The document summarizes key information about Argentina's economy, healthcare system, and pharmaceutical industry and regulations.
1) Argentina has a $435.6 billion GDP, ranks 27th in the world and 3rd in Latin America. It has an annual growth rate of 8.8%, ranking 12th globally and 1st in Latin America. Services make up 60% of GDP, industry 30%, and agriculture 10%.
2) Healthcare spending is 8.5% of GDP, with 48% covered by social security and 9% by voluntary insurance. The top therapeutic areas are nervous system, cardiovascular, and digestive disorders. 38% have no healthcare coverage.
3) Drug regulation is overseen by the National Administration
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA 201T)
Semester II - Regulatory Aspects of Drugs and Cosmetics (MRA 201T)
Unit V - Regulatory pre-requisites related to Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia
(REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREMENTS IN SAUDI ARABIA)
Drug approval process in Saudi Arabia - Saudi Food & Drug Authority
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Regulatory requirements for drug approval in Saudi ArabiaSridhar S
Any drug after manufacture it should undergo the approval process under the the regulatory authority of the country to market the drug.
in this slides i have explained the requirements for approval and approval and approval procedure of the drug product in Saudi Arabia
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA 201T)
Semester II - Regulatory Aspects of Drugs and Cosmetics (MRA 201T)
Unit V - Regulatory pre-requisites related to Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia
(REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREMENTS IN SAUDI ARABIA)
Drug approval process in Saudi Arabia - Saudi Food & Drug Authority
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.
Latin America: Challenges & Opportunities in Clinical ResearchMedpace
With an established regulatory environment and a strong healthcare infrastructure, Latin America continues to grow as an advantageous landscape for conducting clinical research. Join Medpace experts Anibal Calmaggi, MD, Senior Medical Director, Infectious Diseases and Vaccines, and Wanda Dobrzanski, MD, Director Clinical Operations, Pediatric infectious diseases and Pharmaceutical medicine specialist, as they share their collective 36 years of experience in designing and managing clinical research in Latin America.
This presentation discusses:
• Advantages and benefits of running trials in Latin America
• Challenges and strategies for addressing them
• Required procedures and processes
• An in-depth look at the most significant Latin American countries for conducting clinical research
Clinical research in Latin America: constraints and opportunitiesCER Clinical Trials
The number of patients enrolled in international multi-centre clinical trials has increased in some countries of Latin America. Eduardo Gotuzzo, M.D. FACP
Brazil International Ltd. is a boutique company that provides business
services for companies in the medical device field, seeking to
successfully penetrate and participate in the Brazilian market.
An introductory overview of drug regulation in the biotch industry. Provides and intro to cGMP, FDA Inspections and Logistics and Drug Regulation History in the U.S.
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What is a biocidal product? How can I determine if a product is a biocide or cosmetics product? What are legal obligations when it comes to biocides? What is the difference between authorization and notification of biocidal product during the transitional period?
All these questions and more are answered in this presentation. If you have more questions regarding biocides, please feel free to contact me and I will be happy to answer.
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
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Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
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The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
VAT Registration Outlined In UAE: Benefits and Requirementsuae taxgpt
Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
https://viralsocialtrends.com/vat-registration-outlined-in-uae/
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
2. Argentina – an emerging economy
$435.6 billion GDP Services 60%
#27 World
#3 Latin America
Industry 30%
8.8% annual growth rate Agriculture 10%
#12 World
#1 Latin America
40 million people
13 million in Buenos Aires and surroundings
30% below poverty line
3. HealthCare and Pharma in Argentina
Pharma industry revenue: about
8.5% of GDP in HealthCare
$4,000 million / year
Voluntary +
Voluntary Social More than half of the market is taken by local
insurance security pharmaceutical companies
9% 4%
HealthCare Nervous System 15.9
system Cardiovascular system 14.2
Digestive system 13.8
No
coverage Systemic antiinfectious 11.2
38%
Antineoplasic and
Social 11.0
inmunomodulators
Security
48%
Muscle-skeleton
aparatus
7.7 %
4. National Regulatory Authority of
Regional Reference (PAHO/WHO)
The drug agency in Argentina
National Administration of
Drugs, Food and Medical Technology
National Institute Direction of Drug Direction of Planning and
Institutional Relations
of Medicines Product Evaluation
(INAME)
Control of Clinical evaluation Direction for Coordination
sites, processes, activities, technologie and Administration
s:
manufacturing, importation, fractioning
, marketing
Direction of National Institute of
Direction of Legal Affairs
Medical Technology Food
5.
6. Drug registration in Argentina
Decree 150/1992 and modifications
Lists of countries by sanitary trust level
ANNEX I USA France ANNEX II Australia China
High Sanitary Japan United Mexico Luxembourg
Surveillance
Kingdom
Brazil Norway
Sweden Netherlands
Cuba New Zealand
Switzerland Belgium
Chile
Israel Denmark
Finland
Canada Spain
Hungary
Austria Italy
Ireland
Germany
7. Drug registration in Argentina
• Product information - name, formula,
‘Article 3’ products pharmaceutical form, pharmacologic
classification, marketing condition
DPs manufactured in Argentina or • Technical information - testing
an Annex II country, similar to DPs standard, specifications, shelf life,
already registered in Argentina. manufacturing method, pharmaceutical
equivalence evidence
DPs manufactured in Argentina,
with marketing authorization in an • Labeling texts (packaging and leaflets)
Annex I country, even if ‘novel’*.
