Transcript Structure of the assessment tool

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: [email protected]
1|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
2|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
3|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
4|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
5|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
Four dimensions of the medicines
regulation
Authority and capacity
6|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
Regulatory capacity
193 WHO Member States:
50%
20%
30%
Developed
Varying
Limited
7|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
8|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
9|
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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
10 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
11 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
12 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
Assessment of regulatory capacities
 Each regulatory assessment should be organized
based on the following steps:
-
13 |
planning,
preparation,
site visit,
report,
action plan,
follow up.
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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).
14 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
15 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
16 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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
17 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
18 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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
19 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
20 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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
21 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
22 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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
23 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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
24 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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
25 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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
26 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
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.
27 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland
Thank you!
28 |
Post-ICDRA DRUGNET Meeting | 20 September 2008, Bern, Switzerland