Download strengthening national regulatory authorities

STRENGTHENING NATIONAL REGULATORY AUTHORITIES
BUILDING CAPACITY THROUGH THE REVIEW
OF NATIONAL REGULATORY SYSTEMS
National Regulatory Authorities (NRAs) are responsible for the regulation and control of medical
products such as medicines, vaccines, blood products and medical devices. They contribute to
promoting and protecting public health by ensuring that:
• medicines are of the required quality, safety and efficacy,
• health professionals and patients have the necessary information to enable them to use
medicines rationally,
• medicines are appropriately manufactured, stored, distributed and dispensed,
• illegal manufacturing and trade are detected and adequately sanctioned,
• promotion and adverting is fair, balanced and aimed at rational drug use,
• access to medicines is not hindered by unjustified regulatory work.
Intensification of international commerce and increasing technological complexity of
manufacturing and product specifications have created additional challenges for national regulatory
authorities and manufacturers, particularly to those of developing countries. This requires that
national regulatory capacity is regularly reviewed, areas of weakness are identified and appropriate,
necessary measures are taken. Reviews are conducted using a standardized data collection tool .
OBJECTIVE OF REVIEWS OF NATIONAL REGULATORY SYSTEMS
Reviews aim at strengthening national regulatory and control capacity through an assessment of the
situation, the identification of specific needs, and the provision of appropriate technical support and
training.
TERMS OF REFERENCE FOR REVIEW TEAMS
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Review the existing legal framework, regulations and control activities with regard to
medicines, vaccines and medical devices in order to assess the national regulatory capacity
against a set of predefined parameters;
In collaboration with national officials, identify gaps and develop strategies to address these
gaps;
Identify specific areas and activities for WHO’s technical input.
TENTATIVE PROGRAMME OF A REVIEW VISIT
The duration of a review visit is in general three to five days divided into three phases. It can be
longer when field visits are necessary.
First day
Introduction and beginning
of review phase
Review phase
(up to day 3 or 4)
Last day: debriefing and
submission of summary
report
- Meeting with staff of the NRA to
introduce team, objectives and
expected outcome
- Decide review work plan
- Start review
Collection of information
based on standardised
data collection tool and
list of materials to be
submitted
- Presentation and discussion of
findings with relevant technical
staff, senior management and WR
- Amendments of the findings to
reflect discussions
- Copy of summary report including
Institutional Development Plan
provided by review team
REVIEW TEAM
The review team includes WHO staff, experts, and at least one national officer designated as focal
point by the country hosting the review visit. A member of the team will act as team leader and
present the summary report on behalf of WHO. Each team member will sign a confidentiality
agreement (annex 1) and a declaration (annex 2) on conflicts of interest before recruitment for a
review visit.
INSTITUTIONS AND PERSONS TO BE MET
The team will visit all institutions involved in the regulation and control of drugs and vaccines
and, where applicable, medical devices and blood products. In certain circumstances, it may be
appropriate to meet with senior officials and technical staff involved in procurement, reception,
storage and distribution of drugs and vaccines. These meetings aim at hearing their views and
gather information on how the regulatory processes affect their work. Where appropriate, visits to
local manufacturers will be organized focusing on the mechanisms of communication and control
established between manufacturers and national regulatory authorities. A visit of selected
manufacturing facilities could be organized and meetings set up to discuss problems encountered
by manufacturers in the implementation of GMP.
MATERIALS TO BE PREPARED IN ADVANCE BY NATIONAL COUNTERPARTS AND REVIEWED
BY THE TEAM
Availability of the documentation listed here below is crucial to the success of the assessment visit
and can even shorten it. It is therefore extremely important that such materials are collected
before the visit takes place and made available to the review team in electronic format or hard
copies. Put a date in the right-hand column if the documentation has already been provided to
WHO on the occasion of earlier visits and there is no more recent update.
