The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs

EMA to Juggle Brexit and New Quality and Safety Guidelines Next Year

Jan. 5, 2018

In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component.

However, the goals could be subject to change — especially as the EMA faces a challenging year with the changes brought by Brexit, according EMA’s Executive Director Guido Rasi.

“Preparing for the agency’s move to Amsterdam and the United Kingdom’s withdrawal from the European Union will occupy the time of many staff members that we would rather spend on activities that make a difference to public health,” said Rasi, in an end of the year message to stakeholders. “We will have to refocus on our core tasks and adjourn some initiatives.”

The quality and safety working groups’ work plans list the EMA guidelines, reflection papers and other contributions they hope to produce, with quarterly target dates, over the next three years.

The EMA’s joint quality working party, covering both human and veterinary products, plans to focus on developing a draft guideline on the equivalence of topical products, and deliver input on reflection papers covering statistical methodologies for assessing quality attributes and equivalence studies for products targeting the gastrointestinal tract — as well as an overview of regulatory testing requirements and opportunities to implement the replacement, reduction and refinement of medicines.

The safety working party will take the lead on guidelines for non-clinical evaluation of radiopharmaceuticals and environmental risk assessments, as well as several ICH guidelines, Q&A documents and revisions, through monthly virtual and face-to-face meetings.

Both groups will also continue to liaise with the FDA and other international regulators and scientific institutes.