1. 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

2. INTRODUCTION MAIN OBJECTIVES
IN ORDER TO SUPPORT THE DEVELOPMENT OF THE STRATEGIC PLAN FOR PANDRH PERIOD , 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

3. 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)

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. GRACIAS THANKS MERCI OBRIGADO