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ANVISA - Ministry of Health The Brazilian Health Surveillance Agency

ANVISA`s Regulation Process on Drugs and Medical Devices: Achievements and Perspectives

Dirceu Raposo de Mello Director Chairman Washington, DF, September 2010

ANVIS

Values: · Ethics and responsibility as a public agent ·Capacity of articulation and integration ·Excellence in management ·Science ­ based decision ·Transparency ·Accountability

ANVIS

Areas of action

Food

Cosmetics

Sanitizing Products

Tobacco

Toxicology (pesticides)

Health services

Drugs

Medical Devices Laboratories

Blood and blood products

Post-market surveillance

Marketing control

Ports, airports and frontiers

International

Market regulation

Transparency and social participation

· Social control by SUS · Public Consultation and Notification · Public Audiences

· Managerial Report (annual)

· ANVISA's Consulting Council

· Ombudsman

· Letter of Services to Citizens · Public Meeting in the National Congress ­ annual presentation of the ANVISA's Report of · Call Center Activities

· Sector Chambers

Recent Results

- Qualification of ANVISA by WHO in the area of vaccines Pre authorization for WHO to purchase Brazilian vaccines to countries in situation of emergency and calamity. - Certification by PAHO as Regulatory Authority of Reference in the area of medicines PAHO issued ANVISA with the high level qualification. This evaluation will impact the process of drugs pre-qualification of PAHO, as well as will help guiding regional cooperation in the field of health surveillance. - ANVISA has also presented its Official Application to PIC/S. This will strength the relation among ANVISA and the main regulatory agencies in the area of inspection. It also represents a recognition of ANVISA`s requirements and procedures.

Brazilian Pharmaceutical Marke

450 Drug industries 2.100 Drug wholesalers 65.000 Private pharmacies 2,5 billions of units of drugs / year

REGULATION OF DRUGS AN MEDICAL DEVICE

Inspections

Post ­ Market Surveillance

Registration

Drug Registratio

· In Brazil, drugs are submitted to registration. · The registration must be renewed every five years. · Categories of Drugs registered in Brazil

­ "New" drugs (innovating and others)

· Synthetic and semi-synthetic drugs · Biologicals · Herbal drugs

­ Generic Drugs ­ Similar Drugs

Drug Registration Transparency Practices

- Publishing Reports on the Drug Registration Office (GGMED) in the website From 2009 on, it is published information about dossiers presented to the Agency, post ­ registration, clinical trials and notifications. It is also reported data concerning the relationship between the Agency and the private sector. -Publishing information on the "Line for Analyses" on the website The requests and dossiers are organized in a chronological "Line" (from the older to the newest, considering date of entrance at ANVISA). The analyses of one request can be prioritized by the Agency considering the Public Health Policy, as the criteria established on RDC 28/2007

News in last 5 year

Improvement of working process of the Drug Registration Office ­ Security and Efficacy Intensive training and use of the own staff in the analysis of innovative drugs (new therapeutic indication, new pharmaceutical forms, new concentration, new associations). Result: The process of analysis down from 24 to 12 months.

Creation of the Coordination for Instruction and Analysis of Resources ­ COREC ­ to advice the Collegiate Board.

10

ANVIS Results in the drug secto

Drug Licences issued by ANVISA New Drugs Generic Drugs Similar Drugs Biological Drugs Herbal, Homeopathic and specifics 73 73 116 75

2006 2007 2008 2009

45 49 48 126

320 297 336 377

60 139 129 193

43 22 28 32

ANVIS Results in the drug secto

Drug Dossiers presented to ANVISA in 2009

Licenses Issued Biological Drugs Herbal, Homeopathic and specifics Generic Drugs New Drugs Similar Drugs 45 49 Licences Analyzed 320 297 Licenses Renewed 60 139 Post ­ Licence Analysis 43 22

48 126 193

336 377 1346

129 193 372

28 32 856

Drug licensin

Perpectives for 2010 / 201

· Eletronic License of Drugs · Auditing of Licensing and post- licensing · Reference Drugs · Radiopharmaceuticals · Already known biologic produtos and new biological products

SDatasSoEconomic information on the Sector of Medical Devices

Medical Devices

Requirements

Based on a risk approach

· Four classes of risk (I ­ low, II ­ medium, III - high, IV ­ maximum). The requirements increase according the level of risk. · Risk classification based on GHTF guideline SG1N15:2006

Medical Devices

Requirements

Types of pre-market approval: Registration and Notification

· Registration process (GMP inspection required):

· Devices classified on risk categories III and IV, and some special

products under categories I and II (devices used by laypersons in households. Equipment: glucometer), that follow a simplified registration process. · Based on Essential Principles of Safety and Performance of Medical Devices, established by RDC Anvisa nº 56/2001, according to GHTF guideline (SG1-N41R9:2005), adopting ISO and IEC standards; · Labeling requirements: most of them based on GHTF guideline SG1N43:2005.

