UNIT 2 Regulatory approval process and Regulatory authority and agency.pdf

Unit 2

Regulatory Approval Process
Approval processes and timelines involved in Investigational New Drug (IND), New
Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an
approved NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia,
Japan, Canada (Organization structure and types of applications)

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MB mon categories —
y

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288 a

ainical Protocol and Investigate Information.

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5. F1 Toppmval process) dor Ip > _

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ies to FDA O
4 a seccióng. the Application , FoA tem
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à with in [so Paya] nf te IND sealing Date,
E

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s

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=

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+

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cr P*

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tials

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tal uN
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orient Jong seme Re

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=

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demal fino] "step a Drug sponser taken
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and ng Adeinistration [CEDAJ) to ger
approval for mangeting a Ned ug”
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iS used dr. Haan Ter Cetinical iets)
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y
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RR DR

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ong Se 25 sk 4, fective
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ie

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Aug ane Appropriate

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Approved pA

O [wo Require ment] +

Car E mar d apple a,

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Antigictic__ Application

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mé

10. NOA technical _ seclions —=
Pbineviaked New mg Appücohon

BO

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Submitted Ar Appel À Diag fr
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natu of the Pug, the LOA mutt
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—| Y -the__ sponser. ding the product feseanch &
Development

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(Bean) copy > This _is_a_Compichensve py of
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nm te Rai copy

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11. ©

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Tanken: jaenvification an

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filed in Me form of tbe or graph.
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and 200. fages.
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—- TAB cole mini Summary.

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12. ©

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pres substance, Physicel and chemical
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ng Product — Tt incude info about

U Composition X Dosage firm

Name € Addiess “of Manufackutet
“ container & close systen

La Stability

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JA indudes =

Pharmadogical studies
Acute Hoxicóy _Shudies
Muth Pose toxiaty studies
Mutggenicty studies.
Apme studies -

Human Pharmacokinetic Summary
Micrrhiological Summary.

13. > ®

JA) na Technical section — Mis imcuide rich

ae | description of Following :—

| chemsty_, — manufacturing and onbab

Ü) Non-clinical _Manma cology and. Tokivelogy -

di. Human p'ækinetics and Bio availability Section
dy) midbiologs ——

&). dinical_ Dala Section .

Qi, Samples. Methods validation and labeling

cb @ase__ Report Forms _& _ tabulation. “m _
quid, Paknt infos

“ A
[NDA Rena») Process —>- Élimetine)” et mares

NDA

4 send
EDA] Beta.
\

FDA Review team Decide-
q —— ai

Vag Noa nor
complete then.

af MA is complete - 4
ga team Can.

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mans] to make decision . ES
to apre the Drug, CA
= =<

D | (fpprval pmcess) involved in [NDA] +

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14. 3 Approval nes involved Im

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[mg stm] a
Mi :
[NAT I
applet Flanel i
cn J Refuse +
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Lang — int —
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rang} ==
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meeting — y
[_Reies camp lente]
LE Acceptahe, | y A
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| >
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ey ae
InpA | 15
L Approve] te
sutistas

~ Record

15. o [Ama] 5
CAbbuiated Nes mug Applicaton]
Y genetic pgs
rs ne er à =

An-_abbicviated
“yew png Application contain Data _ which. is:
submitted tb MA for the iuieo and - Pokntial
oma a genetic Pig Prnduct:

caos

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ana market the genode Drug. product
i =
to provide a safe, effective, lower ost Alteınakye|
ue pe Hand (Name medication

aa

>
zu er
RDA =
submission Loges Patent res ehren
Le y _ Fin PARK
+ PRA-IL Patent wall expire on}
| Patent wall invalid: | fie =

or not be infringed |
sy he Duy Ar which Approval,
I °9 one. |

O Ta. À foma I fila Foc m

of generic is Made ten —
innoyakır has fee a requises information —
in the ex Orange Book =

16. OR

A-T|- A al Aung is Made: wh
©. [ram = “il en = ar ea
O. Traga -ml- :

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te generic Pa

E Drugs Pate

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believes ls: preauct
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Ich
ls made then ne aplica
docs net finge on

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Dot valid

de A Federal

Regulation —?

