Pharma Regulatory Affairs in Argentina 2013
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Transcript of Pharma Regulatory Affairs in Argentina 2013
Pharma Regulatory Affairs in ArgentinaSteady regulations in a turbulent environment María Inés Guaia
October 2013 - Prague
40 million people
13 million in Buenos Aires and surroundings
30% below poverty line
Services 60%
Industry 30%
Agriculture 10%
$435.6 billion GDP#27 World#3 Latin America
8.8% annual growth rate
#12 World#1 Latin America
Argentina: an emerging economy
HealthCare and Pharma in Argentina
8.5% of GDP in HealthCare
No coverage38%
Social Security 48%
Voluntary insurance
9%
Voluntary + Social security
4%
HealthCare system
Pharma industry revenue: about
$4,000 million / year
More than half of the market is taken by local pharmaceutical companies
Nervous System
Cardiovascular system
Digestive system
Systemic antiinfectious
Antineoplasic and inmunomodulators
Muscle-skeleton aparatus
15.9
14.2
13.8
11.2
11.0
7.7 %
The drug agency in Argentina
National Administration of Drugs, Food and Medical Technology
National Institute of Medicines
(INAME)
National Institute of Food
Direction of Drug Product Evaluation
Direction of Medical Technology
Direction of Planning and Institutional Relations
Direction for Coordination and Administration
Direction of Legal Affairs
Control of sites, processes, activities, technologies: manufacturing, importation, fractioning, marketing
Clinical evaluation
National Regulatory Authority of Regional Reference (PAHO/WHO)
Structuring the submission dossierDifferent cases
Drug registration in Argentina
Lists of countries by sanitary trust level
ANNEX I USA France
Japan United Kingdom
Sweden Netherlands
Switzerland Belgium
Israel Denmark
Canada Spain
Austria Italy
Germany
ANNEX II Australia China
Mexico Luxembourg
Brazil Norway
Cuba New Zealand
Chile
Finland
Hungary
Ireland
High Sanitary Surveillance
Decree 150/1992 and modifications
Drug registration in Argentina
• Product information - name, formula, pharmaceutical form, pharmacologic classification, marketing condition
• Technical information - testing standard, specifications, shelf life, manufacturing method, pharmaceutical equivalençce evidence
• Labeling texts (packaging and leaflets)
• If manufactured in an Annex II country: CPP of origin (marketed)
• GMP from Annex I country or Argentina
DPs manufactured in Argentina or an Annex II country, similar to DPs already registered in Argentina.
DPs manufactured in Argentina, with marketing authorization in an Annex I country, even if ‘novel’*.
‘Article 3’ products
* ‘Novel’ products: there are no similar products registered in Argentina
Timeline for approval: about 12 months
Drug registration in Argentina
• CPP from Annex I country – Marketed status
• Labeling texts (packaging and leaflets)
• Technical information - only upon authority request
DPs with marketing authorization in at least one Annex I country.
‘Article 4’ products
Timeline for approval: about 10 months
= ‘Article 3’ DPs
Drug registration in Argentina
• Product information
• Technical information
• Labeling texts
• If manufactured in an Annex II country: CPP of origin (marketed)
• GMP from Annex I country or Argentina
‘Article 5’ products ‘Novel’* DPs manufactured in Argentina.
‘Novel’* DPs manufactured in an Annex II country.
DPs manufactured in a non-Annex I, non-Annex II country, and not authorized in any Annex I country.
Safety and efficacy data
plusTimeline for approval: not less than 3 years
Biotech registration in Argentina
Regulation: October 2011
• Hemoderivatives• Products obtained with recombinant DNA techniques• Monoclonal antibodies• Biological drugs produced from animal tissues or biologic fluids• Other biological products
Biosimilar/biocomparable drugs
GMP inspections from ANMAT
When?
For DP manufacturing sites when not in Annex I country, and without certificate from Annex I country.
• DP specific
• Agreement with MERCOSUR countries (e.g. ANVISA)
Application for inspection: documents
• Written request• Copy of ANMAT authorization to requestor • Information on manufacturer/s• Site Master File• Site authorization from HA in country in
which it is.• List of pharmaceutical forms manufactured
in site• List of DS manipulated in site• List of pharmaceutical forms by DS to import • Information and documents on third parties
involved in manufacturing or control• Fees
Post-submission actions and life-cycle management
‘First Batch Verification’• Local manufacturing• Importation of drugs Local QC
• New product registration• New concentration of
biologic or small-therapeutic-window APIs
• New pharmaceutical form• Marketing authorization
transfer
Submit form , manufacturing/QC schedule, technical information, pay fee
Marketing Authorization
Positive outcome
ANMAT inspects ANMAT doesn’t inspect
Send manufacturing/QC documents
Renewal of certificate
Documents
• Written request
• Sworn statement – marketed/non marketed status
• Evidence of marketing
• Certified copy of original certificate
• Copy of last approved labeling texts
Every 5 years(within 30 days prior to certificate
expiration date)
Relatively simple procedure
Variations of regulatory impact
Examples:
• Change of excipients• Change of manufacturer or
manufacturer’s name (only for DP)• Change in labeling texts – leaflets
and packaging – including new indications
• Shelf life extension• Change of marketing condition• Marketing authorization transfer• New primary packaging material
Submit documents (very variable requirements)
Wait for approval
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New Opportunities and Challenges
eSubmissions: step by step
2010: ‘depaperization’ projectGoals: better service – efficient administration – lower costs – greater transparency
Currently:• Electronic payment• Digital signature• Clinical studies submissions• Importation authorization requests for dietary
supplements and medical devices• Submissions for registration of cosmetics• NEW! JULY 2013: Adverse reactions
reports (pharmacovigilance)
New OTC labeling regulations
new definitions and guidelines for labeling texts in leaflets and packaging of all OTC drug products
• 2 years for submitting updated texts
• Immediate application for new registrations, variations and change of marketing condition
Information in question formatWhat is…? What is … used for? What warnings are required before/during the use of…? How should I use…? What should I do if…?
Illustrations may be added
for better understanding
Only information relevant to the patient in layman’s terms
Study: Patients had trouble interpreting the content of PILs
February 2012
More new labeling regulations!
new requirement of information on gluten content in leaflets and labeling texts of all drug products
Active lobbying by celiac disease association
May 2013
‘This drug product is gluten-free’
or
‘This drug product contains gluten’
+ analyses to show that products are gluten-free+ GMP certificates to proof no contamination
1 year (from 2nd May 2013) for all oral-dose products to comply
Orphan Drug Regulations
Previously: only special process for importation of drugs for compassionate use
August 2012 regulation for registration of
drugs ‘under special conditions’ Definitions
Requirements
Creation of special committee of evaluation
Orphan Drugs• Low frequency disorders
(<1/2000)• Severe diseases (risk of
incapacity or death)
• Complete information of (at least) early phases of clinical research (preclinical and phases I and/or II) – adapted trials
• Evidence of orphan status
• Plan of efficacy, efficiency and safety monitoring (patient register, prescription/distribution scheme)
• Periodic reports
• Intensive pharmacovigilance
• Informed consent
• Labeling: ‘AUTHORIZED UNDER SPECIAL CONDITIONS’
Thank you! Muchas gracias!
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