Key Points (1)

Definitions:

• Bureaucracy.• Regulatory Affairs.

Quality:

• Historic.• Quality Wave.• Benefits.

Key Points (2)

Regulatory Affairs:

• Historic.• American and European

Systems.• LATAM: Products and Services.• The regulatory affairs system as

a non-tariff barrier.• The Regulatory Affairs’

maintenance cost.• When the RA meets the

Bureaucrassaur!

• The Regulatory Affairs Professional: this distinguished unknown...

• When the RA meets the Bureaucrassaur!

• The Regulatory Affairs Professional: this distinguished unknown...

• Conclusions.

• Questions & Aswers.

Definitions

Do you know the difference between Bureaucracy and Regulatory Affairs?

Definitions

• Bureaucracy:

1. Administration of the public thing by public employee subject to hierarchy, rigid rules and inflexible routine;

2. Complication or slowing in the development of the public services.

• Regulatory Affairs:

Group of laws, norms and technical regulations that determine the participation of buyers and vendors in a certain field of the regulated economic activity.

Let’s talk a little bit about Quality?

Historic of Quality

Evolution

World

Chronology

1900Inspection

made by the employee / supervisor

1920Quality

Control as a

specialized function

1940Statistical Control of

the process

1960Total

Quality

1980Systems

of Quality

Assurance

2000Quality

Systems Management

Still talking about Quality

Features:• Defined systems.• Measurable.• Standardization. • Performance Indicators.

Benefits:• Costs reduction.• Control of the measurable

parameters.• Process monitoring.• Domain of the process

(reliability).• Routine optimization.• Objective improvement of

the goods.

Regulatory Affairs

Did you receive the unexpected visit of the Inspector???

Regulatory Affairs

Hiding is not an option...

Regulatory Affairs

Insulting the inspector will just make things worse...

Regulatory Affairs

How about solving the problems and try to understand the Regulatory Affairs’ rules???

After all your business continues to be extremely attractive!!!

Historic

• XVIII and XIX centuries – Harbor Police (Brazil)• I and II World War – re-directed to therapeutic.• 1976 – Health Products Legislation Started• 1999 – Establishment of the First Federal Agency

Fully Dedicated to Regulatory Affairs (Brazil)

Mission / Values / Vision Of The Latam Regulatory Affairs System

From ANVISA (that is followed by other countries)

• Mission"To protect and promote health, ensuring the hygiene and safety of products and services and taking part in developing access to it."

• ValuesTransparencyKnowledge (as a springboard for action)Cooperation.

• VisionTo be an agent for transformation of the decentralized regulatory system, within a network, holding a distinct position, legitimized by the population, as regulator and promoter of social well-being.

CONTROL

Basic Actuation:

• Manufacturers and Importers of:• Pharmaceuticals;• Cosmetics;• Sanitizers; • Food;• Medical Products (equipments, consumables and

disposables).

• Health services (hospitals and clinics).• Harbors, airports and frontiers.

Summarizing:

LATAM Regulatory Affairs Authorities determines the rules of the game from the manufacturing, importing and distributing point of view as well as health services.

The system is mostly reactive (but not exclusively) answering to past events.

Are you following???

Summarizing the Scenario…• Products and services controlled

by LATAM Regulatory Affairs authorities have rules clearly determined.

• To survive and gain some competitive advantage you must understand the LATAM Regulatory Affairs System.

• Do not try to play games because LATAM Regulatory Affairs authorities are monitoring the market (hey, I am talking to you!!!)

TRY TO GUESS WHO’S YOUR COMPANY…

European and American System

Europe:• System created after the

2nd World War to integrate all States: planning (pro-active system).

• Products approved can be freely sold in all EU territory.

• Each Nation is free and independent to adopt the directives at its own time and convenience.

United States of America:• Reactive system created

to inspect all companies and products.

• Separations of the state and federal authorities..

• Pressure.• Federal product

registration is required.

European and American SystemCommon points of the two systems:

• Facilities:• Quality standards based on the activities developed.

• Products:• Classified according to the risk.• Regulated by class of products.• Product use as indicated by the manufacturer but the user can change it

under his/her own responsibility.• Techno and Pharmaco Vigilance.• Control of the Clinical Evaluation Protocols under the express

agreement of the volunteers.

Latin America Countries

• Operation: like FDA:• Central power.• Decentralized action.• Requires: • Registration of the manufacturers and importers.• Registration of Products.

• Documents required: like EU’s Master File.

Company’s Working Permit Approval

Company Establishment:- Social Contract;- Tax ID Card

- Facilities;- Legal and Technical

Responsible.

Preparation and Submission of the 1:100 Print + Lay Out for local

Approval.

(60 - 90 days)

Preparation and Submission for the Local

Working Permit.