CL CER au) > Application to FDA appraial to
Market a - Neo Drug or AntiBiotic
Drug

+. [21 CFR 3201 — Bicaveltabivity
Hquitemen$

CR gi) = po me =
„office of generis ng [om] —

and Bloequalaleace:

Stongty
eo encourage ° supmisson of. =
Bioequivelence, chemis; ori tabelting Cordon

oP “the Application in” electronic format

17. ©

5 Tome and (content! of AMA =

3 Te abbraiaked application must be Submitted mn
coped 2
mec OPI > Archival copy
> Review. copy

field Ry
3 An archived Py must include — the foot} -
7 Application fam - U labeuing
sie of content ve chemistry, manufactuicl
U Basis for AnpA submission & orm! =
Y condition of: use vu samples’ E
Y four of Administalión © Pakent cerfticaticn
Y Dosage fon Shengin- other info
U Bicaveilability 8 Hioequimalence.

O [ppal focas A _Anpal 7

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- rm I —
Peceptable_£ comprete | duel © |
ra EE!
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ñ wee
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18. Bio equivalence | al — Chemisty
e L Mido, labeling
Aceptable | Reit Aeceplabje

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\ +
aca FR App) Une
dein rice inspection | Not Appnwase
se teller
[va
y =
[ANDA Appa] Apprvap

Oentet

fig > Apprval Process of
ANDA.

> imóme]— winin 8 :month of. Submision
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with nto month an EE

he Apprivell_ inspection Required J
© [mk] =;
mw _Chenicad
aly > 5 gas

D, fedialic exclusively — 6 month Akdilionet.

Ail tu dk galego 180 Pays

19. [E 8
— Troay AnoA] —]

TE guiddine — gives _ eiemmendalions te- haklors

Ya

PA and — NPAs] ees
vb
who intend. to mate Post_ approved, ek
1 oczendance with section E see
Raeral Pod + Drug & Cosmetic Act and 34-40
CAR + ET
5 4 fps) tne prtvious guidance Provided re
open ne Same Lilien — ap. 839. —
V Recommendatioid ae provided for Post _Approval -
changes In = =
components and. cmparhon- Sn
—__Monufachuing SH Multiple Related
A_ specications unge. —
container Closure System i=
Labeling En

_miseuaneous Change 3

D CRantig_œegoial > The guidance provides 4 Tr
2 ue Fitowing Reporting Gutpgones d he-
tod appmal changes & ng Cap

© maja change
© _ moderate change
D. F a"
P a spine kqubing the submission oT
Lo chape being effected 30
PO the change _setuiving “the Submission.
cf _suppliment-s changed peing Affeeted

as Gange

20. @ |

© | major changel > A major Change is ome
i thot had a signif cant _Polentiag
— to have an undalrable influence

To
he eto shength , Quality , £ Rarity of
Pra: =
= Tien af = safety ar effectiveness of the
Product

Filed ‘M Prior Approval Supplement-

© Por appeal supplement >> An applicant may
request that FA acceelede Its“
Gnsideration cf PA Supplement for Public

health. seasons

C eg: og orage)
©) [moderate change] > A moderate unge is"

one that has a modest Risk
affecting the identity, Quality, Purity
or Potency cf Pra … Pmduct .

>. Tree factors may be Related to ne medicine's
salty or _ effectiveness.

Epi 1 There ane two types of modenelt-

change
change Reno — Ca chénge Requisiy
nn De a the submission

dione a efleded, m Su ek

21. Ol {Minor changel > À minor a
Fr
“het has mirimal oo =
have an. Adverse effet m the
y

bang Quality, Put shengin or opi
3 poten

of Eng Product 4
== ==
58 6 age in component "= Cost Appa
nr

manufactunng site: © me a

@ cda pres. E — JE Ave

T
Ver Dra,
© Cainer closure sun 2 ET,
| © _labeuins <= -
I! ® Multiple Related chang = ==>
© [agan cempenentl > hagas in conparents

and tampasiticn
being - elfeckeat suppl

t may que a changes-
ment oy an Annual RER

ox not Addressed N thus. guidance Dotumert.
ONDA ANDA)
a But involved m Supac Documents
7 a e _ Changes
© auufaaung sites Jo Ha bug a
to a Mafulaciurng site per an at
; 4 per mus
ecified in ne — appre application
4 be retifes
> Mae site con indude :- we, pus

Manufacture ef focas. Dry Pda

Maktual .

