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GMP- A Regulatory Perspective GMP- A Regulatory Perspective

GMP- A Regulatory Perspective - PowerPoint Presentation

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GMP- A Regulatory Perspective - PPT Presentation

GMP A Regulatory Perspective Regulatory Perspective in entering Global Pharma Markets Regulatory Perspective in entering Global Pharma Markets World wide market of pharma products ID: 486294

perspective regulatory pharma global regulatory perspective global pharma markets entering products amp market patents module countries form regulations para

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Slide1

GMP- A Regulatory Perspective

Slide2

GMP- A Regulatory Perspective

Regulatory Perspective in entering

Global

Pharma

MarketsSlide3

Regulatory Perspective in entering

Global

Pharma

Markets

World wide market of

pharma

products:

1 Trillion $. Growth is 5-7 %

Out of this about 40% is in North America. Slide4

Regulatory Perspective in entering

Global

Pharma

Markets

Global

Pharma

Market : mainly divided in 2

(basis of Economy & regulatory controls)

Regulated market(countries)

(

US,EU,Japan

&

Australia,Newzeland

)

Emergent markets (countries) . (Rest of world)Slide5

Regulatory Perspective in entering

Global

Pharma

Markets

Countries with out established systems for controls:

WHO Regulations: For Health matters

&

WTO regulations : For Trade RegulationsSlide6

Regulatory Perspective in entering

Global

Pharma

Markets

For New organization:

Type of products to be exported:

a. General case

b. Products using impermeable containers

c. Products using semi-permeable containers

d. Products require refrigeration

e. Stored in freezer.Slide7

Regulatory Perspective in entering

Global

Pharma

Markets

Select Area for use of products.(intended export)

Zone I : Temperate

Zone II : Subtropical(possible high humidity)

Zone III: Hot/Dry

Zone IV: Hot/HumidSlide8

Regulatory Perspective in entering

Global

Pharma

Markets

Statement of labeling :

Based on stability studies it should be very specific for storage conditions.

( terms like ambient temperature/ room temperature not to be used)

Other details according to local legislations in addition to mfg & expiry details.Slide9

Regulatory Perspective in entering

Global

Pharma

Markets

For US : largest market and most regulated.

3 categories:

NDA

Abbreviated NDA

Mix of both i.e. 505(b) 2

Birth of Generic industry in US 1984: Drug price competition & patent term restoration act.Slide10

Regulatory Perspective in entering

Global

Pharma

Markets

Different types of ANDAs

Para. I : Products with no patent information

Para II: Products whose patents expired.

Para III: Patents are available but products will be marketed after expiry of products.

Para IV: Patents are valid, but new product does not infringe those patents or applicant invalidates the granted patentsSlide11

Regulatory Perspective in entering

Global

Pharma

Markets

CANADA

NDS New Drug Submission

ANDS for generic products

Submission to Health Products & Food Branch

(typical scientific information about safety, efficacy and quality of products)Slide12

Regulatory Perspective in entering

Global

Pharma

Markets

CANADA (

contd

)

Supplemental NDS (SNDS) when there is change in formulation, method or strength or route of administration, labeling or expand the indication.Slide13

Regulatory Perspective in entering

Global

Pharma

Markets

EUROPE (European Economic Area) 27 countries

EMA controls the authorization in EEA

Centralized procedure for products of biotechnological process, new molecules for cancer, aids, diabetes, viral diseases, orphan drugs, auto immune diseases, new radiopharmaceutical active substance.Slide14

Regulatory Perspective in entering

Global

Pharma

Markets

EUROPE (

contd

)

Decentralized procedure for drugs which are out of scope of centralized procure.

Mutual recognition procedure is adopted if

applicant

wants

to extend his market after receiving marketing authorization in one member state.

National marketing authorization is used my member states for products out of mandatory centralized procedures.Slide15

Regulatory Perspective in entering

Global

Pharma

Markets

JAPAN

Second largest market next to US

11% of global sales.

Pharmaceutical and Medical Devices Agency under Ministry of Health,

labour

& welfare handles approvals, licensing and post marketing safety.Slide16

Regulatory Perspective in entering

Global

Pharma

Markets

JAPAN (

contd

)

J-NDA & J-ANDA are submitted to PMDA.

PMDA review technical data , consults various councils and refers to MHLW for evaluation for medical needs, social issues in addition to scientific review for final approvals.Slide17

Regulatory Perspective in entering

Global

Pharma

Markets

Emerging nations: Rest of the World

Asia Pacific, Latin America, Eastern Europe, Africa & Gulf countries. This market is growing @ more than 10%.

Environment is regulated through ASEAN( Association of Southeast Asian Nations) and GCC(Gulf Cooperation Council).Slide18

Regulatory Perspective in entering

Global

Pharma

Markets

Emerging nations: Rest of the World(

contd

)

Application is made through ASEAN Common Technical Dossier(ACTD) and same document can be used for non member nations with minor modifications.Slide19

Regulatory Perspective in entering

Global

Pharma

Markets

Other factors:

Patent Scenario &

Exclusivities: Data exclusivity and other exclusivities are available to promote the company engaged in incremental innovations.Slide20

Regulatory Perspective in entering

Global

Pharma

Markets

Components of Regulatory Filing:

As per ICH guidelines through common Technical Documents (CTD)in five modules(1-5)

Module 1: Regional & administrative details

Module 2: Overall summary

Module 3: Quality

Module 4: Safety

Module 5: EfficacySlide21

Regulatory Perspective in entering

Global

Pharma

Markets

Indian regulations:

India: leading supplier of generic drugs & API

Regulatory requirements as per Drugs & Cosmetics Act

Licenses: Test License: Form 29

Import License: Form 10 & form 11

NOC for BE

Manufacturing License: Form 25/ Form 28Slide22

Regulatory Perspective in entering

Global

Pharma

Markets

Thanks

for

patient

hearing.