Medical Devices

Requirements

Types of pre-market approval:

· Notification process (GMP inspection NOT required):

· Devices classified on risk categories I and II, except the ones that must be registered; · Simpler procedure compared with the registration process; · Around 70% of the medical materials and disposable articles are covered by this type of pre-market approval

In Vitro Diagnosis

Requirements

ANVISA's Resolution (RDC # 206/2006) · Four classes of risk (I ­ low, II ­ medium, III - high, III.A ­ selftest) · Regulatory requirements increase according to the categories of risk. · Based on potential risk for operator, patient and public health. · Full registration process for classes II, III and III.A, notification process to categories I IVD.

Future actions

Adoption of the Summary Technical Documentation STED for medical device registration process, according to GHTF guidelines:

- SG1-N11:2008

- SG1(PD)/N063

Other Control

· Third Party device certification made by accredited bodies for some categories of medical devices (Using the net of laboratories of `International Laboratory Accreditation Cooperation' - ILAC) = mandatory for some devices (Ex.: Family IEC 60601, gloves, condoms)

· Technical Analysis made by Anvisa is based on International Standards and Risk Analysis;

Inspectio

- National and international pharmaceutical and medical devices manufacturers are inspected regularly by ANVISA or by the Local Health Authorities with a frequency no longer than 2 years.

-

The GMP Standard for Drugs is Resolution RDC 17/2010, based on WHO/2003.

- The GMP Standard for Medical Devices is Resolution RDC 59/2000 based on FDA QRS (Part 820). There is no conflict between RDC 59/00 and ISO 13485;

- The inspectorate works continuously on the design, enhancement, and implementation of its internal Quality Systems.

Inspectio

The timeframe between the request and the company's certification is approximately 4 to 6 months, and includes, initial analysis, scheduling and performance of the inspection, inspection report preparation and the certification itself.

The timeframe for renewals is around 30 to 60 days.

In both situations the process is dictated by Standard Operating Procedures.

Statistics on Drug Inspection

International Inspection Requests 2010

60

50

50

40

35

30

26 22 22 19 17 15 12 15 15 13 8 6 3 3 4 5 3 3 2 1 1 2 3 3 2 0 8 16 16 22

20

10

0 Jan Feb Mar Apr May Jun Jul Aug

Total Requests for Initial International Certification 2010 USA Requests for Initial Certification 2010

Total Request for Certificate Renewal 2010 USA Requests for Renewal of Certificates

Statistics on Drug Inspection

Certificates Issued since 2008

500 450 404 400 350 300 250 200 150 100 50 0 International Certificates Issued in 2010 International Certificates Issued in 2009 International Certificates Issued in 2007 (Up to September) 87 47 443

331

Total USA

75

Statistics on Drug Inspection

Quantitative of International Inspections Performed by Anvisa for the Whole World

Quantitative of International Inspections Performed by ANVISA

250

204 200 189

157 150 141 121 128

157

100

50

0 2004 2005 2006 2007 2008 2009 2010 (Up to September)

Statistics on Drug Inspection

Wisconsin Washington Virginia Texas Pennsylvania Ohio North Carolina New York New Jersey New Hampshire Missouri Minnesota Michigan

5

6

Granted Certificates per State (Valid Status)

15

4

4

2 3 2 1

2

2

1

1

Massachussets 5 Maryland 3 Kansas 4 Indiana Illinois 4 Greenville 1 Georgia 1 Florida 4 Delaware 1 Colorado 2

16

11

California 18 16 14 12 10 8 6 4 2 0

Facing the challenges

Strategic Definition

· Maintenance of stable regulatory environment · Modernisation of the regulatory framework ­ Implementation of the Program for the Improvement of the Regulatory Process (Regulatory Agenda, Regulatory Impact Analysis, Good Regulatory Practices, ...) · Modernisation of the management and simplification of work flows; · Work closely to strategic partners for the implementation of international technical cooperation and for the international recognition of the Agency; · Keep helping Industries to develop products with safety, efficacy and quality.

Obrigado! Thank you!

[email protected] / [email protected] Phone #: + 55 61 3462-5402 Fax #: +55 61 3462-5414

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Dirceu Raposo ANVISA.ppt [Modo de Compatibilidade]

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