22. @ i

Package ny Product = a
Label Dig Products u
Test component = Drug Produc container _
> usure, Packaging Mateos
> In Docs maledal

Mowutachuin fes) > Me Sadéky and
y — fefeckiveneAs\ of Drug product pepeng
“on __dype manufactuting Process ad the
Changes —Seing _inshbuted “for Drug Put.

seg UOTE Qual, Ari)
|

qe FachorsReiake ui

Sahıy or _eficctivencas a
O [sprificatiml >
specifications
"Te Quality Sander
application “to tema
v Dug Substance
Dg Produc
Rain materiel
Components
_Tn process material
étainer … dose stem & other _e makwiel

{5 Quidance , FDA aehnes

ided in an am

y
used in production (e omg foc
A
{container dosure system | =

23. É ee

The Potential that à chan, aS

@maineı dlosuec system wil have an. ae E

en te Cacntity, IShenginl, Quai), (Puri Ic sic

Meng of mg Ss sky & Peer reg
y

is geleratty depend on Ali :—

Vongs faute of administration

v Pefomance ef container closure system.
vo ligetimood cf merachon Alto te Packaging
Component £ ne Dosage tom. E

€ [Lapeuing] = A chauange in Ds labeling incide
changes in one of the flog —

Y Package Sens
“Package labeling
Container label,

E [Ripe Related chang ca) > Te -invoues various
combination ef Jndividuol changes —
TF Applicant has multiple _Relaked changes that
fau ints different Kémmended parties
Categories ,
PA
O AR

[minor T Annual | up to age WA
Repo Before _ submission

|
AE

24. ©

UT Vena We | Anticipated luuidetne*
| | imaement Petrol p>

[O | moe. cBE-0

| one receipt of |
[oupnisson by FA }

GE - 20° J30 pays Aer
fect on Submision |

Major : Por Appa | up to 6h
supplement | After Subrtission

Ploy a vital vol to meet tie
Requirement _ of
y

legal uceduers lated to Dm
Dorel pment Pas. N countay

Mp

LT

7 uk > Regulatory Agendes and organization

25. [chapter-@ 1
[Regutatoiy ARS any (5)
guate AMES gy

D [Begulatoy —Auttonty | > Me Re
iS an, Organza
Ropmsie Air ll Mg Paget Ma

Required fo ensure the

Lefcacyl ef pag uit, (ER) ana

7 They apédat tc Development and pes i
sé and clkctivepPeduct Amnd the woe?”

— =
om À e
f y Regmatian er PMG
gus, MS _
Pr > {ensece
Authority

Quality, say, chic _

cab] & Mer Rey

— Cay Aa
India Tcoscol* Central Ing
© ae control Ogatzahon.
© sa [DsEpAl : mel
® _ Euwpean union TEMEAL cempon means)
Agences ? Sl
O Ausbatia [ima] cheat n°
‘Asministretion)*
8 3 mw
apan .
©

mul __— |
CANADA [atta el oe
ln

26. e Ro

D [Oveviaol oF query AE]

® 9 Regulatory — Authority of [mai lo=- 7
Tn —india

Here was ne separate Regulahen kr
waishiburion or

Kgulahng the manufachunng
sale of” medical Devices till 18:10.

nd was Passed

Im sto Pug & wsmetic
After Mat different "Reg. arity"
axe were established to ont} 04 Regulation
>. My qe as t= =
7 central png standand Control Organization.
R Toosco| - nn
ED múnistey of health 2 family welfare MHew)
D Mahal phanmacttttie picing- Authority. E
G@ Catral mug sting latoratupj- (> os _

