyoreswa kwemhando yechigadzirwa" inodiwa neFDA.

(kunyoreswa kwekutanga uye runyorwa rwechishandiso), mucherechedzo wakapedzwa ndewekubatsira mugadziri kuwana iyo FDA nhamba yekunyoresa.

Zvinoenderana neakasiyana mazinga enjodzi, FDA inokamura michina yekurapa muzvikamu zvitatu (I, II, III), uye kirasi III ine yakanyanya njodzi.

FDA yakatsanangura zvakajeka kurongeka kwechigadzirwa uye manejimendi zvinodiwa kune yega yega mudziyo wekurapa.Parizvino, kune anopfuura 1700 marudzi ezvokurapa mudziyo catalogue.Kana chero mudziyo wekurapa uchida kupinda mumusika weUS, unofanirwa kutanga wajekesa kupatsanurwa uye manejimendi zvinodiwa zvezvigadzirwa zvakanyorerwa kushambadzira.

Mushure mekujekesa ruzivo rwuri pamusoro, bhizinesi rinogona kutanga kugadzirira zvakakosha zvekushandisa, uye kuzivisa kune FDA maererano nemamwe maitiro ekuwana mvumo.Kune chero chigadzirwa, mabhizinesi anofanirwa kunyoresa uye kunyora zvigadzirwa.

Kune zvigadzirwa zvekirasi I (accounting ye47%), iyo general control inoshandiswa.Zvizhinji zvezvigadzirwa zvinongoda kunyoreswa, kunyorwa uye kuisirwa zviyero zveGMP, uye zvigadzirwa zvinogona kupinda mumusika weUS (zvishoma kwazvo zvakabatana neGMP)

Nhamba shoma shoma yezvigadzirwa zvakachengetwa zvinoda kuendesa 510 (k) application kuFDA, iyo PMN (premarket notification));

Kune zvigadzirwa zvekirasi II (accounting ye46%), kutonga kwakakosha kunoitwa.Mushure mekunyoresa uye kunyorwa, mabhizinesi anofanirwa kuita GMP uye kuendesa 510 (k) application (zvishoma zvigadzirwa zviri 510 (k) kuregererwa);

Kune zvigadzirwa zvekirasi III (anenge 7%), rezinesi rekutanga rekushambadzira rinoitwa.Mushure mekunyoresa uye kunyorwa, mabhizinesi anofanirwa kuita GMP uye kuendesa PMA (premarket application) application kuFDA (Chikamu III)

PMN).

Zvezvigadzirwa zvekirasi I, mushure mekunge bhizinesi raendesa ruzivo rwakakodzera kuFDA, FDA inongoita chiziviso, uye hapana chitupa chakakodzera chinopihwa kune bhizinesi;yekirasi II uye III zvishandiso, bhizinesi rinofanira kuendesa PMN kana PMA, uye FDA inoda

Ipa bhizinesi tsamba yemvumo yekuwana musika, kureva kuti, bvumidza bhizinesi kuti ritengese zvigadzirwa zvaro zvakanangana nemusika wemidziyo yekurapa weUS muzita rayo.

Kana kuenda kune bhizinesi rekuongorora GMP mukuita kwekunyorera kunosarudzwa neFDA zvinoenderana nedanho renjodzi yechigadzirwa, zvinodiwa zvekutonga uye mhinduro yemusika uye zvimwe zvinhu zvakazara.

Kubva pane zviri pamusoro, tinogona kuona kuti zvizhinji zvezvigadzirwa zvinogona kuwana FDA certification mushure mekunyoresa, kunyorwa kwechigadzirwa uye kuita kweGMP yemidziyo yekurapa, kana kutumira kwe510 (k) application.

Maitiro ekutarisa kana chigadzirwa chakanyorwa neFDA kana kunyoreswa mu510k?

Iyo chete nzira ine mvumo: tarisa pane iyo FDA webhusaiti