NATIONAL INSTITUTE FOR SURVEILLANCE OF FOOD AND DRUGS

NATIONAL INSTITUTE FOR SURVEILLANCE OF FOOD AND DRUGS – INVIMA. Dra. BLANCA ELVIRA CAJIGAS DE ACOSTA General Director Seúl, (Korea) February, 2015

COLOMBIAN REPUBLIC President: Juan Manuel Santos Calderón Population: 47’ 387. 109 inhabitants Area: 1. 141. 748 Km 2 land area and 928. 600 Km 2 and underwater area Administrative divisions: Colombia is divided into 32 departments and one capital district. Major cities: Bogota, Medellín, Cali, Barranquilla, Bucaramanga and Cartagena. Climate: It has 5 temperature zones including warm, temperate, cold moor and perpetual snows, with all the richness and biodiversity that these conditions pose

OUR COUNTRY NUESTRO Bogotá, capital district PAÍS COLOMBIA Cartagena de Indias Colombian Tourism San Andrés Islas Colombian footballers Colombian singer, Shakira

NATIONAL INSTITUTE FOR SURVEILLANCE OF FOOD AND DRUGS – INVIMA. Director: Dra. Blanca Elvira Cajigas de Acosta Location: Headquarters in Bogotá, capital district Officials : 1520 Plant. Territorial groups: nine (9) around the Country Laboratories: six (6)

STRATEGIC MANAGEMENT MISSION Protect and promote the health of the population through risk management associated with the consumption and use of food, drugs, medical devices and other products subject to sanitary surveillance. VISION Strengthen INVIMA´s recognition Nationally and Internationally as an articulator leader, concerning health and regulatory surveillance risk approach, committed to excellency in service, technical and scientific efficiency and the best technological standards, building trust, security and quality of life to the population.

SCOPE SANITARY ASSURANCE Issuance of Sanitary Registers and Mandatory Sanitary Notifications SANITARY SUPERVISION Inspection Surveillance Certification audits Control activities Sanctioning process Import and export approvals, inspection and certification at Standard Operating procedure National Reference Laboratory.

PRODUCTS UNDER INVIMA´S SURVEILLANCE Food Alcoholic and nonalcoholic beverages. Medicines Biological Products Medical devices In Vitro Diagnostic Reagents Tissues Bank– Reproductive Biomedicine Banks. Cosmetics Household Cleaning Products Personal Hygiene Absorbers

National Regulatory Agencies Regional Reference of ARNr Americas

SANITARY REGISTERS OF MEDICINES

ADVANTAGES FOR THE PHARMACEUTICAL INDUSTRY • Cooperation agreements and confidentiality in order to develop concrete actions to achieve regulatory convergence and facilitate access to markets. • Exchange of information for decision making from health records and issuing certificates BPM • Product Recall and fight against counterfeiting • Ecuador and El Salvador automatically recognize drug health records issued by r. RNA.

TO REQUEST AN ACCOUNTING NOTE : The Active Ingredient, strength and pharmaceutical form should included in pharmacological standards Can not be marketed drugs under investigation The manufacturer Laboratory of having Good Manufacturing Practices - BPM

COUNTRIES OF REFERENCE DECRETO 162 / 2004 USA Canada Germany Switzerland It is accepted if the certificate indicates: • Manufacturing áreas • Production processes and / or type of product or products France United Kingdom Denmark Netherlands Sweden Japan Noruega Mutual Recognition Agreements FDA OMS OPS EMA

SANITARY REGISTERS MODALITIES • Decree 677 of 1995, Article 14 Manufacture and sell Import, package and sell Import, half manufacture and sell Manufacture and export THE EFFECT OF SANITARY REGISTERS RECORDS IS FIVE (5) YEARS

PHARMACOLOGICAL EVALUATION Effectiveness Security Dosage Indications, contraindications, interactions and warnings - Benefit - risk Toxicity Pharmacokinetics Marketing conditions Special Restrictions

DRUG EVALUATION • Stability • Analytical methodologies– Validation Product quality • Reference Standards employees • Tags Manufacturing process Technical capacity manufacturer • Product Formula • Manufacturing process • Raw materials • Inputs • Manufacturing areas by product type • Manufacturing areas per dosage form • Manufacturing areas by type of active ingredient

STEP PROCESS Initial Filing Response Technical Study legal ¿Compliant? Technical Study - legal No Request No ¿Compliant? Yes Approval Yes Negation

SANITARY REGISTERS OF MEDICAL DEVICES

SURVEILLANCE DEVICES SURVEILLANCE PREMARKET Research, Innovation, development, design and manufacturing. OF MEDICAL MARKETING AUTHORISATION SURVEILLANCE POST-MARKET Technovigilance Health Registration Permission Marketing Reactivovigilancia Biomonitoring Verification of Quality TECHNOLOGY ASSESSMENT HEALTH SURVEILLANCE Fuente: Capitulo II Artículos 5, 6 y 7 del Decreto 4725 de 2005 Art. 5 del Decreto 4725 de 2005

CLASSIFICATION OF MEDICAL DEVICES RISK I IIA IIB III • LOW RISK SANITARY REGISTERS AUTOMATIC • MODERATE RISK • HIGH RISK • VERY HIGH RISK Fuente: Capitulo II Artículos 5, 6 y 7 del Decreto 4725 de 2005 SANITARY REGISTERS NO AUTOMATIC OR PERMISSION MARKETING Art. 5 del Decreto 4725 de 2005

CLASSIFICATION Invasiveness Affected system Effect on the patient Decreto 4725 de 2005. Artículo 5 Assets Duration of contact with the body: transitory, short term, long

SANITARY REGISTERS FOR MEDICAL DEVICES AND PERMISSION MARKETING MODALITIES The sanitary registers for medical devices and permission marketing for controlled biomedical equipment technology, be issued for the following categories: 1. Manufacture and sell. 2. Import and sell. 3. Import, pack and sell. 4. Import, half manufacture and sell. EFFECTIVE Sanitary registers and tradable permits, shall be valid for ten (10) years from the issue of the appropriate administrative action. Fuente: Artículos 27 y 31 del Decreto 4725 de 2005

MAIN TECHNICAL REQUIREMENTS CLASS IIA CLASS IIB CLASS III Technical Studies and analytical tests. • Verification and validation of design. • Certificate of analysis of the finished product. Sterilization method Method of disposal Studies biocompatibility, stability, cytotoxicity, electrical safety. Risk Analysis Description of security measures Clinical Studies Conformity Declaration: The commitment to provide the end user operating manual or user which are available in Castilian language and have available the maintenance and operation manuals Artículo 18 Decreto 4725 de 2005

THANK YOU FOR YOUR ATTENTION www. invima. gov. co Carrera 10 No. 64 – 28 - Bogotá, D. C. Colombia. Teléfono: (1)2948700 Manuel E. Valcárcel G. Mail: mvalcarcelg@invima. gov. co Teléfono: (1)2948700 ext 74019