[@sco] +> = ne

Tre Ds is the main fault}
Body tor Regulation cf _ Phanmaceuttcal ..
medical devices and Clinical trials

AS

L

(esto is the National Regulatory Author} ard)
oa India
2 Tt uals under he ministry. d health &
amity wetfore ent of india.
> xs “headquator is located at Neo Delhi |

=> 339 _ staff members
>| costo work wm he wo to fromote_

nanufachwing Practice (amo) À. =

27. q

&

the. coco app
issuan
various Categories A Le a
pu ce à
ey tu und a de nal
id tke —

[ebjectivel > 1
en Promote & Polect Public

¡CATA a a

Goo zonal die! = atta
e) ounliation ge

oe
al Sipe
ray 237]

15555 GA er

sal oa

28. ©. [type of —Appication| — (costo)

] A Appücahon | License
‘Application UN ee ie
through. [throug
© | Snport of war |. .
mg | fom qu fom us
© | Manutachue of
Nao Drug Form yy. | Am Ces:
El | [73
| ® | Permission to =
| wiotake clinica} | form 44 Noe Wo |.
Ez tial
| @ Regitrafion ceutifi_| :
GR for impo | Am 40 | Am 230.
a Oregs into | ui
India |
| Import úcemse fr 1 fom 8: | form 45
Pngs ner] 19
we +

2 [MoH Fwl- Cost of heath X fami
welrane) ~»

© DIE > wre is an AA Hechrical
ist

funded By Ministry of health Rai

wellqie. fr PRomelion oF neath 2

Fania Programmes in County $UGh
ediicection

29. bebe vs

Y

® ION

RMF wur established On march à oH

sit À uovenning Body Members
CIB memben 9 —

chairman: 0) et oficio

vice chaman Cea officio) 9 member er hen)

6 member

1 member secretary Cex officio)

F thew

LOTAB)— (mg technical Advisory. Boand)
& =

‘Advice the govt : on te matter. 2 klakd to

he Drug eo =
3 Lara
Total mener — (©. x =
— ———s, —
oficio, [ueninates | (eecteD
& © E)

30. a

OD [Reguiatony — Autentyl of sitet ele =—
>, Me USFDA (united state Food Crug Administ,
15 man Requtatony Authonty or US _

I lo he oA Good % Png
Se is an agen wath mn

die U55- Department
En

Nenn & human sewices -
STH mist of sx product cenhe, ame resconch
cure on) Too difices
dt has 4 Roles
fi

© to fromote health Gy reviewing dearcch E

approiing new Prducts 2
To ensure food and ugs ax safe an

Propouy Labeled

© To wok with other nadas to "Reduce “he
burden oF Regulation

O To cooperate uh scenic _exfedstand:
consumers

2 a en
AE AAA Gail oe.
«No is Pppoñtkd Sy he fesident and

Y wel By senate

| Forganizahion shuctuel —: Jr involves >

commissioner Rat to Me _secrctogy an
human Sonies - ¿

31. @

Department of heath Pi
Sewces FPA men

| office of the commisionor |

lemnisson_of Rod & |
pui

j Principat Peputyy emmiss} |

Tchic_staft]

it
T— y | y Y an
€ fi center for | cent for ite F
Gobgicol evaluation POS | “waco: Fr
2 paco Rdiokfical dad VAT
= Heath | meaicine
, A =
Centre for | amic
a or
a mon =
atonal vod May | minsnty ell | ofertas
Alten | ? Response 2 health ae
equity gine ©
E Es.
die d do nee
Chick scientist oftice ot ly tie!
y woman health: nan pares
or hol
Cente HA
N salty d_
a Aut”

Ag USFOA organization
Structure -

32. ee

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¡SISI

Te pa has its headquakens in IN Hp,
white Oak, maryland =

me ag also has 223 feld offices ang.

