The 1st Brazil-Japan Seminar on pharmaceuticals and medical devices regulations. Efficiency of product review on medical devices and pharmaceuticals

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Efficiency of product review on

medical devices and pharmaceuticals

The 1st Brazil-Japan Seminar on

pharmaceuticals and medical devices regulations

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OBJECTIVES

To offer an overview related to Sindusfarma

activities, evolution of the Brazilian medicines

market, regulation, harmonization and

convergences applied to the pharmaceutical

industry.

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CONTENT

1.Sindusfarma – attributions and main activities

2.The evolution and milestones of regulation for pharmaceutical industry.

3.Convergences efforts related to efficacy, safety and quality of medicines

4.Sindusfarma educational and institutional programs 5.Conclusions

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Legal attributions

The attributions of Sindusfarma, like those of any other

Brazilian trade unions, are provided in the Labor Code, and basically include:

- the conduction of studies, legal protection and coordination of the category;

- collaboration with governmental authorities and other associations towards social solidarity and serving the country’s national interests.

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Main attributions

To assist entities, memberships and professionals in all

regulatory and technical subjects;

To promote events, plenary meetings, and informative bulletins

to updating proposes.

To develop and offer a continuous education annual programs; To provide technical information by publishing manuals and

books;

To conduct collective bargaining, agreements, interchange,

and cooperation programs with national and international organizations.

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Services I

The services provided to members in different fields of expertise include:

• newsletters reproducing the legislation and regulations applicable to the pharmaceutical industry;

• coordination of working groups to study specific themes of interest for the category with a view to organizing the entity’s position or structuring educational programs;

• scheduling informative meetings with members to spread and comments on regulations newly incorporated to the applicable legislation;

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Services II

customized services for members;

 _{issuing letters on an exclusive basis to enable members to}

take part in public bids;

 managing the BES (Sindusfarma Employment Jobs Bank),

for both new applicants and pharmaceutical industry demand, connected with the PAP (program to support professionals);

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10.695.532 6.249.682 10.439.601 3.480.937 732.793 451.227 668.68 9 6.569.683 7.588.078 14.021.432 19.595.309 3.033.991 1.560.501 2.449.341 8.448.055 3.168.1 33 3.766.834 8.796.032 3.120.92 2 2.068.031 3.512.672 15.993.583 41.252.1 60 3.119.015 6.004.045 1.383.453 2.562.963 Population 2000 169.799.170 Population 2010 190.732.694 BRAZIL – POPULATION Sindusfarma Sinfar Sindifar Sinqfesc Sinfacope Sindusfarq Sinquifar-JF Quifarmo Sindifargo Sindquímica Sinquifar-NP Sinqfar Sinquifarma

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1250 Brazilian Industry Syndicates Congregates: 350.000 companies

Industry Federation FIESP – São Paulo State

26 Federations - Brazil

CNI

Brazilian Industry Confederation

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183 36% 38 7% 73 14% 54 11% 23 5% 136 27% São Paulo Goiás Rio de Janeiro Minas Gerais Paraná Demais Estados

Fonte: Ministério do Trabalho e Emprego - RAIS Elaboração: Sindusfarma / Gerência de Economia

Total = 507 companies

'

Human Medicines production units Number of establishments/States

Position: 31/12/2012

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43.679 55% 9.323 12% 6.895 9% 6.015 8% 4.203 5% 8.907 11% São Paulo Goiás Rio de Janeiro Minas Gerais Paraná Demais Estados BRAZIL = 79.022 employers

Fonte: Ministério do Trabalho e Emprego - RAIS Elaboração: Sindusfarma / Gerência de Economia

Human Resources – Human Medicines Production Number employers/States

Position: 31/12/2012

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12 Governmental Manufacturer Laboratories and Importers Independent Pharmacies Manufacturer And Importers Governments Logistics operator Wholesalers and distributors Pharmacy chains Health Centers and Publics Ambulatory Hospitals and Clinics Stores Pharmacy chains