• If manufactured in an Annex II country: CPP
Timeline for of origin
approval: about
12 months * ‘Novel’ products: there are no similar
products registered in Argentina • GMP from Annex I country or Argentina
8. Drug registration in Argentina
‘Article 4’ products
• CPP from Annex I country –
DPs with marketing authorization Marketed status
in at least one Annex I country.
• Labeling texts (packaging and
leaflets)
Timeline for
approval: • Technical information - only
about 10 upon authority request
months
9. Drug registration in Argentina
= ‘Article 3’ DPs
• Product information
‘Article 5’ products
• Technical information
‘Novel’* DPs manufactured in Argentina.
• Labeling texts
‘Novel’* DPs manufactured in an Annex II
country. • If manufactured in an Annex II country:
CPP of origin
DPs manufactured in a non-Annex I, non-
Annex II country, and not authorized in • GMP from Annex I country or Argentina
any Annex I country.
plus
Timeline for approval: not
less than 3 years
Safety and efficacy data
10. Renewal of certificate
Every 5 years Documents
(within 30 days prior to • Written request
certificate expiration date)
• Sworn statement – marketed/non
marketed status
• Evidence of marketing
Relatively simple procedure • Certified copy of original certificate
• Copy of last approved labeling texts
11. •
•
Local manufacturing
Importation of drugs Local QC
‘First Batch Verification’
• New product registration Submit form , manufacturing/QC schedule,
• New concentration of technical information, pay fee
biologic or small-
therapeutic-window APIs ANMAT inspects ANMAT doesn’t inspect
• New pharmaceutical
form Send
• Marketing authorization manufacturing/QC
transfer documents
Positive outcome
Marketing Authorization
12. Variations of regulatory impact
Examples:
• Change of excipients
• Change of manufacturer or Submit documents
manufacturer’s name (only for DP) (very variable requirements)
• Change in labeling texts – leaflets
and packaging – including new
indications Wait for approval
• Shelf life extension
• Change of marketing condition
• Marketing authorization transfer
• New primary packaging material
13.
14. GMP inspections from ANMAT
Application for inspection :
When?
documents
For DP manufacturing sites when • Written request
not in Annex I country, and without • Copy of ANMAT authorization to requestor
certificate from Annex I country. • Information on manufacturer/s
• Site Master File
• DP specific • Site authorization from HA in country in which
it is.
• Agreement with MERCOSUR countries • List of pharmaceutical forms manufactured in
(e.g. ANVISA) 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
15.
16. New OTC labeling regulations
Study: Patients hadof PILs interpreting
the content
trouble
Information in question
format
February 2012 What is…? What is … used for? What
warnings are required before/during
new definitions and the use of…? How should I use…?
What should I do if…?
guidelines for labeling texts in leaflets and
packaging of all OTC drug products Illustrations may be
added for better understanding
• 2 years for submitting updated texts
Only information relevant to
• Immediate application for new registrations,
variations and change of marketing condition the patient in layman’s terms
17. Official and unofficial import restrictions 2010 - 2012
Drug products: ‘Automatic Authorization’… ISSUES
- Implementation – delays
Anticipated Sworn
February 2012 - Commercial balance evaluation
- Similar products manufactured
Statement for Importation locally
form to be submitted electronically before placing purchase order
Less flexibility for the
industry
Three signatures before validation:
Consumers associations
• Federal Administration of Public Income (AFIP) – 72 h Pharmacists associations
• Secretary of Domestic Trade
• ANMAT up to 10 days Shortage of products
18. Orphan Drugs
• Low frequency
disorders (<1/2000)
• Severe diseases (risk
of incapacity or death)
New Orphan Drug Regulation
• Complete information of (at least) early
Previously: only special process for phases of clinical research (preclinical
importation of drugs for compassionate use and phases I and/or II) – adapted trials
Very recently! August 2012 regulation • Evidence of orphan status
‘under
for registration of drugs • Plan of efficacy, efficiency and safety
monitoring (patient register,
special conditions’ •
prescription/distribution scheme)
Periodic reports
Definitions
• Intensive pharmacovigilance
Requisites • Informed consent
Creation of special committee of • Labeling: ‘AUTHORIZED UNDER
evaluation
SPECIAL CONDITIONS’
19. ANMAT ‘Public Opinion’ space
Projects for new regulations
Proposed text
Food, Household Products, Cosmetics, Medical
Devices, Drugs, Dietary Supplements, Others
Feedback form
Open for the general public to
participate
www.opinion_publica.anmat.gov.ar
20.
21. eSubmissions: step by step
2010: ‘depaperization’ project
Goals: better service – efficient administration – lower costs – greater
transparency
Currently:
First steps: • Clinical studies submissions
• Electronic payment • Importation authorization requests for
• Digital signature dietary supplements and medical
devices
• Submissions for registration of
cosmetics
22. • Verónica Casaro • My Bayer GRA
Berlin colleagues
And the rest of my Bayer Argentina colleagues:
• Austin Keeble
• Valeria Wilberger • Rafaela Zunini (my favorite
• José Luis Role • Fernanda Balbi proofreader)
• María Inés Pérez • Silvia Fabrizio
• María Cecilia Díaz • Panchi Domínguez
• Verónica Macías
http://niniguaia.wordpress.com/
Editor's Notes
Como se organiza ANMAT, dondequeda, organigrama, de quiendepende, cuando se formo, como se maneja
Como se organiza ANMAT, dondequeda, organigrama, de quiendepende, cuando se formo, como se maneja
Como se organiza ANMAT, dondequeda, organigrama, de quiendepende, cuando se formo, como se maneja