1% taboratomies lotated fhmugnbut the So tue

Me. FPA agency with fhe Pepartment À health |
& human semices Consist of nine Cenhe lever
oganieations £ thirteen _head quaters

YSFPA organization Structure. involves >

me office d the commsionen Cod:

Me cen fr mg evoluation. € Resemch
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cenpe for Biological evaluation £ _Reseanch _ (GER)
centre fur Food. sakty and Applied

fuchition - (EAN)

Me cenhe fur Devices € Radiological health RH)
Me ceñtén for vetermialy medicine. (CUM
National @the fr: “ice Réeonth. (vcr)
Me fic of Récaby Mrair CORA)
Éluacton) >

USFPA is Responsible for froteding

the bic health By Asswing tne safe,
Pay and Secañty of - human €
“Veterniary Dry
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= & =
CRA & Pat Mar emit ¡Rodiadicns

33. 8

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a LTS
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v
mis application is Submitted te FDA to obtain
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fem KBA=3SCH-
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to pm Na Drug helieves hot enough.
aidenee on at og Safety E _Cffectivenscas. —

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supervision and Safety —_menutpting. vf medicines
m Me EU a

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pean Union and _Marmaceutical Ids.

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UK

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SEU DK.

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ot 36 members, appointed 0
act in Public interest

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a i >: fe m ho
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ately So Aue tm staff

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wu Pa ediabic commi tee —
«sir Gmmitee fur __ Advanced, — -henapiéé:

lance fis _manas Commike -

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from _eanly stage of Development —.—— _—

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to
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into _ mantel?

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A

spi submit clinical hay Appúcabion %
ME ompeleat Authority im each member Sa
un Me Gials arc to be conducted |
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i Medicine Pmduct Ec 141/2000
The my ent or Rare Diseases,

the sponser has te file an appication fra
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cede

37. only after Apprval orphan du con be.
manteted

FRegualuny Authority) of Tabla IS

Cua) is the

Tera peutic” wood Administration

Regulater Acunonty of Australia
Final + Me Taie vod _Adminsteaher
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d
d
Heath and Ageing, Responsible for Administerung
he ACT. y
TA came into efed on 15 Rbruayy 1091
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South wales Australia
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monito mg

"ening

Tie Tra is Resamable for Quit set
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medical peices in Australia,

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Market Authori2 afin] Head monet:
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goods fr Areümental _funpose in humans
Dae a a

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De teguary Aumonty of Japan. 15 [MpAl

= —CPanmaceutical medico and medical Peces

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==
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dossiers, eee sewices fox fauve health
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Main fun pose to Botect he fumic health 69,

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= Pam oceutic & medical devices

40. E

Head Quarts of PmpA 8 at tokyo, Japan

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Hoffe
A

of

market in the word,

acid of PmpA.

Review and — Audit For Pug and Medical
Devices .

fost maxtelins salcty operations Fr ngs &
medical devices
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and other inicctious disease

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is CT For, coca ff [chiet Sach

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xe of RAD | dice of medica) peces:

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office À cond ormity Audit”

41. @

© mu > I 6 alo Regulatory Authority oF
Japan
1 was established by merger Ca munisty A

heath 8 wetlanc
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facilities
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felicy planing & evaluation.

ed

42. due

9 |

Type oh Application >

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NPA 2

aameüc Drug Apprwel application

orphan, omg. Application
fon ty Review

two © Appúcadion -

Me ETES Aurhonty of CANADA | ls heat
Canada © Ba 32 =

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Health canada _is_tesponsisie Ar helping Cñadicas
to _mainten and improve inci health

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ohyinady _H was created as he
Department oF health m 10]

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Ctlawa Ontario, Canade

Regulalury Puces fy Pug in canada —
Prectinical studies -
Cinical sty trials
Regulatory Product submission.

43. aa la lols |

ra

Review
L Authoneation
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Post _ Meer Keting

mini:

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investig ation

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Aut Deputy minister / Assodate

Route Peputy Minister

u

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det Nations and | > y
aa Pest management
CRE Regulatory Agency

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ally Branch Regions Bremer.
chief finandal |. office of ane
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legal services ——— corporate

Sewice _ granch .

[= fable he .
Bag À nan,

canadian institues
heath Reseach

tT Patented medicine
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F Assisted Human.
Reproduction.

Fa Iran.

44. |

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