EDQM: Harmonized generic drug reviews would help regulators, pharmas and patients

By Gareth Macdonald

- Last updated on GMT

EDQM headquarters in Strasbourg, France
EDQM headquarters in Strasbourg, France

Related tags Food and drug administration Council of europe Edqm

Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.

The European Directorate for the Quality of Medicines (EDQM), which is responsible for the European Pharmacopoeia, stressed the benefits of closer international alignment ahead of a workshop​ for regulators it is hosting at its headquarters in Strasbourg on May 13.

A spokeswoman told us “more regulatory harmonisation in term of requirements and collaboration means more speedy and efficient assessment of dossiers and quicker access to the market​.”

The workshop the EDQM will host next week is part of the International Generic Drug Regulators Programme (IGDRP), which was set up a group of national regulators in 2012 to encourage information exchange. Topics discussed by the attendees will include biowaivers, active substance and drug master files and inspections.

The idea is to “promote collaboration and convergence in generic drug regulatory programmes in order to address the challenges posed by increasing workloads, globalisation and complexity of scientific issues​.

The overall aim is to get the right quality of generic drugs to the maximum number of patients through convergence in requirements, standards and processes​.”

EMA and WHO efforts

The efforts are in line with similar initiatives by the European Medicines Agency (EMA), which announced​ its intention to “share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union​” in 2015.

It is also in keeping with a call for collaboration on generic drug reviews issued by the World Health Organisation (WHO) in 2014​.

At the time the WHO said: “The pre-market review of generic medicines puts mounting pressures on health regulatory authorities around the world due to increasing workloads and risks associated with complex global supply chains.”

EDQM workshop

In addition to regulators, the EDQM invited drug manufacturers, professionals working in pharmaceutical development, QC, QA and regulatory affairs to attend the workshop in Strasbourg next week (details here​).

CORRECTION: The IGDRP is an initiative set up by various national regulatory agencies​ and not by the EDQM as originally stated.

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