LEVEL OF ADOPTION AND IMPLEMENTATION OF THE TECHNICAL DOCUMENT N°7 “GUIDELINES FOR THE EVALUATION OF SIMILAR BIOTHERAPEUTICS PRODUCTS ” PANAMERICAN NETWORK ON DRUG REGULATORY HARMONIZATION ORGANIZACION PANAMERICANA DE LA SALUD

INTRODUCTION MAIN OBJECTIVES IN ORDER TO SUPPORT THE DEVELOPMENT OF THE STRATEGIC PLAN FOR PANDRH PERIOD 2014 - 2020, PAHO DEVELOPING A QUALITATIVE AND QUANTITATIVE ANALYSIS ON THE LEVEL OF ADOPTION AND IMPLEMENTATION OF 8 TECHNICAL DOCUMENTS FROM PANDRH. MAIN OBJECTIVES TO DETERMINE THE LEVEL OF ADOPTION OF 8 TECHNICAL DOCUMENTS FROM PANDRH IN ALL THE COUNTRIES OF THE REGION TO DETERMINE THE LEVEL OF IMPLEMENTATION OF 8 TECHNICAL DOCUMENTS FROM PANDRH IN 10 COUNTRIES OF THE REGION To describe the barriers, needs and strategies To identify the critical issues

IMPLEMENTATION THE DELPHI METHOD WAS USED. THE METHOD IS BASED ON: Adoption IMPLEMENTATION A STRUCTURED SURVEY WAS USED (ANSWER YES-NO). THE DATA WERE TREATED ACCORDING TO PERCENTAGE OF YES-NO ANSWERS SURVEYS WERE CONDUCTED TO THE TECHNICAL STAFF FROM THE NATIONAL REGULATORY AGENCIES OF ALL THE COUNTRIES O THE REGION THE DELPHI METHOD WAS USED. THE METHOD IS BASED ON: THE ANONIMITY THE REPETITIVINESS AND CONTROLLED FEEDBACK THE EVALUATING OF THE RESPONSES STATISTICALLY SURVEYS WERE CONDUCTED TO THE TECHNICAL STAFF FROM THE NATIONAL REGULATORY AGENCIES, FIFARMA AND ALIFAR OF 10 COUNTIES OF THE REGION (2 FOR EACH SUBREGION)

SELECTED DOCUMENTS TECHNICAL DOCUMENT Nº 1: HARMONIZED REQUIREMENTS FOR THE LICENSING OF VACCINES IN THE AMERICAS AND GUIDELINES FOR PREPARATION OF APPLICATION TECHNICAL DOCUMENT Nº 7: RECOMENDATIONS FOR THE EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs) TECHNICAL DOCUMENT Nº 8: FRAMEWORK FOR THE IMPLEMENTATION OF THE EQUIVALENCE REQUIREMENTS FOR PHARMACEUTICALS PRODUCTS GUIDE TO VERIFICATION OF GOOD MANUFACTURING PRACTICES GUIDE OF GOOD CLINICAL PRACTICES. DOCUMENT OF AMERICAS TECHNICAL DOCUMENT Nº 5: GOOD PHARMACOVIGILANCE PRACTICES GUIDES TECHNICAL DOCUMENT Nº 6: DOCUMENT ON SELF-EVALUATION OF GOOD LABORATORY PRACTICES (GLP) GUIDES FOR NRAs IN SUSPECTED COUNTERFEIT MEDICAL PRODUCTS

SIMILAR BIOTHERAPEUTICS PRODUCTS ANSWERS ADPTION STAGE ANSWERED BOLIVIA, BRAZIL, CANADA, COLOMBIA, COSTA RICA, CUBA, DOMINICAN R. , ECUADOR, EL SALVADOR, GUATEMALA, HONDURAS, MEXICO, NICARAGUA, PANAMA, PARAGUAY, PERU, URUGUAY, VENEZUELA

