IPQ Monthly Update — May 2011 in Review

In the forefront of the IPQ coverage for May are important initiatives going on in Europe to improve and harmonize its regulation of medicinal quality and the supply chain on which that quality depends.

In late May, the EU cleared its “Falsified Medicines Directive,” with far-reaching implications for industry responsibilities and the way these responsibilities will be monitored. The IPQ story reflects the insights, provided by a key EMA regulator involved, on the directive’s content, significance and implementation timelines and challenges.

A second story shifts focus onto the EMA initiatives to advance its biotech CMC policies, including removing some of the stumbling blocks for companies during the investigational phases and in clearing changes later in the product lifecycle.

The European coverage also delves into the regulatory challenges posed by the new generation of biologicals. The third story focuses on the soon-to-be-released overhaul of the EU’s 20-year-old GMP Annex 2 on biologics manufacturing, which will now encompass a wide variety of new product types from cell/tissue products to those transgenically derived from plants and animals. The story provides important insights from the Annex 2 revision’s rapporteur, Ian Rees, into the legislative, GMP/regulation and science drivers for the revision and what it is trying to accomplish.

The multifaceted concerns regulators face in overseeing the quality and integrity of ingredients and products moving through the shoals of the global supply chain are also explored in the IPQ coverage of the FDA developments during May.

In focus are: ● the adjustments CDER has made to the organizational structure and status of its compliance office to match the new challenges, and ● the problems agency investigators are finding in their overseas forays.

IPQ’s evaluation of foreign GMP warning letters issued in 2011 indicates investigator preoccupation with the integrity of lab data and whether failing results get the attention they demand. The integrity and communication issues prevalent abroad are also surfacing domestically as the other story in the series illustrates.

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