Brazil - Human Medicines value chain data flow

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Brazilian Market – Pharmacy channel

-300,000,000 200,000,000 700,000,000 1,200,000,000 1,700,000,000 2,200,000,000 2,700,000,000 3,200,000,000 3,700,000,000 0 5,000,000,000 10,000,000,000 15,000,000,000 20,000,000,000 25,000,000,000 30,000,000,000 35,000,000,000 40,000,000,000 45,000,000,000 50,000,000,000 55,000,000,000 60,000,000,000 65,000,000,000 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 **2014 V en d as em U n id ad es V en d as em R $ e U S $

MERCADO FARMACÊUTICO - BRASIL (Canal Farmácia)

Vendas em Reais (R$), em Dólares (US$) e em Unidades (caixas) Período: 2003 a 2014(**)

Vendas em R$ (*) Vendas em US$ (*) Vendas em Unidades

Fonte: IMS Health

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6.39% 7.60% 8.98% 10.73% 12.48% 13.87% 15.00% 17.20% 20.50% 22.49% 23.64% 7.79% 9.35% 11.43% 13.57% 15.36% 16.99% 18.67% 21.22% 24.90% 26.29% 27.26% 0% 5% 10% 15% 20% 25% 30% 35% 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 P ar ti c ip aç ã o % n a s V en d a s T o ta is d o M e rc a d o

Participação dos Genéricos nas Vendas Totais do Mercado, em Reais (R$)

Participação dos Genéricos nas Vendas Totais do Mercado, em Unidades (Caixas)

Fonte: IMS Health

Elaboração: Sindusfarma / Gerência de Economia

Brazilian Generics Human medicines - (Pharmacy Channel) Proportion with total market

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Market Pharmaceutical World Ranking US$ Período: 2012 (1) e 2016 (2) 2012 (1) 1º 2º 3º 4º 5º 6º 7º 8º 9º 11º 10º 12º 13º 14º 2016 (2) 1º 2º 3º 4º 5º 6º 7º 8º 9º 11º 10º 12º 13º 14º

(1) 12 meses móveis até Dezembro de 2012

(2) Estimativa

Source: IMS Market Prognosis, Apr 2012

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PHARMACEUTICAL PRODUCTS - CHAPTER 30 OF NCM Evolution of Brazilian Exports/Imports - Period: 1997-2014

0 1,000,000,000 2,000,000,000 3,000,000,000 4,000,000,000 5,000,000,000 6,000,000,000 7,000,000,000 8,000,000,000 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 20132014* Em U S$ F O B

Exportações (US$ FOB) Importações (US$ FOB)

Fonte: MDIC/Secex¥Sistema Alice

Elaboração: Sindusfarma / Gerência de Economia * Acumulado até Junho de 2014

PRODUTOS FARMACÊUTICOS - BALANÇA COMERCIAL

EXPORTAÇÕES E IMPORTAÇÕES BRASILEIRAS - CAPÍTULO 30 DA NCM PERÍODO: 1997 a 2014* - EM US$ FOB

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Requirements for drug market authorization

 _{Innovators – RDC 136/2003}  _{Generics – RDC 16/2007}

 Similar –RDC 17/2007

 Specifics – RDC 132/2003 (OTC included)  Biologics – RDC 315/2005

 Phitotherapics – RDC 14/2010  _{Homeophatics – RDC 26/2007}

Brazilian Pharmaceutical Industry Legislation

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 1995: GMP Inspection – Resolution SVS Nº 16/1995, according WHO 1975.

 2001: GMP Inspection – Resolution Anvisa nº 134/2001, according WHO 1992 and Mercosur.  _{2003: GMP Inspection – Resolution Anvisa nº}

210/2003, according WHO 1992 – with local proposals  2010: GMP Inspection – Resolution Anvisa nº 17/2010

according WHO 2006 – with local proposals

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Convergences efforts Brazil – Japan related to

efficacy, safety and quality of medicines.

