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
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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.