Good Regulatory Practices: Another Set of "Things to Do"?

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.

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.

Author Honored with Quality Award

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.

In the PERF framework, benchmarking visits to 17 Agencies/Ministries took place. The visiting teams consisted of EU National Competent Authorities, European Medicines Agency (EMEA) or European Directorate for the Quality of Medicines (EDQM) staff (auditors, inspectors or quality managers), and similar staff from, at that time, the EU candidate countries. The anonymous database, resulting from the PERF benchmarking assessments by the visiting teams, is available for National Competent Authorities (NCAs) at the EMEA, and is full of valuable information reinforcing the rating system thanks to the description of evidence substantiating the assigned rating.

Since the PERF benchmarking self-assessment and anonymous exchange of results was a useful tool for management of the EU/EEA Agencies' network, the European Commission assigned to the NCAs the task of developing the EU benchmarking system further with the EMEA for medicines for human use and veterinary use "to contribute to the development of a world class regulatory system for medicinal products based on a network of agencies operating to best practice standards."

Marijke Korteweg, PhD (Chem), PhD (Biochem), FIQA, is integrated quality management advisor, Directorate, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK, +44 (0) 20 7418 8556; fax +44 (0) 20 7418 8409, email: marijke.korteweg@emea.eu.intwww.emea.eu.int/

References

1. PHARE website: http://europa.eu.int/comm/enlargement/pas/phare/.

2. PERF III: The third Pan-European Regulatory Forum on Pharmaceuticals run from January to December 2003. The candidate countries involved in the PERF programme were Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, and Slovenia. The purpose of PERF III was to help candidate countries prepare their regulatory systems before accession to the EU. The benchmarking visits were funded by the European Commission PHARE programme for 10 Central and Eastern European candidate countries. Cyprus and Malta participated without PHARE support

3. ISO9004:2000 Quality Management Systems—Guidelines for Performance Improvements.

4. M. Korteweg, "Benchmarking of Good Regulatory Practice—Quality Management Systems in the Framework of PERF," The Regulatory Affairs Journals Ltd, 109–113 (February 2002).

5. M. Korteweg, "The Challenge to Ensure Good Regulatory Practices in a Growing Network of Authorities," Industrial Pharmacy, 5 (March 2005).

6. ISO9001:2000 Quality Management Systems—Requirements.