SIMILAR BIOTHERAPEUTICS PRODUCTS PERCENTAGE OF USE OF THE DOCUMENT ALL : PERU (IN PROCESS) PART : BRAZIL, BOLIVIA (IN PROCESS) , ECUADOR, VENEZUELA (IN PROCESS), COSTA RICA, GUATEMALA AND MEXICO NOT USED : COLOMBIA, URUGUAY, HONDURAS, EL SALVADOR, NICARAGUA, PANAMA, DOMINICAN R., CANADA AND CUBA

SIMILAR BIOTHERAPEUTICS PRODUCTS COUNTRIES IN WICH THE DOCUMENT IS NOT USED WITHOUT SPECIFIC REGULATON: COLOMBIA, URUGUAY, HONDURAS, EL SALVADOR, NICARAGUA, PANAMA, DOMINICAN REPUBLIC, WITH SPECIFIC REGULATION BUT BASED ON ANOTHER GUIDELINES : CANADA AND CUBA

SIMILAR BIOTHERAPEUTICS PRODUCTS COUNTRIES IN WICH THE DOCUMENT IS PARTIALLY ADOPTED TOPICS ADOPTED TOPICS NOT ADOPTED BY ONE OR MORE AGENCIES SELECTION OF RBP THE QUALITY REQUIREMENTS OF THE SBP MANUFACTURING PROCESS TECHNIQUES USED FOR CHARACTERIZATION OF SBPS AND RBPS PARAMETERS FOR BIOLOGICAL ANALYSIS ANALYTICAL TECHNIQUES USED FOR PRODUCT CHARACTERIZATION AND RELEASE CLINICAL STUDIES AND CLINICAL DATA PHARMACOVIGILANCE PARAMETERS PRESCRIBING INFORMATION AND PRODUCT LABELING ELEMENTS THAT SHOULD BE CONSIDERED FOR EXTRAPOLATION OF EFFICACY AND SAFETY DATA TO OTHER CLINICAL INDICATIONS NON CLINIC DATA

SIMILAR BIOTHERAPEUTICS PRODUCTS IMPLEMENTATION ANSWERED BY TECHNICAL STAFF from NRAs , fifarma and alifar FROM Bolivia , Brazil, Colombia, cuba, Guyana, México, panama and canada OBSTACLES AND CRITICAL ISSUES LACK OF SPECIFIC TECHNICAL STAFF LACK OF NRAs TECHNICAL STAFF TRAINING LACK OF SPECIFIC GUIDELINES OF SOME TOPICS OF THE DOCUMENT SPECIFIC STAFF PERFORMING ANOTHER TASKS IN COUNTRIES WITHOUT SPECIFIC REQUERIMENTS, SPONSORS OBJECT WHEN NRAs ASKING SOMETHING BASED ON DOCUMENT NEEDS SPECIFIC TRAINING SPECIFIC STAFF AND AREAS IN THE NRAs SPECIFIC GUIDELINES FOR SOME TOPICS ADEQUACY OF APPLICATIONS DURING THE TRANSITION STAGES STRATEGIES REGIONAL STRATEGIES FOR IMPLEMENTATION

CONCLUSIONS ONLY THE 5% OF THE COUNTRIES USED THE TECHNICAL DOCUMENT FOR DEVELOPING THEIR REQUIREMENTS THE 39% USED PART OF THE DOCUMENT Because they have previous regulation Because they don’t adopt a specific item (for example most of the countries don’t adopt the item 18: PANDRH TECHNICAL REPORT Nº. 7 provides detailed guidance on how pharmacovigilance of SBPs should be carried out. Was this information used in the preparation of SBPs pharmacovigilance requirements by your NRA? THE 56% NOT USED THE DOCUMENT Because they don’t have specific regulation Because they have previous regulation but based on another guidelines THE MAIN OBSTACLES FOR THE IMPLEMENTATION ARE: Lack of specific staff, Lack of specific training programs and Lack of specific guidelines of some topics included in the document

GRACIAS THANKS MERCI OBRIGADO