DOCUMENTATION
Legal basis for regulation of drugs and vaccines, and, where applicable, medical devices and blood
products
Structures and operational aspects of drug and vaccine (and, where applicable, medical devices and
blood products) regulation at the different levels in the country
Comprehensive list of institutions, departments, and focal points involved in drug and vaccine (and,
where applicable, medical devices and blood products) regulation and procurement; if available
provide an updated organigramme dated and signed
List of drugs and vaccines (and, where applicable, medical devices and blood products) approved for
marketing and their sources
Number of doses of vaccines procured and administered in the last two years and forecast for the
coming year
Detailed list of vaccines (and their sources) used in national immunization programmes
National immunizations schedule
List of local drug and vaccine (and, where applicable, medical devices and blood products)
manufacturers and list of items produced
List of drug and vaccines (and, where applicable, medical devices and blood products) donations
received over the last two years
Drug and or Vaccine donation policy
Documentation on any collaborative activity or mutual recognition agreements with other national
regulatory authorities
Annual Reports or descriptive materials on the work of the national regulatory authority(ies), the
national inspectorate(s), the national quality control laboratory/ies, the national adverse
reaction/events monitoring system
Recent reports/studies on the different areas of work of the national regulatory authorities (e.g. product
licensing activities, inspectorate, quality control activities)
List of staff involved in regulatory system by regulatory functions
Budget allocated for regulatory activities including training
Training plan for regulatory staff including training provided and not completed or pending
Provided
EXPECTED OUTCOME
At the end of the visit, a presentation of the findings will be discussed first with national officials
in order to agree on the findings. Then a final presentation will be made to all senior staff. A
summary report will be provided outlining the findings and the outcome of the discussions held at
the end of the visit. An institutional development plan (IDP) will also be part of the report. The
IDP, which will reflect the discussions held with national officials, will include an outline of
possible technical support and training activities for all areas where weaknesses and needs have
been identified.
WHO will also propose that national experts, whenever identified during the visit, will be
recruited to participate in future review visits aimed at assisting NRAs of other countries.
CONFIDENTIALITY
All materials collected during the visit and the report will be treated as strictly confidential. They
will be available only to concerned WHO staff. The materials and copy of the report will be stored
at WHO and accessible only to authorised WHO staff. WHO will not provide copy of the report, the
materials collected, or any oral or written information related to the review to any persons or
institutions without the written authorisation of the country that has hosted the visit.
ANNEX 1
CONFIDENTIALITY UNDERTAKING BY TEAM MEMBERS PARTICIPATING IN
COUNTRY VISITS FOR THE REVIEWS OF THE NATIONAL REGULATORY
SYSTEM
In the course of country visits as an expert adviser to WHO you will have access to certain
information that belongs to the institutions that you will visit or to WHO or entities collaborating
with WHO. You undertake to treat such information (hereinafter referred to as “the Information”)
as confidential and proprietary to the aforesaid parties.
In this connection, you agree:
1. not to use the Information for any other purpose than those requested by WHO; and
2. not to disclose or provide the Information to any person who is not bound by similar
obligations of confidentiality and non-use as contained in this document.
However, you will not be bound by any obligations of confidentiality and non-use to the extent
that you are clearly able to demonstrate that any part of the Information:
1. was known to you prior to any disclosure by or on behalf of the institutions visited or WHO; or
2. was in the public domain at the time of disclosure by or on behalf of the institutions visited or
WHO; or
3. becomes part of the public domain through no fault of your own.
You also undertake not to communicate your findings and/or those of the team of experts in which
you will participate, as well as any resulting recommendations and/or decisions to any third party,
except if explicitly requested in writing by WHO.
You confirm that the information disclosed by you in the Declaration of Interest is correct and
that no situation of real, potential or apparent conflict of interest is known to you.
You undertake to promptly advise WHO of any change in the above circumstances, including if an
issue arises during the course of your work for WHO.
I hereby accept and agree with the conditions and provisions contained in this document.
Signed _________________________________________
Name (typewritten) _______________________________
Institute ________________________________________
Place ________________ Date _____________________
ANNEX 2
DECLARATION OF NO CONFLICTING INTERESTS
BY TEAM MEMBERS PARTICIPATING IN COUNTRY VISITS FOR THE REVIEWS
OF THE NATIONAL REGULATORY SYSTEM
In the course of country visits as an expert adviser to WHO you will have access to certain
information that belongs to the institutions that you will visit or to WHO or entities collaborating
with WHO. You undertake to treat such information (hereinafter referred to as “the Information”)
as confidential and proprietary to the aforesaid parties.
In this connection, you declare that:
- you will discharge your functions exclusively as adviser to WHO;
- no situation of real, potential or apparent conflict of interest is known to you, including that you
have no financial or other interest in, and/or other relationship with, a party, which:
- may have a vested commercial interest in obtaining access to any confidential
information obtained in the course of the review visit, and/or
- may have a vested interest in the outcome of the of the review visit including, but not
limited to, parties such as manufacturers of medicines or vaccines.
You undertake to promptly advise WHO of any change in the above circumstances, including if an
issue arises during the course of your work for WHO.
I hereby accept and agree with the conditions and provisions contained in this document.
Signed _________________________________________
Name (typewritten) _______________________________
Institute ________________________________________
Place ________________ Date _____________________