To learn how could be points of convergences in order to

reduce asymmetries in:

Good Manufacturing Practices

Good Distribution Practices

To know the PMDA initiatives related to track and trace

of medicines;

_{To learn how could be implemented the PIC/S to}

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Convergences efforts Brazil – Japan related to

efficacy, safety and quality of medicines.

To learn how could be points of convergences in order to

reduce asymmetries in:

_{To know the different categories of medicines and how}

could be criteria to establish convergences related to have drug market authorization;

 To learn how PMDA are conducting knowledge related

to safety and efficacy of essentials and non essentials amino acids used in food supplements;

 To study the convergences and eventual asymmetries

phamacovigilance system;

 To learn how could be a process for the cooperation

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Convergences efforts Brazil – Japan related to

efficacy, safety and quality of medicines.

To learn how could be a cooperation between PMDA –

ANVISA in order to contribute for a program to include ANVISA in the ICH concern, considering to attend contingency demand of Japan;

To establish a continuous cooperation process between PMDA

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Sindusfarma is a pioneering entity in the publication of manuals and books for the Pharmaceutical Industry oriented to occupational

safety issues. Collection with 14 volumes.

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Sindusfarma is a pioneering entity in the publication of manuals and books for the Pharmaceutical Industry, particularly on

technical-regulatory issues. Collection with 20 volumes.

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TRIBUTARY COLLECTION

Arrecadação Fiscal no Brasil: 2005 à 2011

Redução do ICMS sobreMedicamentos

Ampliando a Inserção Internacional dos Setores Farmoquímico e Farmacêutico Brasileiros:

Alternativas Estratégicas

Iniciação à Classificação Fiscal de Produtos da Indústria Farmacêutica e Correlatas

na Nomenclatura Comum do Mercosul

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Sindusfarma Institutional Books

Sindusfarma 80 anos

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2009 2009 2010 2011 The “Cândido Fontoura do Mérito Industrial Farmacêutico Collar ” is intended to honor those personalities who stand out for rendering significant services to the industrial pharmaceutical sector and to associative entities of the Pharmaceutical Industry in Brazil.

2012

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2010 2011

2012

The Sindusfarma Quality Award is a recognition for the previous year’s outstanding pharmaceutical companies and suppliers, in different categories, to reach the quality standards required by the sector.

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The Boomerang Awards for best practices in training and development, recruiting and selection is a recognition of the efforts of our members in these activities.

GST – Work Health and Safety Management, commitment to compliance with the Regulatory Standards issued by the Labor Ministry, which reflects in the reduction of occupational accidents.

Ceremony – MAM (Modern Art Museum) – August 15th, 2012.

Boomerang award GST award

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Promotes integration among the professionals of member companies, encourage and stimulate and reward sports teams and individual winners.

It is an annual event with games and exhibits, under the slogan "Healthy Living is our movement."

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Brazil – Life Expectation

0 10 20 30 40 50 60 70 80 90 100 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 2020 2030 2040 2050 2060 2070 2080 2090 2100 3 4. 6 3 5. 2 3 7. 3 4 2. 7 4 3. 3 4 8 52. 7 62. 7 6 6. 6 7 0. 4 7 3. 4 8 7 6. 1 7 8. 2 8 0 ₈1. 3 8 2. 3 8 3. 1 8 3. 6 8 4. 1 8 4. 3 E sp e ra n ç a d e v id a a o n a sc e r

Fonte: IBGE, Censos Demográficos 1910-2000 e Projeção da População do Brasil para o Período 1980-2050.

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Conclusions

The “1st Brazil-Japan Seminar on pharmaceuticals and medical devices regulations Time Line” is a real

opportunity to joint both ANVISA & PMDA to learn with each other to reach more benefits for Brazilian and Japanese population;

To start a process of cooperation with identification

of regulatory asymmetries and convergences;

To establish a project to increase commercial trade

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Obrigado!/Thank you!

www.sindusfarma.org.br

Lauro D. Moretto

Executive Vice President