From a historical perspective and subsequent to the political changes in Central and Eastern Europe, the G-7 summit held in
Paris in mid-July 1989 established a special instrument of financial support for Poland and Hungary to Assist Restructuring
their Economies1 (PHARE) and later extended it to cover other European countries in transition. The PHARE program was one of the three pre-accession
instruments financed by the European Union (EU) to assist the applicant countries of Central and Eastern Europe in their preparations
for joining the EU.
In view of the EU enlargement in 2004, which was going to increase the number of member states from 15 to 25, there was a
need to prepare the candidate countries so that legislation and practices related to medicinal products would be equivalent
in all member states and in the European Economic Area (EEA) countries Norway, Iceland, and Liechtenstein, since these three
countries follow the EU regulatory framework for medicinal products.
Author Honored with Quality Award
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For that purpose, the Pan-European Regulatory Forum2 (PERF) was created. It went through several stages of development between 1999 and 2004, designated as PERF I, PERF II,
and PERF III. By the end of PERF I, the authorities considered the Good Regulatory Practices (GRP) a quality system and the
following description of GRP developed during PERF II: A quality system to ensure that the users of medicinal products, the
applicants, the regulators are satisfied with the scientific advice, opinions, the establishment of Maximum Residue Levels,
inspection and assessment reports and related documents, taking into consideration legal requirements and guidance in order
to protect and promote human and animal health.
The timely delivery of the services, the opinions provided by a regulatory authorities' network, and its quality and consistency
can only be ensured if quality and regulatory compliance is built into every step of the process, and the process capability
is enhanced by continual improvement. A network of regulatory authorities is not different from a regionally or globally acting
enterprise with subsidiaries in different countries, with the need for quality and consistency to ensure safety, efficacy,
and quality of their medicinal products. A network organization requires a smooth operation, which only can be achieved by
implementing an integrated quality management system. Benchmarking GRP
Benchmarking the management systems of the European competent authorities was proposed to assure the quality of the authorization
and supervision of medicines for human and veterinary use. Individual integrated (quality and risk) management systems were
compared using the ISO 9004:20003 (self)-assessment questionnaire, with the purpose of enriching, learning, and teaching to find best practices that are (cost)-effective,
efficient, and feasible. Benchmarking is about exchanging experience, about "ad hoc" consultancy by colleagues working in
a similar environment for different organizations but with a similar task, and it ensures continual improvement of the EU/EEA
Medicines Agencies' Network.
The use of an International Standard and Guidance for benchmarking allows mutual understanding between partners, not only
in the EU/EEA, but worldwide. Moreover, a questionnaire based on the ISO standard and guidance facilitates the implementation
of an ISO 9001:20001 quality management system by management with the endeavor to achieve ISO 9001:2000 certification of their
Agency.
During a benchmarking visit and assessment, which is different from an inspection or audit, there is a continuous enriching
interaction between the visiting colleagues from other agencies and visited staff and management. The assessment is fully
transparent, and the visiting team discusses and decides on the rating for an assessed process/system in the presence of management
and staff. It is this process of exchange that makes benchmarking such a good, value-adding tool.
