WHO Data Collection Tool for the Review of Medicines Regulatory Systems Dr Samvel Azatyan Technical Officer Regulatory Support Quality Assurance and Safety: Medicines Essential Medicines and Pharmaceutical Policies World Health Organization E-mail: azatyans@who.int

Medicines as an instrument of public health Medicines regulation is the totality of all measures - legal, administrative and technical - which governments take to ensure the safety, efficacy and quality of medicines, as well as the relevance and accuracy of product information In the meantime… Medicines are produced and sold primarily "for business" Many pharmaceutical companies are shareholders companies; Under law the shareholders companies are OBLIGED to earn profit for shareholders.

Rationale for Government role Consequences of weak drug regulatory capacity irrational consumption and prescription; substandard, counterfeit, harmful, useless drugs on the market Public health and safety concerns have obliged governments to intervene in the activities of the pharmaceutical sector.

Medicines as an instrument of public health In this regard – Medicines regulation is a public policy that restricts private sector activities in order to attain social goals set by the State.

Medicines regulation Different models for regulation of medicines exist across the world and they are determined by: Size of the pharmaceutical market; Availability of resources; Public health needs.

Four dimensions of the medicines regulation Authority and capacity

Regulatory capacity 193 WHO Member States:

Regulatory decision making May be performed by different agencies, Ministry of Health etc.; The decision making may be delegated; This delegation of responsibility is based on capacity, and competencies to assess the quality, safety and efficacy of drugs before approval is granted.

Capacity to make regulatory decisions For various reasons, many regulatory authorities do not have the full capacity to make a complete assessment of the application for registration of medicines; -- Should rely on the assessment of other authorities, e.g., CPP; The processes of decision making and marketing authorization are not always well defined; -- External expert advice and support are necessary to address these issues.

Critical issues Not all regulatory functions are performed due to chronic shortages of human and technical resources Weak regulatory frameworks and lack of enforcement can lead to various bottlenecks limiting access to essential medicines Different institutional arrangements for the regulation of medicines

Development of regulatory capacities ...occurs in phases, over a long period of time, depending on: level of development of the pharmaceutical sector; availability of trained human resources; infrastructure, the size and sophistication of the regulatory authority; financial resources.

Assessment of regulatory capacities Countries should assess their drug regulatory performance using indicators that focus on structures and inputs, processes and outcomes; They should identify any strengths and weaknesses, the reasons for them and consider alternative regulatory options, using the most appropriate and practical choices; WHO Data Collection Tool for the review of Drug regulatory Systems has been designed to help regulatory authorities to perform an assessment.

Assessment of regulatory capacities Each regulatory assessment should be organized based on the following steps: planning, preparation, site visit, report, action plan, follow up.

Regulatory Assessment Process Expression of a need Assessment team Preparation Visit Opening session (Briefing) Performing the assessment Closing session (presentation of the main findings) Follow-up (report).

Assessment Methodology An assessment should not be based on impressions, feelings or any subjective considerations. Evidence may be collected by different means such as: Interviewing personnel.  Reading documents.  Reviewing manuals.  Studying records. Reading reports. Scanning files. Analyzing data.  Observing activities.  Examining conditions. 

Structure of the assessment tool 1. General information - Module 1 1.1. Information on the country - General indicators - Health care systems indicators 1.2.Information on the assessment - The purpose, the scope and the assessment team. This part should provide for a clear understanding of the focus of the assessment.

Structure of the assessment tool 2. National Regulatory System - Module 2 2.1. Organization - all institutions, autonomous bodies, professional bodies, regulatory bodies, health institutions and any third party involved in the definition, implementation, compliance, enforcement and prosecution related to the regulation of pharmaceutical products. - regulatory functions that each institution is responsible for and the categories of regulated products 2.2.Legal basis for the establishment of the regulatory system

Structure of the assessment tool 3. National Regulatory Authority - Module 3 3.1. Legal basis - applicable legal requirements and if adequate, the regulations enacted to make the legislation precise 3.2.Corporate Governance (management) - the organization of the day to day work, - the establishment of a prospective strategy, - the evolution of the scientific environment.

Structure of the assessment tool 3.3. Institutional Development The NRA should elaborate the objectives regarding the regulatory functions performed and should monitor the achievement of such objectives using appropriate indicators which can be quantitative or qualitative, for example: - Number of applications received (per year), - Number of marketing authorizations granted (per year), - Percentage of MAs granted within a timeframe/objective of 6 months/related to applications submitted

Structure of the assessment tool 3.4.Organization and structure - The assessor should identify the organization set in place to exert the regulatory functions; i.e. determine if the same function is delegated or decentralized and in particular what level of the country (central, regional or local level) is mobilized. - If different organizations at different levels of the state are involved the assessor should review the linkage among the organizations particularly how the exchange of information is established and implemented.

Structure of the assessment tool 3.5. Quality Management System - Quality Manager designation and job description - Quality Manual, - Procedure for documentation control (manual, procedures and records) - Management review records, - Quality policy and objectives, - Quality Plan, - Quality indicators (timeframe, reporting), - List of internal procedures and forms, - Procedure for planning, implementing internal audit and following up with corrections - Audit reports and follow-ups - Procedures for the investigation of non-compliance and records maintained, - Procedures for dealing with complaints and records maintained. - Procedure for initiation, decision and implementation of corrective and preventive actions and check efficiency and records

Structure of the assessment tool 3.6. Funding - List of fees applicable for licensing, registration or authorization - NRA's budget - Funding agreements The availability of an adequate budget is essential to provide salaries that will attract personnel with the required training and experience, as well as the facilities and infrastructure needed. The assessor should determine if the NRA has the authority to charge, collect and utilize internally the funds it generated for regulatory services provided.

Structure of the assessment tool 3.7.Management of human resource - NRA's organigram/organization charts - Internal procedures for recruiting, training and qualifying staff and records - Procedure for assessing the impact of training activities - Procedure for assessing the competencies of the staff - Code of conduct/code of ethics - List of staff with their qualification - Training plan - List of trainings performed - Job descriptions - Curriculums Vitae - Recruitment plan

Structure of the assessment tool 3.8.Committees and external expertise 3.9.Transparency and confidentiality 3.10. Independence and impartiality 3.11. Infrastructure 3.12. Monitoring and accountability 3.13.Information management systems 3.14. Communication activities

Structure of the assessment tool 4. Marketing Authorization (MA) - Module 4 4.1. Legal basis 4.2. Guidelines 4.3. Organization and structure 4.4. Assessment procedure 4.5. Human and other resources 4.6. Records and outputs 4.7. Availability of information

Structure of the assessment tool - Licensing of Manufacturers – Module - Licensing of importers, exporters, wholesalers and distributors - Module 6 - Licensing of pharmacies and retail outlets - Module 7 - Registration of pharmacy personnel - Module 8 - Post marketing surveillance and controls - Module 9 - Control of drug promotion and advertising - Module 10 - Pharmacovigilance - Module 11 - Clinical Trials - Module 12 - Regulatory inspections and enforcement activities - Module 13 - Quality Control Laboratory - Module 14 - Control of Narcotics, Psychotropic Substances and Precursors - Module 15 - International cooperation and harmonization - Module 16

Conclusions WHO Data Collection Tool is a practical instrument for the review of Medicines Regulatory Systems; Review could be done both as a self-assessment or external assessment; The tool could help countries to identify their existing gaps and to develop a plan of corrective actions; The tool is dynamic and could be adjusted to the changing environment and situation.

Thank you!