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.

Author Honored with Quality Award

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.

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