Efficiency of product review on medical devices and pharmaceuticals

The 1st Brazil-Japan Seminar on pharmaceuticals and medical devices

regulations

OBJECTIVES

To offer an overview related to Sindusfarma activities, evolution of the Brazilian medicines market, regulation, harmonization and convergences applied to the pharmaceutical industry.

CONTENT

1.Sindusfarma – attributions and main activities2.The evolution and milestones of regulation forpharmaceutical industry.3.Convergences efforts related to efficacy, safety and qualityof medicines4.Sindusfarma educational and institutional programs5.Conclusions

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.

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.

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;

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);

others

10.695.532

6.249.682

10.439.601

3.480.937

732.793

451.227668.689

6.569.683

7.588.078

14.021.432

19.595.309

3.033.991

1.560.501

2.449.341

8.448.0553.168.1333.766.8348.796.0323.120.922

2.068.031

3.512.672

15.993.58341.252.160

3.119.015

6.004.045

1.383.453

2.562.963

Population2000

169.799.170

Population 2010

190.732.694

BRAZIL – POPULATION

SindusfarmaSinfar

SindifarSinqfesc

Sinfacope

SindusfarqSinquifar-JF

Quifarmo

Sindifargo

Sindquímica

Sinquifar-NPSinqfar

Sinquifarma

1250 Brazilian Industry SyndicatesCongregates: 350.000 companies

Industry FederationFIESP – São Paulo State26 Federations - Brazil

CNI

BrazilianIndustry

Confederation

Structure Brazilian Industry Representation

18336%

387%73

14%

5411%

235%

13627%

São Paulo

Goiás

Rio de Janeiro

Minas Gerais

Paraná

Demais Estados

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

Total = 507 companies

'

Human Medicines production units Number of establishments/States Position: 31/12/2012

17

43.67955%

9.32312%

6.8959%

6.0158%

4.2035%

8.90711%

São PauloGoiásRio de JaneiroMinas GeraisParanáDemais Estados

BRAZIL = 79.022 employers

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

Human Resources – Human Medicines Production Number employers/States Position: 31/12/2012

16

12

GovernmentalManufacturerLaboratories

andImporters Independent

Pharmacies

ManufacturerAnd

Importers

Governments

Logistics operator

Wholesalers and distributors

Pharmacy chains

Health Centersand PublicsAmbulatory

Hospitals andClinics

StoresPharmacy chains

Brazil - Human Medicines value chain data flow

Publics Hospitals

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

Vend

as e

m U

nida

des

Vend

as e

m R

$ e

US$

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 HealthElaboração: Sindusfarma / Gerência de Economia (**) 12 meses móveis até Junho/2014

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

Part

icip

ação

% n

as V

enda

s To

tais

do

Mer

cado

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

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

Fonte: IMS HealthElaboração: Sindusfarma / Gerência de Economia

Brazilian Generics Human medicines - (Pharmacy Channel)Proportion with total market Períod: 2003 a 2013

MarketPharmaceutical World

Ranking US$Período: 2012 (1) e 2016 (2)

2012 (1)

1º2º

3º

4º5º

6º

7º

8º

9º

11º

10º

12º

13º14º

2016 (2)

1º

2º3º

4º

5º6º

7º

8º9º

11º10º

12º13º

14º

(1) 12 meses móveis até Dezembro de 2012(2) Estimativa

Source: IMS Market Prognosis, Apr 2012Elaboração: Sindusfarma/ Gerência de Economia

PHARMACEUTICAL PRODUCTS - CHAPTER 30 OF NCMEvolution 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

OB

Exportações (US$ FOB)

Importações (US$ FOB)

Fonte: MDIC/Secex¥Sistema AliceElaboração: Sindusfarma / Gerência de Economia

* Acumulado até Junho de 2014

PRODUTOS FARMACÊUTICOS - BALANÇA COMERCIALEXPORTAÇÕES E IMPORTAÇÕES BRASILEIRAS - CAPÍTULO 30 DA NCM

PERÍODO: 1997 a 2014* - EM US$ FOB

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

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

Brazilian GMP evolution

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 PracticesGood Distribution PracticesTo know the PMDA initiatives related to track and trace of medicines;To learn how could be implemented the PIC/S to perform inspection extra-zone.

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 between Brazilian and Japanese Pharmacopeia.

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 – ANVISA to reduce regulatory asymmetries.

SINDUSFARMA EDUCATIONAL PROGRAM

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.

PES – Sindusfarma Educational Program

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.

PES – Sindusfarma Educational Program

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

PES – Sindusfarma Educational Program

Sindusfarma Institutional Books

Sindusfarma 80 anos

2013

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 2013

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.

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 awardGST awardPES award

Promotes integration among the professionals of member companies, encourage andstimulate and reward sports teams and individual winners.It is an annual event with games and exhibits, under the slogan "Healthy Living is ourmovement."

Brazil – Life Expectation

0

10

20

30

40

50

60

70

80

90

100

19101920193019401950196019701980199020002010202020302040205020602070208020902100

34.6

35.2

37.3 42

.743

.3 48 52.7 62

.7 66.6 70.4

73.4

876

.178

.280 81

.382

.383

.183

.684

.184

.3

Espe

ranç

a de

vid

a ao

nas

cer

Fonte: IBGE, Censos Demográficos 1910-2000 e Projeção da População do Brasil para o Período 1980-2050.Elaboração: Sindusfarma/ Gerência de Economia

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 and cooperation for R&D of medicines.

Obrigado!/Thank you!www.sindusfarma.org.br

Lauro D. MorettoExecutive Vice President

lauromoretto@sindusfarma.org.br