drug registration in argentina

Success Strategies for

Product Registration

In Argentina

Case Study:

María Inés GuaiaOctober 2012 - Berlin

Argentina – an emerging economy

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

HealthCare and Pharma in Argentina

8.5% of GDP in HealthCare

No coverage38%

Social Se-curity 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)

Practical advice

How to build a dossier which

will satisfy the authorities

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


• Product information - name, formula, pharmaceutical form, pharmacologic classification, marketing condition

• Technical information - testing standard, specifications, shelf life, manufacturing method, pharmaceutical equivalence evidence

• Labeling texts (packaging and leaflets)

• If manufactured in an Annex II country: CPP of origin

• 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


• 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


• Product information

• Technical information

• Labeling texts

• If manufactured in an Annex II country: CPP of origin

• 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

= ‘Article 3’ DPs

plusTimeline for approval: not less than 3 years

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

‘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

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

Regulatory aspectsGMP inspections from ANMAT

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

Argentina

New Regulatory Challenges and

Perspectives

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

Official and unofficial import restrictions 2010 -

2012

Drug products: ‘Automatic Authorization’…

February 2012 Anticipated Sworn Statement for Importation form to be submitted electronically before placing purchase order

Three signatures before validation:

• Federal Administration of Public Income (AFIP) – 72 h• Secretary of Domestic Trade• ANMAT

ISSUES

- Implementation – delays

- Commercial balance evaluation- Similar products manufactured locally

Less flexibility for the industry

Consumers associationsPharmacists associations

Shortage of products

up to 10 days

New Orphan Drug Regulation

Previously: only special process for importation of drugs for compassionate use

Very recently! August 2012 regulation for registration of drugs

‘under special conditions’ Definitions

Requisites

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’

ANMAT ‘Public Opinion’ space

Proposed text

Feedback form

Open for the general public to

participate

Projects for new regulations

Food, Household Products, Cosmetics, Medical Devices, Drugs, Dietary Supplements, Others

www.opinion_publica.anmat.gov.ar

in Argentina

Assesing the use of

eSubmissions

eSubmissions: step by step

2010: ‘depaperization’ projectGoals: better service – efficient administration – lower costs – greater transparency

First steps:• Electronic payment• Digital signature

Currently:• Clinical studies submissions• Importation authorization requests for

dietary supplements and medical devices

• Submissions for registration of cosmetics

Gracias!

Thank you!

• Verónica Casaro

And the rest of my Bayer Argentina colleagues:

• Valeria Wilberger• José Luis Role• María Inés Pérez• María Cecilia Díaz

• Rafaela Zunini• Fernanda Balbi• Silvia Fabrizio• Panchi Domínguez• Verónica Macías

• My Bayer GRA Berlin colleagues

• Austin Keeble (my favorite proofreader)

http://niniguaia.wordpress.com/

drug registration in argentina

Business