(120 days)

Preparation and Submission for the

Federal Working Permit

(90 days)

Extra Zone Inspection

Product Registration

Collection of the Needed Documents

Critical Analysis of the Documentation

Assembling of the Technical Dossier According to the

LATAM Requirements

Fees Payment and Collection of the

Needed Signatures

Submission of the Technical Dossier

Technical Analysis by LATAM Staff

Product Approval (Publication in the

Federal Official Gazette)

Request for Additional Information

Preparation and Submission of the

Requested Information

Basic List of Needed Documents for Products Registration

• COMPANY’S WORKING PERMIT• FREE SALES CERTIFICATE* (WHEN APLICABLE)• LETTER OF DISTRIBUTION* (WHEN APLICABLE)• CERTIFICATE OF CONFORMITY• GMP CERTIFICATE• INSTRUCTIONS OF USE / INSERTS• SERVICE / INSTALATION MANUAL• LABELING• PACKING• COMPOSITION / QUALI-QUANTI FORMULA• BASIC MANUFACTURING FLOWCHART• CERTIFICATION OR LOCAL TESTS MAY BE REQUIRED DEPENDING ON THE PRODUCT• VALIDATION OF STERILIZATION PROTOCOL (WHEN APPLICABLE)• PROOFS OF SAFETY AND EFFECTIVENESS(*) Consularization required in the closest embassy/consulate of the countrie where the product will be registered.

Attention now!

Let’s talk about the Non Tariff Barriers.

In front of the Regulatory Affairs scenario you can behave like this...

Or like that!

Non Tariff BarriersIn the whole World NOW!

• Commercial agreements being signed among countries of a same group (Mercosur, Alca, CEE, Nafta, etc.).

• Commercial agreements being signed among countries of different groups (Brazil and China, Brazil and México, etc.).

• The agreements define the commercial conditions: Tariffs and Quotes of Purchasing.

What kind of protection is left then?

** Regulatory Barriers **:

• The countries have autonomy to define the rules of the game regarding quality, products specification, ways to register a product, documents and tests required, etc.

Non Tariff Barriers

Trying to Manufacture, Export or Import without being in conformity with the Regulatory system???

Regulatory System X Bureaucrassaur.

Regulatory System X Bureaucrassaur

In Brazil:• 152 days: time to

legally establish a company in Brazil.• Number of Needed

Procedures: 17• Up to10 years: time

to close a company in Brazil.

• Local Working Permit:120 days up to 1 year.

• Federal Working Permit: 30 up to 120 days.

• GMP Certificate by ANVISA: 1,5 up to 2,5 year.

• MD or IVD Registration: 2 up to 5 month.

• Approval of Clinical Evaluation Protocol: 6 month.

• High Cost for Regulatory Affairs Systems Maintenance.

Regulatory System X Bureaucrassaur

Wait! You may not like what I am going to say but it is extremely important!

Do not follow your instinct to solve everything in “petit comitê”. Think BIG!

Regulatory Affairs System Advantages(Hawk X Turtle)

Who Are You? HOW DOES YOUR COMPANY BEHAVE?

Some Advantages of Being in Conformity with Local Regulatory Affairs

• To be in conformity with the Local Legislation.

• As an answer to a market more and more conscious.

• Respect to the Consumer.

• Opening of new business opportunities.

• Advantage over non-conform competitors.

• Support to Import and Export process.

• Improves the Company’s image in the local market.

You did not like? Then, let’s see...

If you do not follow the local Regulatory Affairs Legislation.

• Arrest from 10 up to 15 years in jail.

• Company’s interdiction.

• No participation in public bids.

• No importation & exportation.• Loss of company’s value

(specially those in the stock market).

The regulatory issue has to be faced. There is no solution in trying the easy escape...

The Regulatory Affairs Professional.

RA Professional Profile (I) • Need of various technical background

(please do not sacrifice the assistant!).

• Experience in other carriers directed to technical areas.

• Experience in vital to the RA Professional.

• Management capabilities (technical and finance) and highly

organized.

• Continuous education. The company MUST invest in the RA

Professional.

RA Professional Profile(II)• Ability to make market analysis, understand the legislation and

new technologies and foreseen the future consequences that can affect the company’s business as well as present possible solutions.

• Support to the company’s team and for each member individually.

• Active participation in local associations, task forces and collaboration with Governmental Regulatory Affairs authorities.

RA Professional Profile - (Summary)

• Communication.

• Sympathy.

• Sociability.

• High interest in acquiring new information daily.

• Interest in continuous education.

• Knowledge of management, finance, project management and foreign languages.

• Deep technical knowledge of the products made / imported / sold by his (her) company.

If your company decides not to invest in Regulatory Affairs this will be the result...

But if they invest...

Conclusions (I)The CEO and ALL team has to monitor, scan and understand the scenario 100% of the time. It is a WAR operation! Keep you radar on all the time.

Conclusions (II)Risk Management must be the first thought in the mind of all team, specially for the Regulatory Affairs guys.

To read and follow the legislation and technical norms daily is VITAL.

And Finally about LATAM• It is a very interesting, growing and profitable market;• Companies interested in selling in Latin America have to

deeply know the local legislation;

•Anticipation is the “Magic” word when we think Latin America.

Thank You for your Attention and Patience!

Av. Vereador José Diniz, 2270

São Paulo / SP / Brazil

Tel.: (011) 5090-5080.

Fax.: (011) 5090-5083.

E-mail: latini@latini.com.br

Website: www.latini.com.br

Offices: São Paulo / Brasília / Rib.Preto / Rio de Janeiro

Intel Partnerships: UK (Meddiquest) and 24 other countries.

Latini & Associados

Thank you!!!• Thanks for each one of the Delegates (and their companies)

for coming and participating in this learning session. More than a Seminar this was a precious trade of information;

• Thanks for Mrs.Andrea, CEO of Management Forum and all team for inviting us to come to this wonderful country and this marvelous historical land called Europe;

• Thank you all!!

You are the Champions !!!